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Dehydroepiandrosterone Effects on HIV-1 Replication

This study has been completed.
Information provided by:
National Center for Complementary and Integrative Health (NCCIH) Identifier:
First received: July 17, 2003
Last updated: August 16, 2006
Last verified: August 2006
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

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: 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 Identifier: NCT00065104     History of Changes
Other Study ID Numbers: R01AT000512-01 ( U.S. NIH Grant/Contract )
Study First Received: July 17, 2003
Last Updated: August 16, 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 processed this record on September 19, 2017