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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 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.
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.
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 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00811954
The ClinicalTrials.gov registry entry for NCT00811954 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 1,814 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 218-participant average among 73 other HIV Infection trials with a reported enrollment target (732% higher). The listed sponsor is Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections, which has 45 total studies on file at ClinicalTrials.gov.
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 reports 20 study locations spanning 9 distinct geographic areas - top geographies include 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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