Dehydroepiandrosterone Effects on HIV-1 Replication

Completed · Phase 2

Conditions studied: HIV Infections

In brief

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.

Key facts

Study ID

NCT00065104

Run by

National Center for Complementary and Integrative Health (NCCIH)

People needed

40

Starts

2000-10-01

Expected to finish

2003-04-01

Last updated by the study team

2006-08-18

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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)

You may not qualify if…

• 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)

Where it is running

• Community Consortium — San Francisco, California, United States

Full record on ClinicalTrials.gov

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