Adapted from http://www.thebody.com/gmhc/issues/jun02/deca_durabolin.html by Bob Huff
Over eight studies have shown nandrolone to be effective for increasing lean body mass (LBM) and strength in men and women with HIV. A randomized, placebo controlled trial in 38 women conducted by the AIDS Clinical Trials Group (ACTG) reported significant increases in weight and lean body mass after 12 weeks of nandrolone therapy (100 mg every two weeks). There were no differences between the groups in fat increases or in clinical or laboratory adverse events. Hoarseness, hirsutism, and clitoral enlargement were noted rarely in the treated group.
The drug is approved in the U.S. to treat anemia due to renal insufficiency, however many doctors prescribe the agent "off-label" to HIV patients to stimulate weight gain. Nelson Vergel, an advocate for HIV wellness in Houston, Texas said, "This is the safest and most cost effective anabolic steroid in the world and now we have no manufacturer in the U.S."
Besides its safety and reported efficacy, nandrolone is a relative bargain. Treatment costing $150 a month can result in 12 to 30 pound increases of LBM in a wasting patient within four months, according to Vergel. "Many people are taking this drug in a maintenance regimen to keep the LBM they have gained, and are faced with losing it -- and their weight gains -- if no other source becomes available."
"This is a disaster for many of my patients," said Howard Grossman, a New York City physician with a large HIV practice. "We use nandrolone extensively in patients who have testosterone deficiency and are also losing weight. We've seen better weight gain than with testosterone alone and more accumulation of muscle mass. People feel better. I haven't found any increase in side effects."
A recent study by Wanke et al. reported that as many as 29 percent of people with HIV in the era of HAART are still losing weight or lean body mass, despite undetectable viral loads.
Nandrolone decanoate is especially attractive because of its benign side effects profile compared to alternative steroids. According to Vergel, unlike oral steroids such as Oxandrin and Anadrol, nandrolone does not impact liver function lab markers at the low doses used in HIV -- a crucial issue for many people with overtaxed livers from HAART or HCV. One of the FDA approved products to treat HIV-wasting, Megace (megestrol acetate), tends to produce its weight gain due to increases in fat rather than lean body mass -- and adding fat during AIDS wasting has not been shown to improve survival. Megace, a female sex hormone, has also been associated with side effects such as diabetes, blood clots, impotence and the development of female sex characteristics. Another agent approved to treat HIV wasting, Serostim (recombinant human growth hormone), lacks evidence of benefit beyond 12 weeks and can cost as much as $8,000 a month.
FDA-approved appetite stimulants such as Marinol contain the psychoactive ingredient in marijuana (THC), notes Brenda Lein of Project Inform, and "thus is not a preference for many people with HIV who are in recovery." Also, it's theorized that Marinol may simply owe its ability to increase weight to a side effect of the THC high -- that people get the munchies and tend to eat more. Unfortunately, it's usually junk food that's consumed to satiate the craving.
A compounding pharmacy, Applied Pharmacy, is reported willing to make nandrolone in small quantities as long as raw materials remain available, but this is expected to only provide a temporary supply to those who can benefit from the substance. Although there are other generic makers of the product internationally (easily located on the Internet), this offers little help to U.S. patients. Anabolic steroids and testosterone are designated by the Drug Enforcement Administration (DEA) as class III drugs, which are illegal to import even for personal and medical uses.
Up until four years ago, nandrolone decanoate was available from a generic manufacturer at a cost of about $16 per 200 mg dose. After generic production was halted, Deca Durabolin, the brand name product, was available from Watson at $48 per 200 mg dose. A typical low-dose regimen may prescribe 200 mg per week for twelve weeks in order to produce increased lean body mass. Some activists fear that the price could reach exorbitant levels when and if the product is reintroduced with an FDA imprimatur for HIV wasting.
Says Vergel: "An economical and safe product like Deca Durabolin needs to stay in the market at the current pricing levels. FDA approval for wasting could mean that more third party payers could cover its cost, but we should not tolerate any increase due to the 'AIDS cash cow effect'."
San Francisco AIDS activist Mike Donneley said, "Many activists will think that this isn't a fight for us, but I know I finally had the energy to go back to work when I started taking very low-dose Deca. It made all the difference in the quality of my life."
A nationwide network of activists is swinging into action around this issue. Vergel says, "I feel very strongly that "quality of life" drugs need as much advocacy efforts as antivirals, especially in this era."
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This is a summary of all studies in the past that have researched the role of nandrolone in men and women living with HIV:
http://www.medibolics.com/EffectsOfNandroloneStudybyGold.html
Effects of nandrolone decanoate compared with placebo
or testosterone on HIV-associated wasting
"...This study is the first large multicentre randomized placebo-controlled study to demonstrate the effectiveness of nandrolone decanoate over placebo in increasing fat free mass, weight and body mass index in HIV-positive males with wasting. In addition, fortnightly treatment with 150 mg nandrolone decanoate was superior to fortnightly treatment with 250 mg testosterone for increasing weight, increasing body mass index and (insignificantly) increasing fat-free mass. Subjectively, nandrolone was superior to both placebo and testosterone for improving perception of treatment benefit and recovery from symptoms..."
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Effect of nandrolone decanoate therapy on weight and lean body mass in HIV-infected women with weight loss: a randomized, double-blind, placebo-controlled, multicenter trial.
Mulligan K, Zackin R, Clark RA, Alston-Smith B, Liu T, Sattler FR, Delvers TB, Currier JS; AIDS Clinical Trials Group 329 Study Team; National Institute of Allergy and Infectious Diseases Adult AIDS Clinical Trials Group.
Arch Intern Med. 2005 Mar 14;165(5):578-85.
Division of Endocrinology, San Francisco General Hospital, 1001 Potrero Avenue, Rm. 3501K, San Francisco, CA 94110, USA. kmulligan@sfghgcrc.ucsf.edu
BACKGROUND: Weight loss is associated with accelerated mortality and disease progression in patients with human immunodeficiency virus (HIV) infection. Although studies have examined a variety of anabolic therapies in HIV-infected men, the safety and efficacy of such treatments in women have not been adequately studied. METHODS: In this randomized, double-blind, placebo-controlled, multicenter, phase I/II study, 38 HIV-infected women with documented weight loss of 5% or greater in the preceding year or a body mass index of less than 20 kg/m(2) were randomized to receive nandrolone decanoate (100 mg) or an equivalent volume of placebo every other week by intramuscular injection. Subjects received blinded treatment for 12 weeks, followed by open-label therapy for 12 weeks. Lean body mass and fat (bioelectrical impedance analysis) and weight were measured at baseline and at weeks 6, 12, 18, and 24. Biochemical assessments of safety (hematologic analyses, liver function tests, and sex hormone measurements) were performed at these same time points. Clinical signs and symptoms were monitored biweekly. RESULTS: Subjects randomized to receive nandrolone had significant increases in weight and lean body mass during blinded treatment (4.6 kg [9.0%] and 3.5 kg [8.6%], respectively; P<.001 vs baseline and placebo in each case). Fat mass did not change statistically significantly in either group. Although there were no statistically significant differences between groups in biochemical measures, the number of grade 3 or greater toxicities, or reports of virilizing effects, a full assessment of safety cannot be made in a trial of this size. CONCLUSION: Nandrolone decanoate therapy may prove to be generally safe and beneficial in reversing weight loss and lean tissue loss in women with HIV infection and other chronic catabolic diseases.
****************************************************** http://www.medibolics.com/Metabolic%20effects%20of%20Deca%20Study.pdf
Effects of pharmacological doses of nandrolone decanoate and progressive resistance training in immunodeficient patients infected with human immunodeficiency virus.
Sattler FR, Jaque SV, Schroeder ET, Olson C, Dube MP, Martinez C, Briggs W, Horton R, Azen S. J Clin Endocrinol Metab. 1999 Apr;84(4):1268-76. Department of Medicine, University of Southern California School of Medicine, Los Angeles County-University of Southern California Medical Center, Los Angeles 90033, USA.
This nonplacebo-controlled, open label, randomized study was conducted to test the hypotheses that pharmacological doses of nandrolone decanoate would increase lean body tissue, muscle mass, and strength in immunodeficient human immunodeficiency virus-infected men, and that these effects would be enhanced with progressive resistance training (PRT). Thirty human immunodeficiency virus-positive men with fewer than 400 CD4 lymphocytes/mm3 were randomly assigned to receive weekly injections of nandrolone alone or in combination with supervised PRT at 80% of the one-repetition maximum three times weekly for 12 weeks. Total body weight increased significantly in both groups (3.2 +/- 2.7 and 4.0 +/- 2.0 kg, respectively; P < 0.001), with increases due primarily to augmentation of lean tissue. Lean body mass determined by dual energy x-ray absorptiometry increased significantly more in the PRT group (3.9 +/- 2.3 vs. 5.2 +/- 5.7 kg, respectively; P = 0.03). Body cell mass by bioelectrical impedance analysis increased significantly (P < 0.001) in both groups (2.6 +/- 1.0 vs. 2.9 +/- 0.8 kg), but to a similar magnitude (P = NS). Significant increases in cross-sectional area by magnetic resonance imaging of total thigh muscles (1538 +/- 767 and 1480 +/- 532 mm2), quadriceps (705 +/- 365 and 717 +/- 288 mm2), and hamstrings (842 +/- 409 and 771 +/- 295 mm2) occurred with both treatment strategies (P < 0.001 for the three muscle areas); these increases were similar in both groups (P = NS). By the one-repetition method, strength increased in both upper and lower body exercises, with gains ranging from 10.3-31% in the nandrolone group and from 14.4-53.0% in the PRT group (P < 0.006 with one exception). Gains in strength were of significantly greater magnitude in the PRT group (P < or = 0.005 for all comparisons), even after correction for lean body mass. Thus, pharmacological doses of nandrolone decanoate yielded significant gains in total weight, lean body mass, body cell mass, muscle size, and strength. The increases in lean body mass and muscular strength were significantly augmented with PRT.
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Comment: This study found no difference between 150 mg of nandrolone every two weeks (cost:$ 180 a month) versus 6 mg /day of human growth hormone ( $6000 per month) in the amount that both drugs increased body mass. The huge price difference was not mentioned.
A randomized, placebo-controlled trial of nandrolone decanoate in human immunodeficiency virus-infected men with mild to moderate weight loss with recombinant human growth hormone as active reference treatment.
Storer TW, Woodhouse LJ, Sattler F, Singh AB, Schroeder ET, Beck K, Padero M, Mac P, Yarasheski KE, Geurts P, Willemsen A, Harms MK, Bhasin S. J Clin Endocrinol Metab. 2005 Aug;90(8):4474-82. Epub 2005 May 24. Division of Endocrinology, Metabolism, and Molecular Medicine, Charles R. Drew University of Medicine and Science, Los Angeles, California 90059, USA. tstorer@elcamino.edu
OBJECTIVE: We compared the effectiveness of a biweekly regimen of 150 mg nandrolone with placebo in HIV-infected men with mild to moderate weight loss and contrasted its effects against a Food and Drug Administration-approved regimen of recombinant human (rh)GH. METHODS: In this placebo-controlled, randomized, 12-wk trial, placebo and nandrolone (150 mg im biweekly) were administered double blind, and rhGH (6 mg sc daily) was administered in an open-label manner. Participants were HIV-infected men with 5-15% weight loss over 6 months and on stable antiretroviral therapy for more than 12 wk. Lean body mass (LBM), muscle performance, physical function, endurance, hormone levels, insulin sensitivity, sexual function, quality of life, and appetite were assessed at baseline and after 12 wk. RESULTS: Nandrolone administration was associated with a greater increase in LBM (+1.6 +/- 0.3 kg) by dual-energy x-ray absorptiometry scan than placebo (+0.4 +/- 0.3 kg; P < 0.05); however, the change in LBMs with nandrolone was not significantly different from rhGH (+2.5 +/- 0.3 kg). Nandrolone administration was also associated with significantly greater gains in fat-free mass (+1.6 +/- 0.3 kg), body cell mass (+1.0 +/- 0.2 kg), and intracellular water (+0.9 +/- 0.2 kg) than placebo; these changes in the nandrolone group were not significantly different from the rhGH group. rhGH administration was associated with greater loss of whole body fat mass and higher frequency of drug-related adverse effects and treatment discontinuations than nandrolone and placebo and a greater increase in extracellular water than nandrolone. Nandrolone treatment was associated with greater improvements in perception of health than rhGH and sexual function than placebo. The cachexia/anorexia scores, health care resource use, and insulin sensitivity did not significantly change. CONCLUSION: We conclude that nandrolone is superior to placebo and not significantly different from a Food and Drug Administration-approved regimen of rhGH in improving lean body mass in HIV-infected men with mild to moderate weight loss
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Effects of pharmacological doses of nandrolone decanoate and progressive resistance training in immunodeficient patients infected with human immunodeficiency virus.
Sattler FR, Jaque SV, Schroeder ET, Olson C, Dube MP, Martinez C, Briggs W, Horton R, Azen S. J Clin Endocrinol Metab. 1999 Apr;84(4):1268-76. Department of Medicine, University of Southern California School of Medicine, Los Angeles County-University of Southern California Medical Center, Los Angeles 90033, USA.
This nonplacebo-controlled, open label, randomized study was conducted to test the hypotheses that pharmacological doses of nandrolone decanoate would increase lean body tissue, muscle mass, and strength in immunodeficient human immunodeficiency virus-infected men, and that these effects would be enhanced with progressive resistance training (PRT). Thirty human immunodeficiency virus-positive men with fewer than 400 CD4 lymphocytes/mm3 were randomly assigned to receive weekly injections of nandrolone alone or in combination with supervised PRT at 80% of the one-repetition maximum three times weekly for 12 weeks. Total body weight increased significantly in both groups (3.2 +/- 2.7 and 4.0 +/- 2.0 kg, respectively; P < 0.001), with increases due primarily to augmentation of lean tissue. Lean body mass determined by dual energy x-ray absorptiometry increased significantly more in the PRT group (3.9 +/- 2.3 vs. 5.2 +/- 5.7 kg, respectively; P = 0.03). Body cell mass by bioelectrical impedance analysis increased significantly (P < 0.001) in both groups (2.6 +/- 1.0 vs. 2.9 +/- 0.8 kg), but to a similar magnitude (P = NS). Significant increases in cross-sectional area by magnetic resonance imaging of total thigh muscles (1538 +/- 767 and 1480 +/- 532 mm2), quadriceps (705 +/- 365 and 717 +/- 288 mm2), and hamstrings (842 +/- 409 and 771 +/- 295 mm2) occurred with both treatment strategies (P < 0.001 for the three muscle areas); these increases were similar in both groups (P = NS). By the one-repetition method, strength increased in both upper and lower body exercises, with gains ranging from 10.3-31% in the nandrolone group and from 14.4-53.0% in the PRT group (P < 0.006 with one exception). Gains in strength were of significantly greater magnitude in the PRT group (P < or = 0.005 for all comparisons), even after correction for lean body mass. Thus, pharmacological doses of nandrolone decanoate yielded significant gains in total weight, lean body mass, body cell mass, muscle size, and strength. The increases in lean body mass and muscular strength were significantly augmented with PRT.
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Effects of nandrolone decanoate therapy in borderline hypogonadal men with HIV-associated weight loss.
Strawford A, Barbieri T, Neese R, Van Loan M, Christiansen M, Hoh R, Sathyan G, Skowronski R, King J, Hellerstein M. J Acquir Immune Defic Syndr Hum Retrovirol. 1999 Feb 1;20(2):137-46. Department of Nutritional Sciences, University of California at Berkeley, 94720, USA.
Serum testosterone concentrations are frequently in the low-normal range (lowest quartile, <500 ng/dl) in men with AIDS-wasting syndrome (AWS) and in other chronic wasting disorders. The response of patients in this group to androgen treatment has not been determined, however. Eighteen men with AWS (mean +/- standard error [SE]: 87% +/- 1% usual body weight; CD4 count 90 +/- 24) and borderline low serum testosterone concentrations (382 +/- 33 ng/dl) completed a 21-day placebo-controlled inpatient metabolic ward study comparing intramuscular (i.m.) placebo (n = 7) with low-dose (65 mg/week; n = 4) and high-dose (200 mg/week; n = 7) nandrolone decanoate, a testosterone analogue. Nitrogen balance, stable isotope-mass spectrometric measurement of de novo lipogenesis (DNL), resting energy expenditure, and gonadal hormone levels were measured. Both low-dose and high-dose nandrolone resulted in significant nitrogen retention (33-52 g nitrogen/14 days, representing gains of 0.5 to 0.9 kg lean tissue/week) compared with placebo (loss of 11 g nitrogen/week). This was reflected biochemically in a borderline significant reduction of high DNL (p < .06). Serum testosterone and gonadotropins were suppressed whereas resting energy expenditure was unchanged by nandrolone treatment. In 10 study subjects completing a 12-week open-label follow-up phase, body weight increased by 4.9 +/- 1.2 kg, including 3.1 +/- 0.5 kg lean body mass, and treadmill exercise performance also improved. In summary, nandrolone decanoate therapy in the absence of an exercise program in borderline hypogonadal men with AWS caused substantial nitrogen retention compared with placebo, similar in extent to the nitrogen retention previously achieved with recombinant growth hormone. It is reasonable to expand the criteria for androgen treatment in AWS to include at least patients in the lowest quartile of serum testosterone.
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Safety and efficacy of nandrolone decanoate for treatment of wasting in patients with HIV infection.
Gold J, High HA, Li Y, Michelmore H, Bodsworth NJ, Finlayson R, Furner VL, Allen BJ, Oliver CJ. AIDS. 1996 Jun;10(7):745-52. Albion Street Centre, Prince of Wales Hospital, Sydney, Australia.
OBJECTIVE: To evaluate the safety and efficacy of the anabolic steroid, nandrolone decanoate (Deca Durabolin) in patients with HIV wasting who are resistant to nutritional intervention. DESIGN: A 16-week open trial with subjects who had lost 5-15% of their usual body weight. SETTING: HIV/AIDS specialist ambulatory care services, both public and private, in sydney, Australia. PARTICIPANTS: Two hundred and twenty men entered the pre-therapy phase, and of these, 24 failed to gain weight and were enrolled. Seventeen subjects (81%) completed the 16-week trial. INTERVENTIONS: Pre-therapy nutritional assessment and education was conducted by the clinical dietitian. Those who failed to gain weight (10.9%) were treated with nandrolone decanoate (100 mg/ml) by deep intramuscular injection every 2 weeks for 16 weeks. MAIN OUTCOME MEASURES: Changes in weight and body composition (lean body mass, total body water and nitrogen index) were measured by anthropometry, bioelectrical impedance, and in vivo neutron activation. Changes in quality of life were assessed by the 30-item Medical Outcomes Study short form questionnaire. Changes in biochemistry, haematology and immunology were also measured. RESULTS: There were significant increases in weight (mean, 0.14 kg per week; P < 0.05) and lean body mass (mean, 3 kg by anthropometry; P < 0.005). The change in lean body mass was of similar magnitude across all measurement modalities. Quality of life parameters, especially functionality, increased significantly during the trial. No subject experienced toxicity. CONCLUSION: Nandrolone decanoate has beneficial effects on weight, lean body mass and quality of life in selected patients who have mild to moderate HIV wasting.
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TESTIMONIALS
http://www.nelsonvergel.com/testimonials.htm
COMPARISON OF ANABOLIC AGENTS FOR HIV WASTING
http://medibolics.com/chart2.htm
COST COMPARISON (year 2000 prices) OF HIV WASTING TREATMENTS
http://medibolics.com/comparison2.htm
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There are alternatives to nandrolone, but how effective or costly are they?:
Megace- progesterone based drug that makes you fat and impotent, causes blot clots, adrenal insufficiency and avascular necrosis. It can increase appetite very well, though.
Oxandrin (oxandrolone)- oral anabolic that may be a good option, but known not to be very effective for moderate to severe wasting. However, at a cost of about $1400 a month for 20 mg a day, it ain't cheap. It can also raise liver enzymes as all oral anabolics that are 17-alpha alkylated. It is included in NY and CA ADAP's but not sure about most other programs. It is approved to treat involuntary weight loss due to illness (not HIV specific). Three studies in HIV
Other oral anabolics (Anadrol and Wistrol)- Available in the US for anemia but most doctors do not prescribe it in HIV due to concerns of liver enzyme increases. Both have two small HIV studies in the past.
Serostim (growth hormone)- $6000 a month for 6 mg a day recommended dose. It works faster than any other agent since it hydrates cells pretty quickly, It can cause joint pains and irreversible diabetes in those with glucose intolerance. ADAP, insurance and Medicaid?Medicare part D access is now restricted after all the mess with Serono's scandal. It is the only drug approved for HIV wasting
Supplements - Juven: included in some ADAPs and shown to be somewhat effective in increasing weight. It is a mixture of amino acids. Last time I checked it runs around $180 a month
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Compounding pharmacies are the only source of nandrolone left in the US, but for how long?
Nandrolone decanoate ( brand name : Deca Durabolin) is an old and cheap generic injectable. It is NOT approved for weight loss or wasting but for anemia. Off label use has been ok for the past 20 years in HIV. However, the DEA pressure on companies that make anabolics is now affecting people with HIV wasting. The only source now left in the US for nandrolone is compounding pharmacies that make it themselves. But the DEA is also trying to shut them down.
Please join me in contacting Congress to stop this legislation and protect patient access to compounded drugs! Visit http://www.savemymedicine.org/ to take action.
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