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Dehydroepiandrosterone Effects on HIV-1 Replication

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00065104
Recruitment Status : Completed
First Posted : July 18, 2003
Last Update Posted : August 18, 2006
Information provided by:

Study Description
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.

Condition or disease Intervention/treatment Phase
HIV Infections Drug: DHEA Phase 2

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: Dehydroepiandrosterone Effects on HIV-1 Replication
Study Start Date : October 2000
Estimated Study Completion Date : April 2003

Resource links provided by the National Library of Medicine

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

Arms and Interventions

Outcome Measures

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   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)
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00065104

United States, California
Community Consortium
San Francisco, California, United States, 94110
Sponsors and Collaborators
National Center for Complementary and Integrative Health (NCCIH)
More Information

ClinicalTrials.gov Identifier: NCT00065104     History of Changes
Other Study ID Numbers: R01AT000512-01 ( U.S. NIH Grant/Contract )
First Posted: July 18, 2003    Key Record Dates
Last Update Posted: August 18, 2006
Last Verified: August 2006

Keywords provided by National Center for Complementary and Integrative Health (NCCIH):
immune system
body composition
quality of life

Additional relevant MeSH terms:
HIV Infections
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs