Nandrolone decanoate combats HIV-related weight loss: results from three randomised studies
Graham McKerrow, HIV i-Base
Three randomised placebo-controlled studies presented in Glasgow demonstrated the usefulness of nandrolone decanoate (ND) in combating weight loss of HIV-positive men.
One found that ND increased body weight in subjects when compared to placebo or testosterone; a second trial found that two higher doses of ND were more effective than a lower dose or placebo; and a third trial concluded that ND was better than placebo but little different from recombinant human growth hormone (rhGH) in its ability to increase lean body mass in the subjects.
ND was found to be well tolerated in all thee studies and there were no dose-related responses observed in quality of life (QoL) or in change of CD4 or CD8 cell counts.
Julian Gold and colleagues in Australia and the Netherlands carried out an international multi-centre double-blind trial comparing ND with placebo and testosterone (TST). 
This study randomised 303 subjects to ND150mg, TST 250mg or placebo fortnightly for 12 weeks. Those treated with ND showed significantly greater increases in fat free mass (FFM) versus those given placebo. Increases in weight were significantly greater with ND than with TST. The researchers found no significant differences in the incidence of adverse events, in immune markers or in HIV viral load.
Chris Duncombe and colleagues of the Netherlands Austria Thailand (NAT) Research Collaboration, report on their multicentre double-blind trial that looked at the effects of treatment with ND 50mg, ND 100mg and ND 150mg or placebo in 91 subjects over 24 weeks. 
The two groups on the higher doses of ND showed a mean increase in LBM compared to placebo. At week 12, those on placebo and those on ND 50mg had lost weight, while the 100mg and 150mg groups of ND showed weight gain of 0.59kg and 0.76kg respectively. QoL was measured using the MOS-SF30 questionnaire and no dose related responses were observed. Dose did not affect CD4 or CD8 cell counts.
Theodorus Geurts and colleagues in the Netherlands and the United States, randomised 85 patients to receive 12 weeks ND 150mg or placebo, fortnightly and double blind, or open label rhGH 6mg daily. 
They noted significantly greater gain in lean body mass after 12 weeks of ND treatment compared to placebo but there was no significant difference between ND and rhGH. There was significantly greater loss of fat mass after rhGH than after ND, and no difference between ND and placebo. FFM, body cell mass and intracellular water were also seen to increase significantly more with ND than placebo. The rhGH group suffered more drug-related adverse events than either of the other two groups.
The first two studies confirm benefits reported anecdotally for many years but it is good to see this confirmed in randomised controlled settings.
The use of 6mg rHGH in the Dutch study, is associated with considerable side effects. Some US practicioners currently recommend <2mg/day rHGH in combination with testosterone replacement and/or oxandrolone.
- Gold J, Batterham M, Helmyr P et al. Nandrolone decanoate compared with placebo and testosterone for HIV associated wasting: a multi-centre international clinical trial. 7th ICDTHI,14-18 Nov, 2004, Glasgow. Abstract PL7-5.
- Duncombe C, Chuenyam T, Geurts P et al. The effects of nandrolone decanoate on weight loss and quality of life in male patients with acquired immunodeficiency syndrome. 7th ICDTHI,14-18 Nov, 2004, Glasgow. Abstract PL7.6.
- Geurts T, Storer T, Woodhouse L et al. Randomised, placebo-controlled trial of nandrolone decanoate in HIV-infected men with mild to moderate weight loss with rhGH as reference treatment. 7th ICDTHI,14-18 Nov, 2004, Glasgow. Abstract P8.