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Dehydroepiandrosterone Effects on HIV-1 Replication

Primary Purpose

HIV Infections

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
DHEA
Sponsored by
National Center for Complementary and Integrative Health (NCCIH)
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for HIV Infections focused on measuring HIV, DHEA, immune system, hormones, body composition, quality of life

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • Community Consortium

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
July 17, 2003
Last Updated
August 16, 2006
Sponsor
National Center for Complementary and Integrative Health (NCCIH)
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1. Study Identification

Unique Protocol Identification Number
NCT00065104
Brief Title
Dehydroepiandrosterone Effects on HIV-1 Replication
Official Title
Dehydroepiandrosterone Effects on HIV-1 Replication
Study Type
Interventional

2. Study Status

Record Verification Date
August 2006
Overall Recruitment Status
Completed
Study Start Date
October 2000 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
April 2003 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
National Center for Complementary and Integrative Health (NCCIH)

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV Infections
Keywords
HIV, DHEA, immune system, hormones, body composition, quality of life

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Crossover Assignment
Masking
Double
Allocation
Randomized
Enrollment
40 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
DHEA

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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)
Facility Information:
Facility Name
Community Consortium
City
San Francisco
State/Province
California
ZIP/Postal Code
94110
Country
United States

12. IPD Sharing Statement

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Dehydroepiandrosterone Effects on HIV-1 Replication

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