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NCT00050089 · ClinicalTrials.gov registry record · NA
CSP #512 - Options in Management With Anti-Retrovirals
A NA study of HIV Infections and AIDS, sponsored by US Department of Veterans Affairs.
- Completed
- Registry status
- NA
- Development phase
- 368
- Enrollment target
- 20
- Study locations
NCT00050089 is a NA study of HIV Infections and AIDS that has completed, run by US Department of Veterans Affairs. The registered enrollment target is 368 participants, below the 445-participant average among 542 other HIV Infections trials with a reported enrollment target (17% lower). The trial reports 20 study locations across 12 states.
The verdict
NCT00050089, a NA study of HIV Infections and AIDS, has completed, sponsored by US Department of Veterans Affairs.
- COMPLETED
- Registry status
- NA
- Development phase
- 368 participants
- Enrollment target
- 20
- Study locations
Study Summary
This 'pragmatic' trial is a 2X2 open randomized study of patients in advanced HIV disease who have failed on conventional Highly Active Antiretroviral Therapy (HAART) regimens including all three classes of anti-HIV drugs. The first randomization will allocate patients to an intended 3-month antiretroviral drug-free period (ARDFP) or No ARDFP. The second randomization will allocate patients to Mega-ART (5+ drugs) or to Standard-ART (up to 4 drugs). The total study duration is 6.5 years with 5 years of intake and 1.5 year (minimum) of follow-up; median duration of patient follow-up is about 4 years. The target sample size is 390 patients and will provide 75% power to detect a 30% reduction in the hazard rate for the primary endpoint with mega-ART. Sixty-four sites will be participating in the trial--24 VA, 19 UK and 21 Canada.
Conditions Studied
Interventions
- OTHER No Antiretroviral Drug-Free Period (No ARDFP) vs ARDFP
- DRUG Standard ART vs Mega ART
Study Locations (20)
California
- VA Medical Center, Long Beach - Long Beach
- VA Palo Alto Health Care System - Palo Alto
- VA San Diego Healthcare System, San Diego - San Diego
- VA Greater Los Angeles Healthcare System, West LA - West Los Angeles
Florida
- North Florida/South Georgia Veterans Health System - Gainesville
- VA Medical Center, Miami - Miami
- Bay Pines VAMC (111J) - St. Petersburg
- West Palm Beach VA Medical Center - West Palm Beach
Illinois
- Jesse Brown VAMC (WestSide Division) - Chicago
- Edward Hines, Jr. VA Hospital - Hines
New York
- New York Harbor HCS - New York
- VA Medical Center, Bronx - The Bronx
Arizona
- Carl T. Hayden VA Medical Center - Phoenix
Connecticut
- VA Connecticut Health Care System (West Haven) - West Haven
District of Columbia
- VA Medical Center, DC - Washington D.C.
Georgia
- Atlanta VA Medical and Rehab Center, Decatur - Decatur
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 368 participants |
| Start Date | 2001-01 |
| Est. Completion | 2007-12 |
| Phase | NA |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00050089
The ClinicalTrials.gov registry entry for NCT00050089 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 368 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 445-participant average among 542 other HIV Infections trials with a reported enrollment target (17% lower). The listed sponsor is US Department of Veterans Affairs, which has 632 total studies on file at ClinicalTrials.gov.
The record links to 2 conditions, with HIV Infections appearing as the primary indexed condition, and to 2 interventions - of which No Antiretroviral Drug-Free Period (No ARDFP) vs ARDFP is the first listed.
NCT00050089 reports 20 study locations spanning 12 distinct geographic areas - top geographies include California, Florida, Illinois.
Frequently Asked Questions
What is clinical trial NCT00050089 about?
NCT00050089 is a clinical study titled "CSP #512 - Options in Management With Anti-Retrovirals". This 'pragmatic' trial is a 2X2 open randomized study of patients in advanced HIV disease who have failed on conventional Highly Active Antiretroviral Therapy (HAART) regimens including all three classes of anti-HIV drugs. The first randomization will allocate patients to an intended 3-month antiret...
What is the current status of trial NCT00050089?
This trial is currently completed. It is a NA study. The enrollment target is 368 participants. The study started on 2001-01. Estimated completion is 2007-12.
What conditions does trial NCT00050089 study?
This clinical trial studies the following conditions: HIV Infections, AIDS.
What interventions are being tested in trial NCT00050089?
The interventions under investigation include: No Antiretroviral Drug-Free Period (No ARDFP) vs ARDFP (OTHER), Standard ART vs Mega ART (DRUG).
Who is sponsoring clinical trial NCT00050089?
This trial is sponsored by US Department of Veterans Affairs, which has 632 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00050089 being conducted?
This trial has 20 study locations across Arizona, California, Connecticut, District of Columbia, Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.