Dehydroepiandrosterone Effects on HIV-1 Replication

This study has been completed.

First Received on July 17, 2003. Last Updated on August 16, 2006 History of Changes

Sponsor:	National Center for Complementary and Alternative Medicine (NCCAM)
Information provided by:	National Center for Complementary and Alternative Medicine (NCCAM)
ClinicalTrials.gov Identifier:	NCT00065104

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 II

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:

Genetics Home Reference related topics: complement factor I deficiency

MedlinePlus related topics: HIV/AIDS

Drug Information available for: Prasterone Dehydroepiandrosterone sulfate

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 February 09, 2012