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NCT00013520 · ClinicalTrials.gov registry record · Phase 3
Comparison of Three Different Initial Treatments Without Protease Inhibitors for HIV Infection
A Phase 3 study of HIV Infections, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- Completed
- Registry status
- Phase 3
- Development phase
- 1,125
- Enrollment target
- 20
- Study locations
NCT00013520: Completed Phase 3 study of HIV Infections, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
NCT00013520 is a Phase 3 study of HIV Infections that has completed, run by National Institute of Allergy and Infectious Diseases (NIAID). The registered enrollment target is 1,125 participants, above the 444-participant average among 542 other HIV Infections trials with a reported enrollment target (153% higher). The trial reports 20 study locations across 8 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00013520, a Phase 3 study of HIV Infections, has completed, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 1,125 participants
- Enrollment target
- 20
- Study locations
Study Summary
The purpose of this study is to compare the effectiveness, safety, and tolerability of 3 anti-HIV combination treatments that do not use protease inhibitors (PIs). The current rule for starting treatment of HIV infection is to combine members from different classes of anti-HIV drugs, such as 2 nucleoside reverse transcriptase inhibitors (NRTIs) and either a PI or a nonnucleoside reverse transcriptase inhibitor (NNRTI). However, these combinations can be complicated and difficult to take, can cause a number of side effects, and may become ineffective. Combinations that are simpler, better tolerated, and more effective are needed. Because PIs can cause long-term side effects and because HIV can become resistant to many of them at the same time, anti-HIV combination treatments that do not use PIs are being tested.
Conditions Studied
Interventions
- DRUG Atazanavir
- DRUG Efavirenz
- DRUG Lamivudine/Zidovudine
- DRUG Abacavir sulfate
- DRUG Abacavir sulfate, Lamivudine and Zidovudine
Study Locations (20)
California
- USC CRS - Los Angeles
- UCLA CARE Center CRS - Los Angeles
- Stanford CRS - Palo Alto
- UC Davis Medical Center - Sacramento
- Univ. of California Davis Med. Ctr., ACTU - Sacramento
- Ucsd, Avrc Crs - San Diego
- Ucsf Aids Crs - San Francisco
- Santa Clara Valley Med. Ctr. - San Jose
- San Mateo County AIDS Program - San Mateo
- Willow Clinic A0507 CRS - San Mateo
- Harbor-UCLA Med. Ctr. CRS - Torrance
Illinois
- Northwestern University CRS - Chicago
- Rush Univ. Med. Ctr. ACTG CRS - Chicago
- Cook County Hosp. CORE Ctr. - Chicago
Alabama
- Alabama Therapeutics CRS - Birmingham
Colorado
- University of Colorado Hospital CRS - Aurora
District of Columbia
- Georgetown University CRS (GU CRS) - Washington D.C.
Florida
- Univ. of Miami AIDS CRS - Miami
Georgia
- The Ponce de Leon Ctr. CRS - Atlanta
Hawaii
- Univ. of Hawaii at Manoa, Leahi Hosp. - Honolulu
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,125 participants |
| Est. Completion | 2005-06 |
| Phase | Phase 3 |
What the finished NCT00013520 record still lists
NCT00013520 is an interventional study that assigns participants to a tested intervention. Its 1,125 participants enrollment target places it among the larger protocols in the corpus, above the 444-participant average among 542 other HIV Infections trials with a reported enrollment target (153% higher).
The record links to 1 condition, with HIV Infections appearing as the primary indexed condition, and to 5 interventions - of which Atazanavir is the first listed.
NCT00013520 names 20 study sites across 8 states, led by California, Illinois, Alabama.
Frequently Asked Questions
What is clinical trial NCT00013520 about?
NCT00013520 is a clinical study titled "Comparison of Three Different Initial Treatments Without Protease Inhibitors for HIV Infection". The purpose of this study is to compare the effectiveness, safety, and tolerability of 3 anti-HIV combination treatments that do not use protease inhibitors (PIs). The current rule for starting treatment of HIV infection is to combine members from different classes of anti-HIV drugs, such as 2 nucl...
What is the current status of trial NCT00013520?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 1,125 participants. Estimated completion is 2005-06.
What conditions does trial NCT00013520 study?
This clinical trial studies the following conditions: HIV Infections.
What interventions are being tested in trial NCT00013520?
The interventions under investigation include: Atazanavir (DRUG), Efavirenz (DRUG), Lamivudine/Zidovudine (DRUG), Abacavir sulfate (DRUG), Abacavir sulfate, Lamivudine and Zidovudine (DRUG).
Who is sponsoring clinical trial NCT00013520?
This trial is sponsored by National Institute of Allergy and Infectious Diseases (NIAID), which has 2,006 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00013520 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.
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 NCT00013520's enrollment target sits among peer trials
1,125 25th of 542 higher than 518 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.
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