AIDS Wasting in Women: Anabolic Effects of Testosterone

The study is a 6 month, placebo-controlled study of transdermal testosterone for women with HIV-associated weight loss. Women with AIDS wasting have been found to have low testosterone levels. This study is designed to test the efficacy of physiologic testosterone dosing to improve weight, muscle mass and quality of life indices, including energy level, appetite and libido, in androgen deficient women with AIDS wasting. After 6 months, all women receive open label transdermal testosterone for an additional 6 months.

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Key information

Conditions

AIDS Wasting Syndrome Acquired Immunodeficiency Syndrome Blood-Borne Infections Body Weight Body Weight Changes Communicable Diseases Genital Diseases HIV Infections HIV Wasting Syndrome Immune System Diseases Immunologic Deficiency Syndromes Infections Lentivirus Infections Metabolic Diseases Nutrition Disorders Nutritional and Metabolic Diseases Pathological Conditions, Signs and Symptoms RNA Virus Infections Retroviridae Infections Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Signs and Symptoms Slow Virus Diseases Urogenital Diseases Virus Diseases Wasting Syndrome Weight Loss

Age range

18 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2

Primary location

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Females using acceptable form of birth control during study, including barrier contraception or IUD but excluding oral contraceptives or Depo-Provera
Documented HIV infection
Free testosterone level 3.0 pg/mL
Weight < 90% or weight loss > 10% of pre-illness weight

Exclusion criteria

Pregnant or actively seeking pregnancy
Breast feeding
New opportunistic infection diagnosed within 4 weeks of the study
Requiring parenteral nutrition or pharmacologic glucocorticoid therapy
Intractable diarrhea (6 stools/day)
Androgen, estrogen, progestational derivative, or glucocorticoid administration within 3 months of the study, including Megace
New retroviral therapy within 6 weeks of study
SGOT > 5 X normal and/or clinically significant liver disease
Creatinine > 2.0 mg/dL and/or clinically significant renal disease
Hgb < 8.0 g/dL
Active substance abuse or alcoholism

Treatment and study plan

Testosterone

Drug

Sponsors and collaborators

Lead sponsor

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Nih

Registry information

Important dates

Study start: 1998
Study completion: 2004
First posted: Aug 9, 2000
Registry last updated: Feb 15, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed