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Dehydroepiandrosterone Effects on HIV-1 Replication

This study has been completed.
Sponsor:
Information provided by:
National Center for Complementary and Alternative Medicine (NCCAM)
ClinicalTrials.gov Identifier:
NCT00065104
First received: July 17, 2003
Last updated: August 16, 2006
Last verified: August 2006
History of Changes
  Purpose

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.


Condition Intervention Phase
HIV Infections
 Drug: DHEA
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: Dehydroepiandrosterone Effects on HIV-1 Replication

Resource links provided by NLM:

MedlinePlus related topics: HIV/AIDS
Drug Information available for: Prasterone
U.S. FDA Resources

Further study details as provided by National Center for Complementary and Alternative Medicine (NCCAM):

Estimated Enrollment: 40
Study Start Date: October 2000
Estimated Study Completion Date: April 2003
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00065104

Locations
United States, California
Community Consortium
San Francisco, California, United States, 94110
Sponsors and Collaborators
National Center for Complementary and Alternative Medicine (NCCAM)
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00065104     History of Changes
Other Study ID Numbers: R01 AT000512-01, AbramsD
Study First Received: July 17, 2003
Last Updated: August 16, 2006
Health Authority: United States: Food and Drug Administration

Keywords provided by National Center for Complementary and Alternative Medicine (NCCAM):
HIV
DHEA
immune system
 hormones
body composition
quality of life

Additional relevant MeSH terms:
HIV Infections
Acquired Immunodeficiency Syndrome
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
 Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases
Dehydroepiandrosterone
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 23, 2013