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Dehydroepiandrosterone Effects on HIV-1 Replication

Dehydroepiandrosterone Effects on HIV-1 Replication

Status
Completed
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00065104
Enrollment
40
Registered
2003-07-18
Start date
2000-10-31
Completion date
2003-04-30
Last updated
2006-08-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

HIV Infections

Keywords

HIV, DHEA, immune system, hormones, body composition, quality of life

Brief 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.

Interventions

DRUGDHEA

Sponsors

National Center for Complementary and Integrative Health (NCCIH)
Lead SponsorNIH

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
DOUBLE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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)

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026