AIDS Wasting in Women: Anabolic Effects of Testosterone

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Primary Purpose

Status

Completed

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

Testosterone

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

NCT ID

NCT00006158

First Posted

August 8, 2000

Last Updated

February 12, 2010

Sponsor

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

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

background

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

background

AIDS Wasting Syndrome

About this trial

Eligibility Criteria

Sites / Locations

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial