Comparison of Three Different Initial Treatments Without Protease Inhibitors for HIV Infection
Public ClinicalTrials.gov record NCT00013520. 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
Phase III, Randomized, Double-Blind Comparison of Three Protease Inhibitor-Sparing Regimens for the Initial Treatment of HIV Infection
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT00013520
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 1,125 participants
Conditions and interventions
Conditions
Interventions
- Abacavir sulfate, Lamivudine and Zidovudine Drug
- Atazanavir Drug
- Lamivudine/Zidovudine Drug
- Abacavir sulfate Drug
- Efavirenz Drug
- Nevirapine Drug
- Lamivudine Drug
- Stavudine Drug
- Zidovudine Drug
- Didanosine Drug
Drug
Eligibility (public fields only)
- Age range
- 16 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
- Not listed
- Primary completion
- Not listed
- Completion
- Jun 2005 (Actual)
- Last update posted
- May 21, 2012
Ends 2005
United States locations
- U.S. sites
- 59
- U.S. states
- 22
- U.S. cities
- 37
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Alabama Therapeutics CRS | Birmingham | Alabama | 35294 | — |
| USC CRS | Los Angeles | California | 900331079 | — |
| UCLA CARE Center CRS | Los Angeles | California | 90095 | — |
| Stanford CRS | Palo Alto | California | — | — |
| UC Davis Medical Center | Sacramento | California | 95814 | — |
| Univ. of California Davis Med. Ctr., ACTU | Sacramento | California | — | — |
| Ucsd, Avrc Crs | San Diego | California | 92103 | — |
| Ucsf Aids Crs | San Francisco | California | 94110 | — |
| Santa Clara Valley Med. Ctr. | San Jose | California | — | — |
| San Mateo County AIDS Program | San Mateo | California | 943055107 | — |
| Willow Clinic A0507 CRS | San Mateo | California | — | — |
| Harbor-UCLA Med. Ctr. CRS | Torrance | California | 90502 | — |
| University of Colorado Hospital CRS | Aurora | Colorado | 80262 | — |
| Georgetown University CRS (GU CRS) | Washington D.C. | District of Columbia | 20007 | — |
| Univ. of Miami AIDS CRS | Miami | Florida | 331361013 | — |
| The Ponce de Leon Ctr. CRS | Atlanta | Georgia | 30308 | — |
| Univ. of Hawaii at Manoa, Leahi Hosp. | Honolulu | Hawaii | 96816 | — |
| Northwestern University CRS | Chicago | Illinois | 60611 | — |
| Rush Univ. Med. Ctr. ACTG CRS | Chicago | Illinois | 60612 | — |
| Cook County Hosp. CORE Ctr. | Chicago | Illinois | — | — |
| Indiana Univ. School of Medicine, Infectious Disease Research Clinic | Indianapolis | Indiana | 462025250 | — |
| Indiana Univ. School of Medicine, Wishard Memorial | Indianapolis | Indiana | 46202 | — |
| Methodist Hosp. of Indiana | Indianapolis | Indiana | 46202 | — |
| Univ. of Iowa Healthcare, Div. of Infectious Diseases | Iowa City | Iowa | 52242 | — |
| Johns Hopkins Adult AIDS CRS | Baltimore | Maryland | 21287 | — |
| Massachusetts General Hospital ACTG CRS | Boston | Massachusetts | 02114 | — |
| Bmc Actg Crs | Boston | Massachusetts | 02118 | — |
| Beth Israel Deaconess Med. Ctr., ACTG CRS | Boston | Massachusetts | 02215 | — |
| Brigham and Women's Hosp. ACTG CRS | Boston | Massachusetts | — | — |
| SSTAR, Family Healthcare Ctr. | Fall River | Massachusetts | — | — |
| University of Minnesota, ACTU | Minneapolis | Minnesota | 55455 | — |
| St. Louis ConnectCare, Infectious Diseases Clinic | St Louis | Missouri | — | — |
| Washington U CRS | St Louis | Missouri | — | — |
| Univ. of Nebraska Med. Ctr., Durham Outpatient Ctr. | Omaha | Nebraska | 681985130 | — |
| SUNY - Buffalo, Erie County Medical Ctr. | Buffalo | New York | 14215 | — |
| Beth Israel Med. Ctr., ACTU | New York | New York | 10003 | — |
| Weill Med. College of Cornell Univ., The Cornell CTU | New York | New York | 10011 | — |
| NY Univ. HIV/AIDS CRS | New York | New York | 10016 | — |
| Cornell CRS | New York | New York | 10021 | — |
| Columbia Univ., HIV Prevention and Treatment Medical Ctr. | New York | New York | 10032 | — |
| HIV Prevention & Treatment CRS | New York | New York | — | — |
| Univ. of Rochester ACTG CRS | Rochester | New York | 14642 | — |
| AIDS Care CRS | Rochester | New York | — | — |
| McCree McCuller Wellness Ctr. at the Connection, Infectious Disease Unit | Rochester | New York | — | — |
| Unc Aids Crs | Chapel Hill | North Carolina | 275997215 | — |
| Duke Univ. Med. Ctr. Adult CRS | Durham | North Carolina | 27710 | — |
| Regional Center for Infectious Disease, Wendover Medical Center CRS | Greensboro | North Carolina | 27401 | — |
| Univ. of Cincinnati CRS | Cincinnati | Ohio | 452670405 | — |
| Case CRS | Cleveland | Ohio | 44106 | — |
| MetroHealth CRS | Cleveland | Ohio | 441091998 | — |
| The Ohio State Univ. AIDS CRS | Columbus | Ohio | 432101228 | — |
| Philadelphia Veterans Admin. Med. Ctr. A6205 CRS | Philadelphia | Pennsylvania | 19104 | — |
| Univ. of Pennsylvania Health System, Presbyterian Med. Ctr. | Philadelphia | Pennsylvania | 19104 | — |
| Hosp. of the Univ. of Pennsylvania CRS | Philadelphia | Pennsylvania | — | — |
| Pitt CRS | Pittsburgh | Pennsylvania | 15213 | — |
| The Miriam Hosp. ACTG CRS | Providence | Rhode Island | 02906 | — |
| Rhode Island Hosp. | Providence | Rhode Island | — | — |
| Vanderbilt Therapeutics CRS | Nashville | Tennessee | 37203 | — |
| University of Washington AIDS CRS | Seattle | Washington | 98104 | — |
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 NCT00013520, 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 May 21, 2012 · Synced Oct 26, 2026
Related: full search, browse by condition, browse by drug or therapy, browse by sponsor, browse by U.S. city.
Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT00013520 live on ClinicalTrials.gov.