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AIDS Wasting in Women: Anabolic Effects of Testosterone

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ClinicalTrials.gov Identifier: NCT00006158
Recruitment Status : Completed
First Posted : August 9, 2000
Last Update Posted : February 15, 2010
Sponsor:
Information provided by:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Study Description
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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

Study Design
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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

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Arms and Interventions
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Outcome Measures
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Eligibility Criteria
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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes 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
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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 ClinicalTrials.gov identifier (NCT number): NCT00006158


Locations
United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Sponsors and Collaborators
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Investigators
Principal Investigator: Steven Grinspoon, MD Massachusetts General Hospital
More Information
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Publications:

ClinicalTrials.gov Identifier: NCT00006158     History of Changes
Other Study ID Numbers: anabole (completed)
DK54167
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):
AIDS
HIV
weight loss
Wasting Syndrome
 testosterone
androgen levels
hormones

Additional relevant MeSH terms:
Cachexia
Wasting Syndrome
HIV Wasting Syndrome
Emaciation
Weight Loss
Body Weight Changes
Body Weight
Signs and Symptoms
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
Testosterone
Testosterone enanthate
Testosterone undecanoate
Testosterone 17 beta-cypionate
Methyltestosterone
Androgens
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Antineoplastic Agents