Dehydroepiandrosterone Effects on HIV-1 Replication - Tabular View

Tracking Information
First Received Date ^ICMJE	July 17, 2003
Last Updated Date	August 16, 2006
Start Date ^ICMJE	October 2000
Primary Completion Date
Current Primary Outcome Measures ^ICMJE
Original Primary Outcome Measures ^ICMJE
Change History	Complete list of historical versions of study NCT00065104 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE
Original Secondary Outcome Measures ^ICMJE

Descriptive Information
Brief Title ^ICMJE	Dehydroepiandrosterone Effects on HIV-1 Replication
Official Title ^ICMJE	Dehydroepiandrosterone Effects on HIV-1 Replication
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.
Detailed Description
Study Phase	Phase II
Study Type ^ICMJE	Interventional
Study Design ^ICMJE	Treatment, Randomized, Double-Blind, Placebo Control, Crossover Assignment, Safety/Efficacy Study
Condition ^ICMJE	HIV Infections
Intervention ^ICMJE	Drug: DHEA
Study Arms / Comparison Groups
Publications *
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	40
Completion Date	April 2003
Primary Completion Date
Eligibility Criteria ^ICMJE	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)
Gender	Both
Ages	18 Years and older
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United States

Administrative Information
NCT ID ^ICMJE	NCT00065104
Responsible Party
Study ID Numbers ^ICMJE	R01 AT000512-01, AbramsD
Study Sponsor ^ICMJE	National Center for Complementary and Alternative Medicine (NCCAM)
Collaborators ^ICMJE
Investigators ^ICMJE
Information Provided By	National Center for Complementary and Alternative Medicine (NCCAM)
Verification Date	August 2006
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP