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Dehydroepiandrosterone Effects on HIV-1 Replication

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00065104
First Posted: July 18, 2003
Last Update Posted: August 18, 2006
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.
Information provided by:
National Center for Complementary and Integrative Health (NCCIH)
  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
Intervention Model: Crossover Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: Dehydroepiandrosterone Effects on HIV-1 Replication

Resource links provided by NLM:


Further study details as provided by National Center for Complementary and Integrative Health (NCCIH):

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

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
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
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


Locations
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 )
AbramsD
First Submitted: July 17, 2003
First Posted: July 18, 2003
Last Update Posted: August 18, 2006
Last Verified: August 2006

Keywords provided by National Center for Complementary and Integrative Health (NCCIH):
HIV
DHEA
immune system
hormones
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
Dehydroepiandrosterone
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs