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

July 17, 2003
August 16, 2006
October 2000
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Complete list of historical versions of study NCT00065104 on ClinicalTrials.gov Archive Site
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Dehydroepiandrosterone Effects on HIV-1 Replication
Dehydroepiandrosterone Effects on HIV-1 Replication

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.

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double-Blind
Primary Purpose: Treatment
HIV Infections
Drug: DHEA
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
40
April 2003
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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)
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00065104
R01 AT000512-01, AbramsD
Not Provided
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National Center for Complementary and Alternative Medicine (NCCAM)
Not Provided
Not Provided
National Center for Complementary and Alternative Medicine (NCCAM)
August 2006

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP