AIDS Wasting in Women: Anabolic Effects of Testosterone

AIDS Wasting Syndrome Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00006158
• Other study ID #: anabole (completed)
• Secondary ID: DK54167
• Status: Completed
• Phase: Phase 2
• First received: August 8, 2000
• Last updated: February 12, 2010
• Start date: September 1998
• Est. completion date: December 2004

Study information

• Verified date: February 2010
• Source: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Est. completion date: December 2004
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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

Study Design

Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• AIDS Wasting Syndrome
• Cachexia
• HIV Wasting Syndrome

Intervention

Drug:
• Testosterone

Locations

Country	Name	City	State
United States	Massachusetts General Hospital	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Country where clinical trial is conducted

United States, 

References & Publications (2)

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. Review. — View 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. — View Citation