Gold J, Phanuphak P, Castelo A; Australasian Society for HIV Medicine. Conference.
Annu Conf Australas Soc HIV Med. 1999 Dec 9-11; 11: 153 (abstract no. P55).
Albion Street Centre, Surry Hills, Sydney.
Objective: To determine the safety and efficacy of nandrolone decanoate, at different dose levels, compared with placebo in a group of HIV positive men with HIV wasting. Design: the study was a 24 week, double-blind, randomised, placebo-controlled, dose-ranging outpatient intervention. Methods: HIV-seropositive patients with CD4 T cell counts below 500/microliter and weight loss of 5-20% of usual body weight were randomised in a double-blind manner to receive 50mg, 100mg, 150mg of nandrolone decanonate or placebo by deep intramuscular injection every 2 weeks for 24 weeks. Outcome variables included weight, body mass index, body composition, a quality of life questionnaire (MOS-SF30). Body composition was assessed using the bioelectrical impedance machine and by anthropometry, which was conducted in each centre by trained operators. Comprehensive laboratory investigations were conducted to assess safety parameters. Results: Ninety-one patients were recruited. The median CD4 T cell count was 50/microliter (range 0-350/microliter). Of these, 79 (87%) completed 12 weeks of therapy and 49 (54%) completed 24 weeks. Subjects were evenly distributed across all treatment and placebo groups. Analysis of the first three months showed a significant improvement in weight (p=0.004) and BMI (p=0.006) in the 150mg treated group and a significant tend to improvement across all treatment groups (p=0.002) compared with placebo. There were also significant improvements in lean body mass in the 100mg and 150mg treated groups, as well as in total body water. There was no change in fat mass across groups. There was no significant difference between groups in terms of side effects. Conclusions: For patients, who have moderate to severe HIV wasting, treatment with nandrolone decanoate at a dose of 150mg each 2 weeks for 12 weeks, when compared with placebo, results in significant improvement in weight, BMI, and lean body mass. Nandrolone decanoate is a low cost and convenient agent to use in patients with HIV wasting and one that has no demonstrable side effects.
Publication Types:
Keywords:
- AIDS Vaccines
- Acquired Immunodeficiency Syndrome
- Anthropometry
- Blindness
- Body Composition
- Body Mass Index
- Body Weight
- Brazil
- CD4 Lymphocyte Count
- Clinical Trials as Topic
- Double-Blind Method
- HIV Infections
- HIV Seropositivity
- Humans
- Male
- Nandrolone
- Nutritional Status
- Placebos
- Thailand
- Weight Loss
- nandrolone decanoate
Other ID:
UI: 102242841
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