NCT00065104

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at below P25 for phase_2 hiv-infections

Timeline
Completed

Started Oct 2000

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2000

Completed
2.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2003

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

July 17, 2003

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 18, 2003

Completed
Last Updated

August 18, 2006

Status Verified

August 1, 2006

First QC Date

July 17, 2003

Last Update Submit

August 16, 2006

Conditions

HIV Infections

Keywords

HIVDHEAimmune systemhormonesbody compositionquality of life

Interventions

DHEADRUG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Community Consortium

San Francisco, California, 94110, United States

Location

MeSH Terms

Conditions

HIV Infections

Interventions

Dehydroepiandrosterone

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System Diseases

Intervention Hierarchy (Ancestors)

AndrostenolsAndrostenesAndrostanesSteroidsFused-Ring CompoundsPolycyclic Compounds17-KetosteroidsKetosteroidsAdrenal Cortex HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsTestosterone CongenersGonadal Steroid HormonesGonadal Hormones

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
NIH

Study Record Dates

First Submitted

July 17, 2003

First Posted

July 18, 2003

Study Start

October 1, 2000

Study Completion

April 1, 2003

Last Updated

August 18, 2006

Record last verified: 2006-08

Locations

US(1)