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Clinical Trials/NCT00065104
NCT00065104CompletedPhase 2

Dehydroepiandrosterone Effects on HIV-1 Replication

National Center for Complementary and Integrative Health (NCCIH)1 site in 1 country40 target enrollmentStarted: October 1, 2000Last updated:
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Conditions
Drugs

Trial Snapshot

Phase
Phase 2
Status
Completed
Enrollment
40
Locations
1
Study OverviewStudy DesignEligibility CriteriaInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Crossover
Primary Purpose
Treatment
Masking
Double

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts 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)

Investigators

Sponsor Class
Nih

Study Sites (1)

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