Phase II Randomized Study of Physiologic Testosterone Replacement in Premenopausal, HIV-Positive Women

• ClinicalTrials.gov Identifier: NCT00004400
• Recruitment Status: Completed
• First Posted: October 19, 1999
• Last Update Posted: March 25, 2015
• Sponsor: Charles Drew University of Medicine and Science
• Information provided by: FDA Office of Orphan Products Development

Study Description

Brief Summary:

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 or disease	Intervention/treatment	Phase
HIV Infections; Cachexia	Drug: testosterone	Phase 2

Detailed Description:

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

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 56 participants
• Allocation: Randomized
• Masking: Double
• Primary Purpose: Treatment
• Study Start Date: April 1997
• Study Completion Date: September 2001

Arms and Interventions

Outcome Measures

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 50 Years (Adult)
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

Criteria

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 Locations

Locations

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

Sponsors and Collaborators

Charles Drew University of Medicine and Science

Investigators

• Study Chair: Shalender Bhasin; Charles Drew University of Medicine and Science

More Information

• ClinicalTrials.gov Identifier: NCT00004400
• Other Study ID Numbers: 199/13251; CDUMS-FDR001397
• First Posted: October 19, 1999
• Last Update Posted: March 25, 2015
• Last Verified: May 1998

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:

Infections; Wasting Syndrome; Cachexia; Emaciation; Weight Loss; Body Weight Changes; Body Weight; Metabolic Diseases; Nutrition Disorders; Testosterone; Androgens; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Physiological Effects of Drugs