Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
CSP #512 - Options in Management With Anti-Retrovirals
NCT00050089 · View on ClinicalTrials.gov ↗
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 |
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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. It is categorized as NA, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 368 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is US Department of Veterans Affairs, which has 158 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT00050089 reports 20 study locations spanning 12 distinct geographic areas — top geographies include California, Florida, Illinois. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
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). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT00050089?
This trial is sponsored by US Department of Veterans Affairs, which has 158 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
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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