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AIDS Wasting in Women: Anabolic Effects of Testosterone

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00006158
First Posted: August 9, 2000
Last Update Posted: February 15, 2010
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.
Information provided by:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
August 8, 2000
August 9, 2000
February 15, 2010
September 1998
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Complete list of historical versions of study NCT00006158 on ClinicalTrials.gov Archive Site
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AIDS Wasting in Women: Anabolic Effects of Testosterone
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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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Interventional
Phase 2
Masking: None (Open Label)
Primary Purpose: Treatment
AIDS Wasting Syndrome
Drug: Testosterone
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
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December 2004
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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
Sexes Eligible for Study: Female
18 Years to 45 Years   (Adult)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00006158
anabole (completed)
DK54167
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National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
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Principal Investigator: Steven Grinspoon, MD Massachusetts General Hospital
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
February 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP