HIV-positive women respond well to HPV vaccine

HIV-positive women respond well to a vaccine against the human papillomavirus (HPV), even when their immune system is struggling, according to newly published results of an international clinical trial. The study's findings counter doubts about whether the vaccine would be helpful, said the Brown University medical professor who led the study. Instead, the data support the World Health Organization's recommendation to vaccinate women with HIV.

HPV causes cervical and other cancers. The commonly used HPV vaccine  had not been tested in seriously immune-suppressed women with HIV, said Dr. Erna Milunka Kojic, associate professor of medicine at the Warren Alpert Medical School of Brown University and The Miriam Hospital. Despite the WHO recommendation, she said, skeptics have wondered whether the vaccine would be safe and helpful for women with weakened immune systems who were already likely to have been exposed to HPV through sex. Vaccines are often less effective in HIV-positive people.

To address that debate, Kojic's study, dubbed "AIDS Clinical Trials Group Protocol 5240," measured the safety and immune system response of the vaccine in HIV-positive women aged 13 to 45 with a wide range of immune statuses. In the vast majority of the 315 volunteers who were vaccinated at sites in the United States, Brazil, and South Africa, the vaccine built up antibodies against HPV and posed no unusual safety issues during the 28 weeks they were each involved.

"The vaccine works for HIV-infected women in terms of developing antibodies," Kojic said.

Co-author Dr. Susan Cu-Uvin, professor of public health and of obstetrics and gynecology at Brown, said women with HIV are especially susceptible to cervical cancer from HPV because their weakened immune systems are less able to clear the virus. That makes vaccinating HIV-positive women especially important, so long as it's safe and they respond.

"This is a very safe vaccine. It doesn't have any systemic side effects among these women who are already taking medicine for other conditions."

Response across the board

To investigate that response in the context of HIV, the study grouped women by their CD4 cell count, a measure of immune system health. Group A had CD4 counts above 350, group B rested between 200 and 350. Group C was composed of women with counts below 200, the defining level of AIDS for which response to an HPV vaccine had not yet been studied.

 "Quadrivalent" vaccine, in that it protects against four types of HPV (6, 11, 16, and 18). Each group in the study, therefore, had four measures of "seroconversion," or the buildup of a significant army of antibodies against each type of HPV. The researchers determined that seroconversion in at least 70 percent of patients for each HPV type would define success.

"Seroconversion proportions at week 28 among women in CD4 stratum A were 96 percent, 98 percent, 99 percent, and 91 percent for HPV types 6, 11, 16, and 18 respectively; in stratum B, 100 percent, 98 percent, 98 percent, and 85 percent; and in stratum C, 84 percent, 92 percent, 93 percent and 75 percent for each type respectively," the authors wrote.
Seroconversion rates were clearly lower for women with the weakest immune systems, but still high enough to be worthwhile, Kojic said. And although some of the women in the study had already been exposed to at least one type of HPV, only 1 in 25 had been exposed to all four, suggesting that even older, sexually active women can benefit from vaccination.

The extent of the benefit, she acknowledged, is not yet clear because the trial did not measure the vaccine's efficacy in preventing cancers. It only measured safety and the number of patients who had the desired immune system response. But that response has been shown to be effective in other studies of other populations of women.

What is clear from the study is that the vaccine produced no more side effects or problems than any vaccine typically does.

"Comparing vaccine reactions, this is a very safe vaccine," Kojic said. "It doesn't have any systemic side effects among these women who are already taking medicine for other conditions."

Kojic said she hopes that by confirming that women with HIV are responsive to the vaccine without unusual adverse effects, more doctors will vaccinate HIV-positive patients.

Low cholesterol in immune cells tied to slow progression of HIV

People infected with HIV whose immune cells have low cholesterol levels experience much slower disease progression, even without medication, according to University of Pittsburgh Graduate School of Public Health research that could lead to new strategies to control infection.

The Pitt Public Health researchers found that low cholesterol in certain cells, which is likely an inherited trait, affects the ability of the body to transmit the virus to other cells. The discovery, funded by the National Institutes of Health (NIH).

When HIV enters the body, it is typically picked up by immune system cells called dendritic cells, which recognize foreign agents and transport the virus to lymph nodes where it is passed to other immune system cells, including T cells. HIV then uses T cells as its main site of replication. It is through this mechanism that levels of HIV increase and overwhelm the immune system, leading to AIDS. Once a person develops AIDS, the body can no longer fight infections and cancers. Prior to effective drug therapy, the person died within one to two years after the AIDS diagnosis.

"We've known for two decades that some people don't have the dramatic loss in their T cells and progression to AIDS that you'd expect without drug therapy," said lead author Giovanna Rappocciolo, Ph.D., an assistant professor at Pitt Public Health. "Instead the disease is much slower to progress, and we believe low cholesterol in dendritic cells may be a reason."

The discovery was made possible by using 30 years of data and biologic specimens collected through the Pitt Men's Study, a confidential research study of the natural history of HIV/AIDS, part of the national NIH-funded Multicenter AIDS Cohort Study (MACS).

"We couldn't have made this discovery without the MACS. Results like ours are the real pay-off of the past three decades of meticulous data and specimen collection," said senior author Charles Rinaldo, Ph.D., chairman of Pitt Public Health's Department of Infectious Diseases and Microbiology, and professor of pathology. "It is thanks to our dedicated volunteer participants that we are making such important advances in understanding HIV, and applying it to preventing and treating AIDS."

Medications called combination antiretroviral therapy (ART) disrupt the viral replication process and can delay the onset of AIDS by decades.

However, even without taking ART, a small percentage of people infected with HIV do not have the persistent loss of T cells and increase in levels of HIV after initial infection. They can sometimes go many years, even more than a decade, without the virus seriously compromising the immune system or leading to AIDS.

Through the Pitt Men's Study/MACS, eight such "nonprogressors" were assessed twice a year for an average of 11 years and compared to eight typically progressing HIV-positive counterparts.

Dr. Rappocciolo and her colleagues found that in nonprogressors, the dendritic cells were not transferring the virus to T cells at detectible levels. When taking a closer look at these dendritic cells, the researchers discovered that the cells had low levels of cholesterol, even though the nonprogressors had regular levels of cholesterol in their blood. A similar finding was shown for B lymphocytes, which also pass HIV to T cells, leading to high rates of HIV replication.

Cholesterol is an essential component of the outer membranes of cells. It is required for HIV to replicate efficiently in different types of cells. None of the study participants were taking statins, which are cholesterol-lowering medications that some people take to prevent vascular problems when cholesterol in their blood is too high.

When HIV was directly mixed with the nonprogressors' T cells in the laboratory, those T cells became infected with the virus at the same rate as the T cells of the regularly progressing, HIV-positive participants. Indeed, T cells from the nonprogressors had normal levels of cholesterol.

"This means that the disruption is unlikely to be due to a problem with the T cells, further supporting our conclusion that the slow progression is linked to low cholesterol in the dendritic cells and B cells," said Dr. Rappocciolo.

"What is most intriguing is that dendritic cells in the nonprogressors had this protective trait years before they became infected with HIV," Dr. Rinaldo said. "This strongly suggests that the inability of their dendritic cells and B cells to pass HIV to their T cells is a protective trait genetically inherited by a small percentage of people. Understanding how this works could be an important clue in developing new approaches to prevent progression of HIV infection."

Sustanon 250

Sustanon 250, a strong anabolic with pronounced androgenic activity, is considered by many as one of the most powerful combinations of testosterone.

Originally developed by the international drug firm Organon as an alternative to hormone replacement therapy (HRT), this anabolic androgenic steroid contains four different testosterone esters: Testosterone propionate (30 mg), testosterone phenylpropionate (60 mg), testosterone isocaproate (60mg), and testosterone decanoate (100 mg) that stimulate a fast yet extended release of testosterone.

Sustanon 250 has the chemical name of 17ß-hydroxyandrost-4-en-3-one and can be detected over a period of 2-3 months. This steroid has an active life of nearly 2-3 weeks and the molecular formula of Sustanon 250 is C19H28O2.

Sustanon 250 is one of the most commonly recommended drugs for the development and maintenance of reproductive tissues such as the prostate, epididymis, seminal vesicles, testes, and penis even at low doses. Sustanon 250 also has the ability to prevent degeneration of existing muscles in wasting diseases and is prescribed to individuals diagnosed with HIV/AIDS. Sustanon 250 can easily promote muscle function, muscle size, body strength, and nitrogen retention gains and also has the potential to improve plasma concentrations of Testosterone, Dihydrotestosterone, Oestradiol (estrogen hormone), and Androstenedione. Most athletes and bodybuilders use this steroid to experience improvements in the level of sexual function, such as libido and erectile function and reduction in the levels of serum LDL-C, HDL-C, and triglycerides.

When used as per medical advice, Sustanon 250 can even stimulate improvements in levels of hemoglobin and Hematocrit without resulting in any clinically relevant changes in liver enzymes and PSA. Sustanon 250 is commonly used by athletes as a bulking drug that leads to exceptional strength and muscle mass gains. Sustanon 250 does convert to estrogen but it is slightly more tolerable than testosterone cypionate or enanthate. This is primarily because blood levels of testosterone build slowly with the use of this steroid and it means that side effects do not happen fast.

Testosterone Cypionate - still the best possible mass builder in the world.

Testosterone is the prime male androgen in the body, and as such still the best possible mass builder in the world. It has a high risk of side-effects because it readily converts to a more androgenic form (DHT) in androgen responsive tissues and forms estrogen quite easily. But these characteristics also provide it with its extreme anabolic tendencies. On the one hand estrogen increases growth hormone output, glucose utilization, improves immunity and upgrades the androgen receptor, while on the other hand a testosterone/DHT combination is extremely potent at activating the androgen receptor and eliciting major strength and size gains. While not always the most visually appealing result, there is no steroid on earth that packs on mass like testosterone does.

Testosterone Cypionate is a single-ester, long-acting form of testosterone. Due to the length of its ester (8 carbons) it is stored mostly in the adipose tissue upon intra-musuclar injection, and then slowly but very steadily released over a certain period of time. A peak is noted after 24-48 hours of injection and then a slow decline, reaching a steady point after 12 days and staying there for over 3 weeks time. Of course most users of anabolics will not find adequate benefit in the use of this steady-point dose, so Testosterone Cypionate is normally injected once a week, making the very lowest dose higher than half the peak dose at any given time. This is roughly the starting blood level as well. A long-acting testosterone ester is a must-have in any mass-building cycle. As such Testosterone Cypionate is a very decent product.

Personally I have more affinity for Testosterone Enanthate, but few users will note any real difference between the two products, and both remain a better buy than their popular counterpart sustanon 250, which is a poor choice of testosterone in my opinion. It makes sense that a user simply opts for which one is most readily available at the time. They sell for roughly the same price, and are almost equally good. So most North and South-American users will usually opt for the use of a cypionate, as it is more available in those regions, whereas Europeans and Asians will probably prefer the enanthate version.

A long-acting testosterone ester may be the best for all your mass-building needs, but its not an easy product to use. Because of the extreme length of action (3-4 weeks) one cannot easily solve occurring problems by simply discontinuing the product, as it will continue to act and aggravate side-effects over extended periods of time. In regards to damage control and post-cycle therapy, some familiarity with the use of ancillary drugs is required prior to using a long-acting testosterone product. Nolvadex and Proviron will come in very handy in such cases and post-cycle HCG and clomid or Nolvadex will be required as well to help restore natural testosterone. Frequency of side-effects is probably highest with this type of product.

While most will tell you it's a waste to not use testosterone, as it will take ages longer to build proper mass, these are all points to take into consideration. Testosterone is a product that is heavily used by beginners and veterans alike and justly so. Those who fear they may never understand the proper use of ancillary drugs, may want to suck it up and invest in some propionate or suspension testosterones instead. These are much shorter acting and easier to control, but they do need to be injected once every two days, whereas this type of ester will impart great gains with a single weekly injection. Something to keep in mind.

Testosterone is the most powerful compound there is, so obviously its perfectly fine to use it by itself. With a long-acting ester like Testosterone Cypionate doses of 500-1000 mg per week are used with very clear results over a 10 week period. If you've ever seen a man swell up with sheer size, then testosterone was the cause of it. But testosterone is nonetheless often stacked. Due to the high occurrence of side-effects, people will usually split up a stack in testosterone and a milder component in order to obtain a less risky cycle, but without having to give up as much of the gains. Primobolan, Equipoise and Deca-Durabolin are the weapons of choice in this matter. Deca seems to be the most popular, probably because of its extremely mild androgenic nature. But Deca being one of the highest risks for just about every other side-effects, I probably wouldn't advise it. If Deca is used, generally a dose of 200-400 mg is added to 500-750 mg of testosterone per week.

Primobolan is sometimes opted for, and can be handy since it doesn't aromatize, which will make the total level of water retention and fat gain a lot less than with more test or with Deca for example. Unfortunately, its mild nature combined with a lack of estrogen make Primobolan a very poor mass builder. Again, doses of 300-400 mg are used. I would actually suggest a higher dose, but with the current prices for Primo I don't think it would be very popular. My personal preference goes out to Equipoise. Androgenically its not that much stronger than Deca because it has next to no affinity for the 5-alpha-reductase enzyme and is only half as androgenic as testosterone. Its twice as strong as Deca, mg for mg, and has a lower occurrence of side-effects. It has some estrogen, but not a whole lot so it actually tends to lean a person out rather than bloat him up as Deca will. It also increases appetite, which promotes gains, and improves aerobic performance, which may be wishful as testosterone normally has an opposite effect.

Of course Testosterone Cypionate can be stacked with any number of compounds apart from these, but these make the best match. When stacking with testosterone, one needs to look at what the other compound can bring. Either it has a characteristic that testosterone doesn't have, or its nominally safer. The testosterone will bring all the mass, so adding another steroid to enhance mass alone, is futile. More testosterone is the best remedy for that.

One needs to be familiar with a host of other compounds when using long-acting testosterone esters however. First of all, anti-estrogens. The rate of aromatization of testosterone is quite great, so water retention and fat gain are a fact and gyno is never far off. If problems occur one is best to start on 20 mg of Nolvadex per day and stay on that until problems subside. I wouldn't stay on it for a whole cycle, as it may reduce the gains. In terms of an aromatase blocker, testosterone is one of the few compounds where Proviron may actually be preferred over arimidex. The proviron will not only reduce estrogen and can be used for extended time on a testosterone cycle, it will also bind with great affinity to sex-hormone binding proteins in the blood and will allow for a higher level of free testosterone in the body, thus improving gains.

Usually 50-100 mg will suffice, the lower end is preferred for maximal results since estrogen plays a key role in gains, but those more worried about estrogen should opt for a higher dose. For those worried about androgenic side-effects (hair loss, prostate hypertrophy, deepening of voice), one can utilize the hair loss treatment finasteride. This blocks the 5-alpha-reductase enzyme and stops the conversion of testosterone to the more androgenic compound DHT. I'm not a big fan of this, because DHT reduces estrogenic bloat, increases free levels of testosterone and is a very potent androgen that is 3-4 times stronger than testosterone. Those worried about hair loss however, may want to opt for arimidex as their anti-aromatase, since Proviron is a form of DHT after all. After a cycle, mainly due to the high aromatization and increased levels of estradiol in the blood after discontinuing, natural testosterone levels will be severely suppressed. This means steps need to be taken to assure the quick return of natural testosterone, or we stand to lose a lot of the gains we made while using testosterone. Since it's a non-toxic, potent mass-builder its mostly used in long 10-12 week cycles. So some testicular shrinkage will have occurred too. Its very important that people see that HCG and Nolvadex/clomid are essential as a post-cycle therapy, and that both are equally important in achieving our goal. HCG injections should be started the last week of the cycle and continued for 3-4 weeks, using 1500-3000 IU every 5-6 days. HCG will act as an alternative to LH and start the endogenous testosterone cycle, thereby increasing testicle size once again. Then about 2 weeks after the last shot of testosterone is given, Nolvadex/Clomid cycle should be started. 40 mg of Nolva or 150 mg of Clomid per day for two weeks, followed by two more weeks with either 20 mg of Nolva or 100 mg of Clomid per day should be adequate. Always remember that HCG is suppressive of natural testosterone itself and should be discontinued at least 2 weeks prior to finishing Nolvadex/Clomid.

The Effects of HIV on the Body

What does human immunodeficiency virus (HIV) look like?

Though symptoms can go undetected for some time, eventually the disease takes its toll on the body by damaging a person’s immune system, paving the way for numerous diseases to move in. While many of the diseases and infections that strike people with HIV are common, others are unusual and their presence is what often leads to a diagnosis of acquired immune deficiency syndrome (AIDS) — the final stage of HIV disease.

HIV: Early Symptoms

The earliest symptoms of HIV can resemble the flu and they generally clear up within a month or two. These symptoms may include fever, headache, fatigue, and swelling in the lymph nodes, particularly those in the neck and groin. However, not everyone who acquires HIV will experience these symptoms. Similarly, for several years, perhaps as long as a decade, a person with HIV may not have any symptoms at all. During that time, though, the virus is still multiplying and it's possible to transmit HIV to someone else.

HIV progresses differently for each person affected. The course of the disease is determined by the specific infections or complications a person with HIV develops. HIV complications can affect different parts of the body: Some are localized to the mouth, others in the brain, and others result in total body changes like losing body weight. Skin conditions are also common.

HIV: Skin Effects

Several of the main skin conditions that affect people with HIV are caused by viruses most people already have in their bodies. However, these viruses typically do not cause disease in people whose immune systems are healthy. Some of the more common dermatological, or skin, effects of HIV include:

• Varicella zoster virus (VZV) infection. VZV is a herpes virus that causes both chicken pox (varicella) and shingles (herpes zoster). Most adults have already been exposed to this virus. HIV-infected individuals may develop new skin sores from either of these diseases. HIV patients who didn’t have chicken pox earlier in their life may develop the condition, which in some cases can affect their organs and become life-threatening. Shingles can be localized to one area or it can spread over large areas of the skin. Shingles lesions can become infected and even lead to the development of encephalitis (brain inflammation) in people with HIV.
• Herpes simplex virus (HSV). HSV was one of the first diseases identified in people with advanced HIV disease and is now considered one of the AIDS-defining diseases by the U.S. Centers for Disease Control and Prevention. HSV causes open sores that may look like a cluster of blisters. They pop and crust over before healing completely; this process takes about 7 to 10 days in otherwise healthy individuals, but in people with advanced HIV disease, the sores may enlarge to 2 to 10 centimeters in diameter, becoming crusted and painful.
• Kaposi’s sarcoma (KS). KS is a cancer caused by a herpes virus called Kaposi sarcoma herpes virus. Healthy individuals may be infected with Kaposi sarcoma herpes virus without developing the cancer. However, as HIV-infected people become sicker, KS may develop. KS tumors grow from cells that line blood vessels and lymph nodes. The cells form tumors on the skin that appear as brown, purple, or red splotches, called lesions. In some cases, the lesions look worse than they are, as they may cause no other symptoms. Other people with KS may experience painful swelling, particularly around the eyes, in the legs, or in the groin. Although less common, KS lesions can also form in organs, like the liver, digestive system, or the lungs, which could be deadly.

HIV: Oral Health Problems

HIV infection can also cause oral health problems that are rare in uninfected people, including:

• Candidiasis. Candidiasis is a fungal infection that HIV patients often get as their CD4+ cell count decreases. One of the most common types associated with HIV, thrush (or pseudomembranous candidiasis), appears as white patches in the mouth or pharynx.
• Periodontal disease. HIV-positive individuals very often have periodontal disease caused by bacterial infections even if they do not have any other symptoms of HIV. At first, the periodontal disease is characterized by the sudden and rapid loss of soft tissue and jaw bone. As the disease progresses, the person may also develop gingivitis with ulcers that leave crater-like crevices after healing.
• Herpes simplex virus. HSV can also cause sores in and around the mouth. Typically, HSV-1 causes ulcers in the mouth and HSV-2 causes genital herpes. However, oral infection with HSV-2 and genital infection with HSV-1 can occur — this infection is usually spread during oral sex. The symptoms of both types are identical.

Kaposi’s sarcoma and shingles can also cause ulcers in the mouth. Kaposi’s sarcoma oral lesions are very similar to the skin lesions. Shingles lesions in the oral tissue may merge into large ulcers instead of crusting over as they do on the skin. Shingles oral ulcers often get into the gum tissue, causing tooth pain.

HIV: Neurological Effects

Although HIV does not appear to infect nerve cells, it does somehow affect their ability to function normally. People with HIV can experience:

• AIDS-related dementia
• A decrease in the ability to think properly and process information
• Brain tumors that either begin in the brain or spread to the brain from elsewhere in the body
• Progressive multifocal leukoencephalopathy (PML), which is caused by a virus most people are already infected with, but does not cause disease in people with healthy immune systems. Symptoms include difficulty walking and talking, weakness in the limbs, and seizures.

Other neurological complications such as headaches, fever, nausea, and dizziness may occur as a result of HIV treatments.

HIV: Weight Effects and Wasting Syndrome

A big concern for people who have HIV that has progressed to AIDS is AIDS wasting syndrome, which is defined as any unintentional weight loss of 10 percent or more of your body weight. HIV patients may lose muscle as well as fat, and once lost, the weight is difficult to regain. The person may also have diarrhea and a slight fever. These symptoms are usually accompanied by a complete loss of appetite. AIDS wasting syndrome is extremely dangerous for HIV-infected people but it can largely be prevented by eating a healthy, nutrient-rich diet (including such foods as peanut butter, eggs, cheeses, and legumes) and regular exercise to maintain muscle mass.

While HIV infection can lead to a variety of very serious complications, advances in treatments have significantly improved the outlook for people with HIV infection. In fact, a study found that only about 10 percent of people with HIV die of one of the conditions that defines AIDS. Since HIV-infected individuals are now living longer, they are more likely to die from other causes.

Oxymetholone reduces wasting among HIV patients.

Oxymetholone, an anabolic steroid, appears to be effective in countering wasting among HIV-positive patients taking highly active antiretroviral therapy (HAART).

This finding results from a double-blind, randomised, placebo-controlled trial at the University of Essen, and the University of Bonn, Germany. Eighty-nine HIV-positive women and men participated.

Chronic involuntary weight loss is a serious problem among patients on HAART. The alterations in energy metabolism and endocrine regulation cause loss of lean body mass (LBM) and body cell mass (BCM).

There has been partial restoration of LBM in studies among HIV-positive men undergoing androgen replacement therapy, or treatment with recombinant growth hormone. However, these treatments have largely been ineffective among eugonadal individuals.

In the present study, the men and women with wasting were given Oxymetholone 50 mg twice (BID), or three times daily (TID), or placebo for 16 weeks, followed by open-label treatment. Endpoints were body weight, bioimpedance measurements, and appetite.

The clinicians found that Oxymetholone produced a significant weight gain of 3.0 ± 0.5 kg in the TID group, and 3.5 ± 0.7 kg in the BID group, while patients in the placebo group gained an average of 1.0 ± 0.7 kg. Body cell mass increased 3.8 ± 0.4 kg in the BID group and 2.1 ± 0.6 kg in the TID group. This corresponded to 12.4T and 7.4% of baseline BCM, respectively.

The patients taking Oxymetholone reported significant improvements in their appetite and food consumption, plus a reduction in feeling weak. The most important adverse event was liver-associated toxicity.

Overall, 35% of patients in the TID, 27% of patients in the BID Oxymetholone group, and no patients in the placebo group, had a greater than five times baseline increase for alanine aminotransferase during the double-blind phase of the study.

Clinicians concluded that “the BID (100 mg/day) regimen appeared to be equally effective as the TID (150 mg/day) regimen in terms of weight gain, LBM and BCM and was associated with less, but still significant liver toxicity.”

Human growth hormone and HIV/AIDS

Human growth hormone (HGH) is a natural hormone produced in the pituitary gland, which promotes normal growth and development in the body. It activates protein production in muscle cells and the release of energy from fats. It is typically used to stimulate growth in children with hormone deficiency, or to treat people with severe illnesses, burns or infection where destruction of human tissue and muscle occurs.

A genetically engineered or ‘recombinant’ version of HGH has been produced (rHGH). Test tube experiments have shown that it can stimulate immune cells such as natural killer (NK) cells, which are related to tumour control and T-cells. rHGH is also known as somatrem or somatotropin. One form of HGH is made by Serono under the brand name Serostim, although other forms are made by other manufacturers. It is given as an injection under the skin.

rHGH is a licensed treatment that can be prescribed on the National Health Service for children with short stature as a result of growth hormone deficiency. However, it is not licensed for prescribing to people with HIV in Europe. rHGH is also very expensive to produce, casting doubt on the feasibility of its introduction into routine HIV care.

There has been some concern that the use of human growth hormone in people with HIV would stimulate viral replication and lead to increased viral load. However, recent evidence suggests that individuals who add growth hormone to their anti-HIV combination are likely to experience a small drop in viral load.

In HIV disease, HGH is best known as a treatment for HIV-related wasting, although it is not an approved treatment for this condition in Europe. High doses of HGH have been found to increase weight and lean body mass in people with AIDS wasting.  An increase in lean body mass is thought to be important in HIV disease because the loss of lean body mass is the form of wasting most closely related to an increased risk of death.

In August 1996, HGH was granted accelerated approval in the United States for the treatment of AIDS wasting. Studies of up to twelve weeks in duration have found that the drug may stabilise weight or reverse weight loss in people with HIV, although no improvements in survival were seen. The long-term safety and tolerability of HGH are unknown. In the European Union, HGH has been granted orphan drug status for the treatment of AIDS wasting, which means that Serono will have exclusive rights to market the product for this purpose in Europe, even though other companies also have their own versions of the treatment.

In a recent meta-analysis of treatments for wasting, rHGH was found to have similar efficacy to the other two major treatments, testosterone and anabolic steroids, with all three showing a significant benefit over placebo. However, rHGH may have advantages in terms of increasing muscle function and quality of life.

Clinical studies, including two randomised trials, have confirmed that HGH can reduce abdominal fat and increase muscle mass in people taking anti-HIV treatment. These improvements in body composition are paralleled by increases oxygen uptake, the ability to carry out moderate physical exercise, and the capacity for high-intensity exercise.

Reductions in ‘buffalo hump’ and breast size have also been reported, although breast development in men has been noted as a side-effect of rHGH. Improvements may reverse on stopping rHGH and may be more likely among individuals with mild body fat abnormalities.

The benefits of rHGH seem to be limited to boosting muscle and decreasing fat accumulation. It has no effect on fat loss in the face and limbs.

In addition to its possible beneficial effects on wasting and fat redistribution, recent studies have suggested that rHGH may improve CD4 cell counts in patients on antiretroviral therapy. In one randomised study addition of 1.5mg rHGH daily to antiretroviral therapy for 48 weeks increased CD4 cell counts by a median of 55 cells/mm3, while a shorter course of 3mg daily for 24 weeks improved CD4 cell counts by the same amount. Around half of this increase was in naive CD4 T-cells and it was coupled with an increase in the size and function of the thymus gland, the organ under the breastbone that produces new naive T-cells.

Further research is needed to establish whether these effects are paralleled by an improved ability to fight infection.

Side-effects of HGH can include headache, muscle pain, joint pain, salt and water retention and rare instances of carpal tunnel syndrome (pain or tingling in the first three or four fingers of the hand). Children treated with the drug over the long term develop antibodies to it, but these do not seem to have any harmful effects.

A large-scale study of rHGH in people with AIDS wasting identified several serious side-effects which were thought to be associated with rHGH. These included skin cancers, gastrointestinal bleeding, inflammation of the arteries, and breast development in men. Elevated triglycerides and the development of diabetes have also been reported among individuals taking rHGH with antiretroviral therapy-related body fat changes. In a randomised study of several HGH doses to treat AIDS wasting, glucose levels rose modestly in 28% of patients receiving a daily dose and 18% of patients receiving doses on alternate days. There was one case of new onset diabetes and two cases of hyperglycaemia amongst the 646 patients who received HGH for up to 24 weeks.

The Effects of Oxandralone on Body Weight and Composition in Patients with HIV-Associated Weight Loss

A variety of anabolic steroids are in use to help counteract the severe loss of body weight that effects many patients with advanced HIV disease. Studies have previously shown that HIV-related wasting causes the destruction of body cell mass (or BCM: active muscle and tissue) while leaving fat stores relatively untouched, so treatments that preserve or help regain healthy, active body tissue are obviously important.

This open-label observational study enrolled 572 patients (527 men and 45 women) with a mean age of 40 years and a mean baseline weight of 68.1 kilograms. Patients were on stable antiretroviral regimens, had documented weight loss, and had no active opportunistic infections or cancers. All patients were treated daily with 20 mg of oxandrolone, an anabolic steroid in pill form. Study visits were scheduled after 1, 2, 4, 8 and 12 months. At each visit, patients were weighed, asked to assess their appetite, sense of well-being, and energy levels, and underwent bioelectric impedance assay (BIA) analysis. BIA measures body cell mass, amount of water in the body, and fat vs. muscle ratio.

Only 26 of the 572 patients had completed the full year-long study before Geneva, but their results, and the interim results from other the patients, were promising. Among the first 26, mean increases in total body weight (and body cell mass, listed in parentheses) were as follows:

• Month 1 2.4 kg total (1.4 kg of which was BCM)
• Month 2 2.8 kg (1.5 kg)
• Month 4 4.4 kg (2.1 kg)
• Month 8 5.4 kg (3.1 kg)
• Month 12 6.1 kg (3.5 kg) 

Patients' self-assessment also improved, with increased appetite and sense of well-being, and oxandralone was generally well-tolerated, with fewer than one percent of patients experiencing liver function test abnormalities, a side effect associated with anabolic steroids. Most side effects were managed with dose reductions. 

Anabolic steroids help AIDS patients

My hope is by sharing my story (which I’ve told to only a few friends) you also might be encouraged to document and share your own story about AIDS. It is our stories that are the heart and soul of the history of AIDS.  None should be forgotten. Ever.

It was in 1988 that a friend of mine introduced me to Dr. Walter Jekot, an HIV doctor practicing in Los Angeles. Dr. Jekot knew I was semi-retired at 24 and asked if I’d consult with him to help market his sports medicine practice in West Hollywood. The bulk of his patients were gay men, mostly bodybuilders and a few athletes. Why not, I thought. Partying every night was starting to get kind of boring anyway.

One Saturday afternoon, a couple of months into working with Dr. Jekot, two men wearing suits came into his office and closed the door. They stayed for more than three hours. After they left, I went in to ask Dr. Jekot what was going on. As I asked my first question, he just looked up and stared at me. He was ghost white. “What’s wrong,” I asked. “Sit down, Dave,” he replied. “There is something I have to tell you.”

He said the men were his attorneys. “I am being prosecuted by the federal government for what they say is the illegal distribution of anabolic steroids and growth hormone,” he explained. Then he told me his story.

After the 1988 Olympics in Los Angeles, scandal hit the sports world. Ben Johnson, a Canadian sprinter and gold medal winner that year, was to appear at a court hearing that would be broadcast live around the world. The government wanted to find out if Johnson could be prosecuted for cheating because he allegedly took anabolic steroids during the 1988 Olympic Games. During the trial, Johnson’s doctor said that Dr. Jekot had dispensed anabolic steroids to the U.S. Olympic athletes during the same Olympic Games.

Within 15 minutes every news agency in the world was beating down Dr. Jekot’s door, trying to get a comment, demanding an interview. A week later, the assistant attorney general of the United States announced on live television that the Department of Justice was going after Dr. Jekot with every legal resource available to the federal government.

I sat there stunned. I felt betrayed. I got up and started to leave, but he blocked the door. “Wait,” he asked.  “There is something else.”

First, he apologized for not telling me sooner. He said he was scared and didn’t know whom he could trust, including his own attorneys. “Did you do it,” I asked. When he said no, I sat down again.

He wanted to tell me something, he said, about a discovery he made, but I had to promise not to tell anyone else. I declined.  He told me anyway:  “I have discovered that anabolic steroids and growth hormones can help AIDS patients by reversing the wasting process.”

Wasting is the involuntary loss of body weight the entire gay community had seen time and again.

Having a sports management background, I had spent years warning our athletes about the ills of steroids. I was skeptical. In fact, I didn’t believe him. Why should I?  But some strange force kept me in that chair listening. I wanted to know more about the discovery that might help AIDS patients.

A month later I asked for and received written permission to have access to the medical records of 13 AIDS patients who were being treated with anabolic steroids or growth hormones for AIDS-related wasting. I also asked to be permitted to interview each patient. All agreed.

It was 1989. After sitting down with each of the 13 patients, I became convinced anabolic steroid treatments worked. I had no idea why or how, but something was keeping these patients alive. They had energy and looked healthy and fit.

Thus began my quest to have the most unpopular and denounced drug in the world become accepted as the therapy to reverse wasting syndrome and bring people back to life. I believe this was, in fact, the first Lazarus Effect treatment. Within three years, anabolic steroids became standard treatment to reverse AIDS-related wasting.

For some, steroid use builds hope

A few years after his HIV diagnosis, Nelson Vergel began wasting away. No matter how much he ate, no matter how many protein shakes he added to his diet, no matter how much iron he pumped, the chemical engineer could not regain 25 pounds the virus had stripped from his 5-foot-7 frame. He watched as dozens of HIV-infected friends progressively lost body fat and muscle, and, ultimately, their lives. "Either I have to do something," Vergel thought, "or I'll be the next one." Then he found anabolic steroids.

For more than a decade, Vergel has been among the chronically ill patients who take anabolic steroids - legally - for the same fundamental reason some athletes use them on the sly: to build up their bodies. A storm of attention has been paid of late to illicit use of steroids among athletes, who forever want to run faster and hit balls farther. But at the same time, a quiet movement is under way to discover what legitimate role the drugs can play in mainstream medicine.

For years, doctors have prescribed anabolic steroids for those with HIV or AIDS, kidney disease, cancer and other illnesses that cause malnutrition or muscle wasting that can leave patients dangerously thin. And, although the long-term side effects of anabolics aren't fully known, even at low doses, some physicians see definite therapeutic benefits.

"Not only do they help rebuild muscle, they make you feel better," said Dr. Bruce Rashbaum, a Washington internist who has prescribed anabolic steroids to HIV and AIDS patients for 15 years. "It's not as if these patients are going to become Hercules, because they aren't going to be."

Not all doctors think the benefits of prescribing anabolic steroids for chronic conditions outweigh the potential risks, however. What's more, they say, simply adding muscle to a frail body isn't necessarily going to help someone who is dying from a disease anyway. But given the difficulty physicians have had in helping severely malnourished people gain lean muscle tissue -- as opposed to fat - scientists are continuing to study whether steroids might be among the answers.

Said Rashbaum: "Everyone has this notion that these drugs are taboo, and they don't even entertain the idea of learning about it. I really think in the short and long run the benefit certainly outweighs the risk for those patients that really need them."

In 1999, Dr. Kirsten L. Johansen, director of dialysis at the San Francisco VA Medical Center, led a study of 29 patients with kidney failure. Over six months, they were either injected with an anabolic steroid or given a dummy pill. Those in the drug group gained an average of nearly six pounds more in lean body mass - and reported less fatigue - than those taking the placebo. Johansen has been following up on that research to determine whether the patients' boost in weight was attributable to muscle and whether it translated into better physical function and quality of life.

"We know that people who lose muscle mass tend to die sooner," she said. "But what we really don't know is: If we build muscle mass, are we helping them? These patients are really debilitated. For some of them, that's just such an issue that they really might benefit from this."

Anabolic steroids date to the 1930s, when scientists created a synthetic form of the male hormone Testosterone. They were targeting hypogonadism, a condition in which the testes don't produce enough testosterone for normal growth and sexual function. Soon, researchers discovered that the drug aided the growth of skeletal muscle, too.

But not without a price: Anabolic steroids have been linked to side effects ranging from acne and aggression to cardiovascular disease and liver cancer. This type of steroid, which differs chemically from the corticosteroids commonly used to treat inflammation - is available legally in the United States only by prescription. And athletes typically take doses considerably higher than those prescribed for medical purposes.

Dr. Marc K. Hellerstein, professor of medicine at the University of California, San Francisco, said modest doses of anabolics, combined with weight training -- if patients are well enough to exercise - yield the best result.

He has used that approach for patients with HIV and AIDS. In a 1999 study he led, 22 men lifted weights and received testosterone by injection. Half also took an oral anabolic steroid.
Both groups increased their lean body mass, weight and strength. But those in the steroid group had significantly larger gains. "It was not just cosmetic; this was useful muscle," Hellerstein said. Even at low doses, anabolic steroids can have unpleasant or dangerous side effects, including liver damage and prostate cancer, and doctors who prescribe them have to monitor their patients closely.

In Hellerstein's study, those side effects included a drop in HDL (the "good" cholesterol), as well as irritability and overly aggressive behavior. In general, some patients don't like steroids because the drugs can cause sleep problems or make them more likely to pick fights with their partners. But others thrive on them.

Dr. Adrian S. Dobs, an endocrinologist at the Johns Hopkins School of Medicine, said she believes there's a limited role for anabolics in medicine, including with HIV and AIDS patients. But in other cases, she says, the long-term risks - which are still unknown - might be too great. "I just don't think there's good data to say it's really worth doing, with the exception of a few disease states," she said. "Increasing muscle mass per se is not a benefit. ... Are you doing any good? What's going on with the underlying disease?"

Vergel, who has been taking anabolic steroids since 1994, credits them with helping him through a difficult period before the advent of effective antiviral treatments that helped reduce chronic wasting. During his first four months injecting anabolics, Vergel put on 35 pounds, enough to push him up to 175, more than he weighed when he was healthy. The 46-year-old, who lives in Houston, kept up with the drug regimen and saw his white blood cell count climb. His energy and appetite improved. "I was looking great," he said. "For the first time, I was looking like I was not HIV-positive. I just felt like a superman. I just thought, 'Maybe I'll survive.'"

Vergel, who still takes a regular course of anti-HIV drugs, weighs 190 pounds and looks like a bodybuilder, founded a nonprofit group called PoWeR - Program for Wellness Restoration.

He eventually left his job and wrote a book outlining a health plan for HIV-positive people based on steroids, exercise and nutrition. Anabolics, he says, are only a part of the equation.
A doctor supervises his use of the drugs, regularly checking for changes in liver function and blood pressure and screening for prostate cancer. "When you're sick, the risk-to-benefit ratio changes in your mind,"

Vergel said. "I have no doubt that my quality of life and my life have been extended."