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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: Completed NA study of HIV Infections and AIDS, sponsored by US Department of Veterans Affairs.

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. According to ClinicalTrials.gov, the official US trial registry.

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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.

Primary Outcome

New or recurrent AIDS event or Death were compared between Standard-ART (standard) and Mega-ART (intensification)

Conditions Studied

HIV Infections AIDS

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

FieldValue
Enrollment Target 368 participants
Start Date 2001-01
Est. Completion 2007-12
Phase NA
US Department of Veterans Affairs

632 total trials

What the finished NCT00050089 record still lists

NCT00050089 is an interventional study that assigns participants to a tested intervention. The registered 368 participants enrollment target is mid-sized for trials with a published cap, below the 445-participant average among 542 other HIV Infections trials with a reported enrollment target (17% lower).

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 names 20 study sites across 12 states, led by 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.

Learn More About Clinical Trials

Similar trials for HIV Infections

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT00050089's enrollment target sits among peer trials

368 93rd of 542 higher than 450 of 542 other HIV Infections trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other HIV Infections trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Related registry views

Source: ClinicalTrials.gov NCT00050089, the US trial registry maintained by the National Library of Medicine. NCT00050089 (mid enrollment · wide site footprint · completed) retrieved and formatted by PlainTrial, see methodology.