Dehydroepiandrosterone Effects on HIV-1 Replication

NCT ID: NCT00065104

Last Updated: 2006-08-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2000-10-31

Study Completion Date

2003-04-30

Brief Summary

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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

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Conditions

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HIV Infections

Keywords

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HIV DHEA immune system hormones body composition quality of life

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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DHEA

Intervention Type DRUG

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Center for Complementary and Integrative Health (NCCIH)

NIH

Sponsor Role lead

Locations

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Community Consortium

San Francisco, California, United States

Site Status

Countries

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United States

Other Identifiers

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AbramsD

Identifier Type: -

Identifier Source: secondary_id

R01AT000512-01

Identifier Type: NIH

Identifier Source: org_study_id

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