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.
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.


CONCLUSIONS
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.
Mulligan
Kathleen
K
Division of Endocrinology, San Francisco General Hospital, 1001 Potrero Avenue, Rm. 3501K, San Francisco, CA 94110, USA. kmulligan@sfghgcrc.ucsf.edu
Zackin
Robert
R
Clark
Rebecca A
RA
Alston-Smith
Beverly
B
Liu
Tun
T
Sattler
Fred R
FR
Delvers
Thomas B
TB
Currier
Judith S
JS
D000328:Adult; D045930:Anabolic Agents / Q000627:therapeutic use*; D001774:Blood Chemical Analysis; D015992:Body Mass Index; D001835:Body Weight / Q000187:drug effects; D004311:Double-Blind Method; D005260:Female; D019247:HIV Wasting Syndrome / Q000097:blood / Q000188:drug therapy*; D006403:Hematologic Tests; D006728:Hormones / Q000097:blood; D006801:Humans; D007273:Injections, Intramuscular; D009277:Nandrolone / Q000031:analogs & derivatives* / Q000627:therapeutic use*; D000077603:Nandrolone Decanoate; D009752:Nutritional Status; D015990:Placebo Effect; D012449:Safety; D016896:Treatment Outcome
D045930:Anabolic Agents; D006728:Hormones; D009277:Nandrolone; D000077603:Nandrolone Decanoate