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NCT00811954 · ClinicalTrials.gov registry record · Phase 3
Comparative Study of Three NNRTI-Sparing HAART Regimens
A Phase 3 study of HIV Infection, sponsored by Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections.
- Completed
- Registry status
- Phase 3
- Development phase
- 1,814
- Enrollment target
- 20
- Study locations
NCT00811954: Completed Phase 3 study of HIV Infection, sponsored by Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections.
NCT00811954 is a Phase 3 study of HIV Infection that has completed, run by Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections. The registered enrollment target is 1,814 participants, above the 218-participant average among 73 other HIV Infection trials with a reported enrollment target (732% higher). The trial reports 20 study locations across 9 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00811954, a Phase 3 study of HIV Infection, has completed, sponsored by Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 1,814 participants
- Enrollment target
- 20
- Study locations
Study Summary
The U.S. Department of Health and Human Services (HHS) guidelines recommend that HIV infected patients who have never received anti-HIV therapy be treated with a triple drug regimen. The most commonly prescribed and successful regimen contains the medication efavirenz (EFV). However, this regimen may not be an option for everyone, hence alternative regimens are needed. This study was designed to look at how well different combinations of anti-HIV drugs work to decrease the amount of HIV in the blood (viral load) of and allow immune system recovery in people who have never received anti-HIV therapy. This study also examined drug tolerability and safety for the various drug combinations.
Primary Outcome
The Kaplan-Meier estimate of the cumulative probability of virologic failure by week 96. Time to virologic failure was defined as the first time from study entry to the first of two consecutive HIV-1 RNA \>1000 copies/mL at or after week 16 and before week 24, or \>200 copies/mL at or after week 24. Week 16 is defined to occur between 14 (98 days) and 18 weeks (126 days) after study entry, week 24 is defined to occur between 22 (154 days) and 26 (182 days) after study entry, and week 96 is defi
Conditions Studied
Interventions
- DRUG Ritonavir
- DRUG Atazanavir
- DRUG Raltegravir
- DRUG Emtricitabine/tenofovir disoproxil fumarate
- DRUG Darunavir
Study Locations (20)
California
- Miller Children's Hospital - Long Beach
- USC CRS - Los Angeles
- UCLA CARE Center CRS - Los Angeles
- Stanford CRS - Palo Alto
- Ucsd, Avrc Crs - San Diego
- Ucsf Aids Crs - San Francisco
- Harbor-UCLA Med. Ctr. CRS - Torrance
Florida
- South Florida Childrens Diagnostic & Treatment Cen (5055) - Fort Lauderdale
- University of Florida Jacksonville (5051) - Jacksonville
- Univ. of Miami AIDS CRS - Miami
Colorado
- University of Colorado Hospital CRS - Aurora
- Denver Public Health CRS - Denver
District of Columbia
- Georgetown University CRS (GU CRS) - Washington D.C.
- Howard Univ. Washington DC NICHD CRS - Washington D.C.
Illinois
- Northwestern University CRS - Chicago
- Rush Univ. Med. Ctr. ACTG CRS - Chicago
Alabama
- Alabama Therapeutics CRS - Birmingham
Georgia
- The Ponce de Leon Center CRS - Atlanta
Louisiana
- Tulane University New Orleans NICHD CRS (5095) - New Orleans
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,814 participants |
| Start Date | 2009-05 |
| Est. Completion | 2013-06 |
| Phase | Phase 3 |
What the finished NCT00811954 record still lists
NCT00811954 is an interventional study that assigns participants to a tested intervention. Its 1,814 participants enrollment target places it among the larger protocols in the corpus, above the 218-participant average among 73 other HIV Infection trials with a reported enrollment target (732% higher).
The record links to 1 condition, with HIV Infection appearing as the primary indexed condition, and to 5 interventions - of which Ritonavir is the first listed.
NCT00811954 names 20 study sites across 9 states, led by California, Florida, Colorado.
Frequently Asked Questions
What is clinical trial NCT00811954 about?
NCT00811954 is a clinical study titled "Comparative Study of Three NNRTI-Sparing HAART Regimens". The U.S. Department of Health and Human Services (HHS) guidelines recommend that HIV infected patients who have never received anti-HIV therapy be treated with a triple drug regimen. The most commonly prescribed and successful regimen contains the medication efavirenz (EFV). However, this regimen ma...
What is the current status of trial NCT00811954?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 1,814 participants. The study started on 2009-05. Estimated completion is 2013-06.
What conditions does trial NCT00811954 study?
This clinical trial studies the following conditions: HIV Infection.
What interventions are being tested in trial NCT00811954?
The interventions under investigation include: Ritonavir (DRUG), Atazanavir (DRUG), Raltegravir (DRUG), Emtricitabine/tenofovir disoproxil fumarate (DRUG), Darunavir (DRUG).
Who is sponsoring clinical trial NCT00811954?
This trial is sponsored by Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections, which has 45 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00811954 being conducted?
This trial has 20 study locations across Alabama, California, Colorado, District of Columbia, Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Where NCT00811954's enrollment target sits among peer trials
1,814 2nd of 73 the highest of 73 other HIV Infection trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other HIV Infection 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.
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