Dehydroepiandrosterone Effects on HIV-1 Replication

National Institutes of Health (NIH)

Status and phase

Completed

Phase 2

Conditions

HIV Infections

Treatments

Drug: DHEA

Study type

Interventional

Funder types

NIH

Identifiers

NCT00065104

AbramsD

R01AT000512-01

Details and patient eligibility

About

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.

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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)