AIDS Wasting in Women: Anabolic Effects of Testosterone

This study has been completed.
Sponsor:
Information provided by:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
ClinicalTrials.gov Identifier:
NCT00006158
First received: August 8, 2000
Last updated: February 12, 2010
Last verified: February 2010
  Purpose

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 Intervention Phase
AIDS Wasting Syndrome
Drug: Testosterone
Phase 2

Study Type: Interventional
Study Design: Masking: Open Label
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK):

Study Start Date: September 1998
Study Completion Date: December 2004
  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00006158

Locations
United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Sponsors and Collaborators
Investigators
Principal Investigator: Steven Grinspoon, MD Massachusetts General Hospital
  More Information

Publications:
ClinicalTrials.gov Identifier: NCT00006158     History of Changes
Other Study ID Numbers: anabole (completed), DK54167
Study First Received: August 8, 2000
Last Updated: February 12, 2010
Health Authority: United States: Federal Government

Keywords provided by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK):
AIDS
HIV
weight loss
Wasting Syndrome
testosterone
androgen levels
hormones

Additional relevant MeSH terms:
Acquired Immunodeficiency Syndrome
Cachexia
Wasting Syndrome
HIV Wasting Syndrome
HIV Infections
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Slow Virus Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Emaciation
Weight Loss
Body Weight Changes
Body Weight
Signs and Symptoms
Metabolic Diseases
Nutrition Disorders
Testosterone
Testosterone enanthate
Testosterone undecanoate
Testosterone 17 beta-cypionate
Methyltestosterone
Androgens
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on September 11, 2014