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AIDS Wasting in Women: Anabolic Effects of Testosterone

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00006158
Recruitment Status : Completed
First Posted : August 9, 2000
Last Update Posted : February 15, 2010
Information provided by:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
AIDS Wasting Syndrome Drug: Testosterone Phase 2

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Study Type : Interventional  (Clinical Trial)
Masking: None (Open Label)
Primary Purpose: Treatment
Study Start Date : September 1998
Actual Study Completion Date : December 2004

Resource links provided by the National Library of Medicine

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00006158

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United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Sponsors and Collaborators
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
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Principal Investigator: Steven Grinspoon, MD Massachusetts General Hospital
Layout table for additonal information Identifier: NCT00006158    
Other Study ID Numbers: anabole (completed)
First Posted: August 9, 2000    Key Record Dates
Last Update Posted: February 15, 2010
Last Verified: February 2010
Keywords provided by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK):
weight loss
Wasting Syndrome
androgen levels
Additional relevant MeSH terms:
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HIV Wasting Syndrome
Wasting Syndrome
Weight Loss
Body Weight Changes
Body Weight
Metabolic Diseases
Nutrition Disorders
HIV Infections
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs