CSP #512 - Options in Management With Anti-Retrovirals
Public ClinicalTrials.gov record NCT00050089. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
CSP #512 - Options in Management With Anti-Retrovirals (OPTIMA), Management of Patients With HIV Infection for Whom First and Second-line Highly Active Anti-Retroviral Therapy Has Failed
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT00050089
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Not applicable
- Enrollment
- 368 participants
Conditions and interventions
Conditions
Interventions
Other · Drug
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Jan 2001 (Type not available)
- Primary completion
- Dec 2007 (Actual)
- Completion
- Dec 2007 (Actual)
- Last update posted
- Apr 23, 2015
2001 – 2007
United States locations
- U.S. sites
- 29
- U.S. states
- 18
- U.S. cities
- 29
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Carl T. Hayden VA Medical Center | Phoenix | Arizona | 85012 | — |
| VA Medical Center, Long Beach | Long Beach | California | 90822 | — |
| VA Palo Alto Health Care System | Palo Alto | California | 94304-1290 | — |
| VA San Diego Healthcare System, San Diego | San Diego | California | 92161 | — |
| VA Greater Los Angeles Healthcare System, West LA | West Los Angeles | California | 90073 | — |
| VA Connecticut Health Care System (West Haven) | West Haven | Connecticut | 06516 | — |
| VA Medical Center, DC | Washington D.C. | District of Columbia | 20422 | — |
| North Florida/South Georgia Veterans Health System | Gainesville | Florida | 32608 | — |
| VA Medical Center, Miami | Miami | Florida | 33125 | — |
| Bay Pines VAMC (111J) | St. Petersburg | Florida | 33708 | — |
| West Palm Beach VA Medical Center | West Palm Beach | Florida | 33410 | — |
| Atlanta VA Medical and Rehab Center, Decatur | Decatur | Georgia | 30033 | — |
| Jesse Brown VAMC (WestSide Division) | Chicago | Illinois | 60612 | — |
| Edward Hines, Jr. VA Hospital | Hines | Illinois | 60141-5000 | — |
| VA Maryland Health Care System, Baltimore | Baltimore | Maryland | 21201 | — |
| VA Medical Center, Jamaica Plain Campus | Boston | Massachusetts | 02130 | — |
| VA Ann Arbor Healthcare System | Ann Arbor | Michigan | 48113 | — |
| VA New Jersey Health Care System, East Orange | East Orange | New Jersey | 07018 | — |
| New York Harbor HCS | New York | New York | 10010 | — |
| VA Medical Center, Bronx | The Bronx | New York | 10468 | — |
| VA Medical Center, Durham | Durham | North Carolina | 27705 | — |
| VA Medical Center, Cincinnati | Cincinnati | Ohio | 45220 | — |
| VA Medical Center, Cleveland | Cleveland | Ohio | 44106 | — |
| VA Medical Center, Portland | Portland | Oregon | 97201 | — |
| VA Medical Center, Philadelphia | Philadelphia | Pennsylvania | 19104 | — |
| WJB Dorn Veterans Hospital, Columbia | Columbia | South Carolina | 29209 | — |
| VA North Texas Health Care System, Dallas | Dallas | Texas | 75216 | — |
| Michael E. DeBakey VA Medical Center (152) | Houston | Texas | 77030 | — |
| VA South Texas Health Care System, San Antonio | San Antonio | Texas | 78229 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 1 non-U.S. site.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT00050089, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Apr 23, 2015 · Synced Oct 20, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT00050089 live on ClinicalTrials.gov.