Dehydroepiandrosterone Effects on HIV-1 Replication - Tabular View

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Dehydroepiandrosterone Effects on HIV-1 Replication

This study has been completed.
Information provided by National Center for Complementary and Alternative Medicine (NCCAM)

This Tabular View shows the required WHO registration data elements as marked by ^†

Descriptive Information Fields
Brief Title ^†	Dehydroepiandrosterone Effects on HIV-1 Replication
Official Title ^†	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 ^†	Interventional
Study Design ^†	Treatment, Randomized, Double-Blind, Placebo Control, Crossover Assignment, Safety/Efficacy Study
Primary Outcome Measure ^†
Secondary Outcome Measure ^†
Condition ^†	HIV Infections
Intervention ^†	Drug: DHEA
MEDLINE PMIDs
Links

Recruitment Information Fields
Recruitment Status ^†	Completed
Enrollment ^†	40
Start Date ^†	October 2000
Completion Date	April 2003
Eligibility 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)
Gender	Both
Ages	18 Years and older
Accepts Healthy Volunteers	No
Contacts ^††
Location Countries ^†	United States

Administrative Information Fields
NCT ID ^†	NCT00065104
Organization ID	R01 AT000512-01
Secondary IDs ^††	AbramsD
Study Sponsor ^†	National Center for Complementary and Alternative Medicine (NCCAM)
Collaborators ^††
Investigators ^†
Information Provided By	National Center for Complementary and Alternative Medicine (NCCAM)
Verification Date	August 2006
First Received Date ^†	July 17, 2003
Last Updated Date	August 16, 2006

^† Required WHO trial registration data element.
^†† WHO trial registration data element that is required only if it exists.