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AIDS Wasting in Women: Anabolic Effects of Testosterone

Primary Purpose

AIDS Wasting Syndrome

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Testosterone
Sponsored by
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for AIDS Wasting Syndrome focused on measuring AIDS, HIV, weight loss, Wasting Syndrome, testosterone, androgen levels, hormones

Eligibility Criteria

18 Years - 45 Years (Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Massachusetts General Hospital

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
August 8, 2000
Last Updated
February 12, 2010
Sponsor
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
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1. Study Identification

Unique Protocol Identification Number
NCT00006158
Brief Title
AIDS Wasting in Women: Anabolic Effects of Testosterone
Study Type
Interventional

2. Study Status

Record Verification Date
February 2010
Overall Recruitment Status
Completed
Study Start Date
September 1998 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
December 2004 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
AIDS Wasting Syndrome
Keywords
AIDS, HIV, weight loss, Wasting Syndrome, testosterone, androgen levels, hormones

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Masking
None (Open Label)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Testosterone

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Steven Grinspoon, MD
Organizational Affiliation
Massachusetts General Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
9709937
Citation
Miller K, Corcoran C, Armstrong C, Caramelli K, Anderson E, Cotton D, Basgoz N, Hirschhorn L, Tuomala R, Schoenfeld D, Daugherty C, Mazer N, Grinspoon S. Transdermal testosterone administration in women with acquired immunodeficiency syndrome wasting: a pilot study. J Clin Endocrinol Metab. 1998 Aug;83(8):2717-25. doi: 10.1210/jcem.83.8.5051.
Results Reference
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PubMed Identifier
10352167
Citation
Corcoran C, Grinspoon S. Treatments for wasting in patients with the acquired immunodeficiency syndrome. N Engl J Med. 1999 Jun 3;340(22):1740-50. doi: 10.1056/NEJM199906033402207. No abstract available.
Results Reference
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AIDS Wasting in Women: Anabolic Effects of Testosterone

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