Dehydroepiandrosterone Effects on HIV-1 Replication

• Status: Completed
• Trial end date: 2003-04-01
• Target enrollment: 0
• Participant gender: All

Summary

This study's purpose is to learn how dehydroepiandrosterone (DHEA) affects the HIV virus, the immune system, hormone levels, body composition and quality of life.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: National Center for Complementary and Integrative Health (NCCIH)
• Treatments: Dehydroepiandrosterone

Criteria

Inclusion criteria:

• Evidence of HIV-1 infection

• HIV RNA <50 copies/mL

• Stable antiretroviral treatment regimen for at least 8 weeks

• Age 18 years or older

• Normal pap smear and mammograph within 1 year (females)

• Normal prostate-specific antigen level with in one year, age adjusted (males)

Exclusion criteria:

• Active opportunistic infections or malignancy other than localized cutaneous KS lesions

• Concurrent or prior use within the past 8 weeks of DHA, testosterone, other anabolic steroids, corticosteroids, megestrol acetate, growth hormone, IL-2, or thalidomide

• Diagnosis of AIDS Dementia Complex (stage II or higher)

• Active substance abuse (e.g., alcohol or injection drugs)

• Evidence of severe liver dysfunction or hepatic transaminases greater than 3x the upper normal limit

• Pregnant or breast-feeding

• History of endocrinologically-responsive tumors (e.g., breast, ovarian, uterine, or prostatic cancer, or malignant melanoma)