Dehydroepiandrosterone Effects on HIV-1 Replication - Full Text View

Dehydroepiandrosterone Effects on HIV-1 Replication

This study has been completed.

Sponsored by:	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

MedlinePlus related topics:

AIDS

ChemIDplus related topics:

Dehydroepiandrosterone sulfate Prasterone

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Crossover Assignment, Safety/Efficacy Study

Official Title:	Dehydroepiandrosterone Effects on HIV-1 Replication

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

Study ID Numbers:	R01 AT000512-01, AbramsD
First Received:	July 17, 2003
Last Updated:	August 16, 2006
ClinicalTrials.gov Identifier:	NCT00065104
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

Study placed in the following topic categories:

Virus Diseases

Sexually Transmitted Diseases, Viral

HIV Infections

Sexually Transmitted Diseases

Acquired Immunodeficiency Syndrome

Dehydroepiandrosterone

Quality of Life

Retroviridae Infections

Immunologic Deficiency Syndromes

Additional relevant MeSH terms:

RNA Virus Infections

Slow Virus Diseases

Immunologic Factors

Immune System Diseases

Physiological Effects of Drugs

Adjuvants, Immunologic

Lentivirus Infections

Infection

Pharmacologic Actions

ClinicalTrials.gov processed this record on August 28, 2008