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

NCT00004400 | Completed Phase 2

• 2 other identifiers: 199/13251CDUMS-FDR001397
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 3

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.

Conditions

HIV Infections; Cachexia

Keywords

cachexia; disease-related problem/condition; human immunodeficiency virus infection; immunologic disorders and infectious disorders; nutrition; quality of life; rare disease; viral infection

Interventions

testosterone DRUG

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Charles Drew University of Medicine and Science: lead

Study Sites (3)

Charles R. Drew University of Medicine and Science

Los Angeles, California, 90059, United States

Location

Los Angeles County Harbor-UCLA Medical Center

Torrance, California, 90509, United States

Location

Washington University School of Medicine

St Louis, Missouri, 63110, United States

Location

MeSH Terms

Conditions

HIV Infections; Cachexia; Acquired Immunodeficiency Syndrome; Immune System Diseases; Communicable Diseases; Rare Diseases; Virus Diseases

Interventions

Testosterone

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Weight Loss; Body Weight Changes; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Thinness; Slow Virus Diseases; Disease Attributes; Pathologic Processes

Intervention Hierarchy (Ancestors)

Androstenols; Androstenes; Androstanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Testosterone Congeners; Gonadal Steroid Hormones; Gonadal Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists

Study Officials

• Shalender Bhasin

  Charles Drew University of Medicine and Science

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: October 18, 1999
• First Posted: October 19, 1999
• Study Start: April 1, 1997
• Study Completion: September 1, 2001
• Last Updated: March 25, 2015

Record last verified: 1998-05

Locations

US (3)