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Phase II Randomized Study of Physiologic Testosterone Replacement in Premenopausal, HIV-Positive Women
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Purpose
OBJECTIVES: I. Determine whether physiologic testosterone replacement can increase fat-free mass, therefore contributing to weight maintenance, improved muscle function, and quality of life in HIV-infected women.
II. Examine the mechanism of testosterone-induced increase in fat-free mass.
| Condition | Intervention | Phase |
|---|---|---|
| HIV Infections Cachexia | Drug: testosterone | Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Masking: Double Primary Purpose: Treatment |
| Estimated Enrollment: | 56 |
| Study Start Date: | April 1997 |
| Estimated Study Completion Date: | September 2001 |
PROTOCOL OUTLINE: This is a randomized, double blind, placebo controlled study. Patients are randomized to one of three arms.
Arm I: Patients receive two placebo transdermal patches applied twice a week (every 3-4 days).
Arm II: Patients receive one testosterone transdermal patch and one placebo transdermal patch applied twice a week (every 3-4 days).
Arm III: Patients receive two testosterone transdermal patches applied twice a week (every 3-4 days).
Patients receive 12 weeks of treatment in the absence of adverse reaction or health deterioration. Patients are followed on day 1, every 2 weeks during treatment, and at the end of the recovery period. Quality of life is assessed before treatment begins and at weeks 6 and 12.
Completion date provided represents the completion date of the grant per OOPD records
Eligibility| Ages Eligible for Study: | 18 Years to 50 Years (Adult) |
| Sexes Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
PROTOCOL ENTRY CRITERIA:
--Disease Characteristics--
- Histologically confirmed premenopausal HIV-positive women who have experienced 5-15% weight loss
--Prior/Concurrent Therapy--
- Endocrine therapy: At least 3 months since megestrol At least 3 months since anabolic or androgenic steroids At least 3 months since oral contraceptives At least 3 months since Depo-Provera No concurrent hormone replacement therapy
- Other: Concurrent retroviral or protease inhibitors allowed, dosage must be stable At least 3 months since ketoconazole At least 6 weeks since the initiation of protease inhibitors
--Patient Characteristics--
- Hepatic: No significant liver disease SGOT/SGPT no greater than 3 times upper limit of normal (ULN) Alkaline phosphatase no greater than 3 times ULN Bilirubin no greater than 2 mg/dL No medical complications due to alcohol abuse
- Renal: Not specified
- Cardiovascular: No significant cardiovascular disease No uncontrolled hypertension
- Other: Testosterone level (early morning) less than 30 ng/dL Normal gastrointestinal function as indicated by: Absence of diarrhea Normal D-xylose absorption test No acute opportunistic infections or infectious illness No malignant disease No history of breast cancer No history of endometrial cancer No fever of known or unknown origin No unremitting diarrhea defined as: At least 4 watery stools per day OR More than 4 watery stools recently OR Acute change in stool habit with fever No significant respiratory disease No diabetes No illicit drugs within the past 6 months No history of hyperandrogenic disorders such as: Hirsutism Polycystic ovary disease Not pregnant or lactating
Contacts and LocationsPlease refer to this study by its ClinicalTrials.gov identifier: NCT00004400
| United States, California | |
| Charles R. Drew University of Medicine and Science | |
| Los Angeles, California, United States, 90059 | |
| Los Angeles County Harbor-UCLA Medical Center | |
| Torrance, California, United States, 90509 | |
| United States, Missouri | |
| Washington University School of Medicine | |
| Saint Louis, Missouri, United States, 63110 | |
| Study Chair: | Shalender Bhasin | Charles Drew University of Medicine and Science |
More Information
| ClinicalTrials.gov Identifier: | NCT00004400 History of Changes |
| Other Study ID Numbers: |
199/13251 CDUMS-FDR001397 |
| Study First Received: | October 18, 1999 |
| Last Updated: | March 24, 2015 |
Keywords provided by FDA Office of Orphan Products Development:
|
cachexia disease-related problem/condition human immunodeficiency virus infection immunologic disorders and infectious disorders |
nutrition quality of life rare disease viral infection |
Additional relevant MeSH terms:
|
Infection HIV Infections Cachexia Wasting Syndrome Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Immunologic Deficiency Syndromes Immune System Diseases Emaciation Weight Loss Body Weight Changes |
Body Weight Signs and Symptoms Metabolic Diseases Nutrition Disorders 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 |
ClinicalTrials.gov processed this record on September 20, 2017