AIDS Wasting in Women: Anabolic Effects of Testosterone
Information source: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Information obtained from ClinicalTrials.gov on May 08, 2007
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: AIDS Wasting Syndrome
Intervention: Testosterone (Drug)
Phase: Phase 2
Status: Completed
Sponsored by: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) Official(s) and/or principal investigator(s):
Steven Grinspoon, MD, Principal Investigator, Affiliation: Massachusetts General Hospital
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.
Clinical Details
Study design: Interventional, Treatment, Open Label, Placebo Control
Eligibility
Minimum age: 18 Years.
Maximum age: 45 Years.
Gender(s): Female.
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
Locations and Contacts
Massachusetts General Hospital, Boston, Massachusetts 02114, United States
Additional Information
Related publications: 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. 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. No abstract available.
Starting date:
September 1998
Ending date: September 2003
Last updated: June 23, 2005
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