Metabolic and Morphologic Complications of HIV and HAART

Agent (# in study)	Study Length (weeks)	Placebo Controlled	Entry Criteria	Baseline Average Body Weight	Average Weight Gain	Increase In Lean Body Mass	Comment
Serostim® (178) Schambelan	12	Yes	Wt. Loss >10% or Wt. < 90% lower limit IBW	61.7 + 7.9 kg	1.6 (versus 0.1 kg for placebo)	3.0 (versus 0.1 kg for placebo)	Decreases in fat also significant. Treadmill output also increased
Deca Durabolin® (17) Gold	16	No Open label	Wt. Loss of 5-15% of usual body Wt.	62 kg (range: 48-74)	2.3 kg	3.0 kg	QOL also increased
Deca Durabolin® (56) Bucher	12	Yes	HIV+ males	76.5 + 8.7 kg	1.7 + 2.4 kg	NA	LBM not analyzed
Deca Durabolin® (10) Strawford	12	No Open label	HIV wasting, 87% ±1% usual BW and borderline low testosterone	NA	4.9 + 1.2 kg	3.1 ± 0.5 kg	Treadmill exercise also improved
Oxandrin® (10) Romeyn	12	No Pilot study	> 5% Wt. Loss; muscle wasting	NA	2.7 kg. Oxandrin; 3.9 kg. with PRE	NA	Personal trainers not used
Oxandrin® (21) Poles	8	No	>5% usual BW or < 100% IBW at baseline	NA	5.8 kg	3.1 kg (BCM)	Fat and intracellular water increased

• Here you can see a comparison chart of clinical trial results for various anabolic agents used to treat HIV-associated wasting.1-6

• Growth hormone has produced significant increases in lean body mass and treadmill output when investigated in a placebo-controlled trial.1 In addition, significant decreases in fat were also noted.

• Nandrolone decanoate has been studied in 12- and 16-week trials.2-4 Patients with weight loss have regained weight and lean body mass to various degrees.

• Oxandrolone has been studied alone and in combination with progressive resistance exercise.5,6 In both cases, increases in average weight gain were noted.

• Although anabolic steroids may increase lean body mass, their long-term safety and efficacy remain unknown. If they are used at all, the clinician should monitor for side effects and drug-drug interactions. With their risk for hepatotoxicity, they should be avoided altogether in patients with liver disease.

• At this time, neither nandrolone nor oxandrolone has been approved by the FDA for the treatment of AIDS-related cachexia.

References:

1. Schambelan M, Mulligan K, Grundfeld C et al. Recombinant human growth hormone in patients with HIV-associated wasting—a randomized, placebo controlled trial. Ann Intern Med. 1996;125:873-82.

2. Gold J, High HA, Li Y et al. Safety and efficacy of nandrolone decanoate for treatment of wasting in patients with HIV infection. AIDS. 1996;10:745-52.

3. Bucher G, Berger DS, Fields-Gardner C et al. A prospective study on the safety and effect of nandrolone decanoate in HIV-positive patients. Program and abstracts of the XI International Conference on AIDS, Vancouver, British Columbia; July 7-12, 1996. Abstract MoB423.

4. Strawford A, Barbieri T, Neese R et al. Effects of nandrolone decanoate therapy in borderline hypogonadal men with HIV-associated weight loss. J Acquir Immune Defic Syndr Hum Retrovirol. 1999;20:137-46.

5. Poles MA, Meller JA, Linn A et al. Oxandrolone as a treatment for AIDS-related weight loss and wasting. Program and abstracts of the 4th Conference on Retroviruses and Opportunistic Infections; January 22-26, 1997. Abstract 695.

6. Romeyn M, Gunn N III. Resistance exercise and oxandrolone for men with HIV-related weight loss. JAMA. 2000;284:176.