Addition of Efavirenz or Nelfinavir to a Lamivudine/Zidovudine/Indinavir HIV Treatment Regimen
Public ClinicalTrials.gov record NCT00000903. 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
A Phase III Randomized, Controlled Trial of Efavirenz (EFV) or Nelfinavir (NFV) in Combination With Fixed-Dose Combination Lamivudine/Zidovudine (3TC/ZDV) and Indinavir (IDV) in HIV-Infected Subjects With Less Than or Equal to 200 CD4 Cells/mm3 or Greater Than or Equal to 80,000 HIV RNA Copies/ml in Plasma
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
To compare time to a virologic failure (first of 2 consecutive plasma HIV RNA levels greater than or equal to 200 copies/ml at or after Week 24) of each 4-drug regimen vs the 3-drug regimen. To determine the safety, tolerance, and virologic benefits of either nelfinavir (NFV) or efavirenz (EFV) with indinavir/lamivudine/zidovudine (IDV/3TC/ZDV) vs IDV/3TC/ZDV alone, in the treatment of patients with advanced HIV disease who have received limited or no prior antiretroviral therapy. Prior ACTG studies have shown that the 3-drug combination regimen (IDV/ZDV/3TC) resulted in improved clinical outcomes and therefore may prolong the effects of therapy. The enhanced effects seen with combination therapies are likely related to a greater suppression of RNA replication and alterations in resistance patterns. Due to the progressive success of combination regimens, it is possible that more potent regimens will further enhance viral suppression and provide more durable treatment responses. In light of the additive suppression of HIV replication determined by pharmacological, immunological, and virological results, nelfinavir (NFV) as an addition to IDV/ZDV/3TC will be evaluated. Based on the potency of nonnucleoside reverse transcriptase inhibitors (NNRTIs) to suppress viral replication and the effectiveness of 3-drug regimens containing NNRTIs, efavirenz (EFV) will also be evaluated as an addition to IDV/ZDV/3TC.
Study identification
- NCT ID
- NCT00000903
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 444 participants
Conditions and interventions
Conditions
Interventions
- Indinavir sulfate Drug
- Lamivudine/Zidovudine Drug
- Nelfinavir mesylate Drug
- Efavirenz Drug
Drug
Eligibility (public fields only)
- Age range
- 13 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 30, 2001
- Last update posted
- May 20, 2012
Ends 2001
United States locations
- U.S. sites
- 49
- U.S. states
- 21
- U.S. cities
- 35
| 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 | — | — |
| Ucsd, Avrc Crs | San Diego | California | 92161 | — |
| Ucsf Aids Crs | San Francisco | California | 941102859 | — |
| Santa Clara Valley Med. Ctr. | San Jose | California | 951282699 | — |
| San Mateo County AIDS Program | San Mateo | California | — | — |
| Marin County Dept. of Health & Human Services, HIV/AIDS Program & Specialty Clinic | San Rafael | California | — | — |
| Harbor-UCLA Med. Ctr. CRS | Torrance | California | 90502 | — |
| University of Colorado Hospital CRS | Aurora | Colorado | 80262 | — |
| Howard University Hosp., Div. of Infectious Diseases, ACTU | Washington D.C. | District of Columbia | 20059 | — |
| Univ. of Miami AIDS CRS | Miami | Florida | 331361013 | — |
| The Ponce de Leon Ctr. CRS | Atlanta | Georgia | 30308 | — |
| Queens Med. Ctr. | Honolulu | Hawaii | 96816 | — |
| Univ. of Hawaii at Manoa, Leahi Hosp. | Honolulu | Hawaii | 96816 | — |
| Northwestern University CRS | Chicago | Illinois | 60611 | — |
| Cook County Hosp. CORE Ctr. | Chicago | Illinois | 60612 | — |
| Rush Univ. Med. Ctr. ACTG CRS | Chicago | Illinois | 60612 | — |
| Weiss Memorial Hosp. | Chicago | Illinois | 60640 | — |
| Indiana Univ. School of Medicine, Wishard Memorial | Indianapolis | Indiana | 462025250 | — |
| Indiana Univ. School of Medicine, Infectious Disease Research Clinic | Indianapolis | Indiana | 46202 | — |
| Methodist Hosp. of Indiana | Indianapolis | Indiana | 46202 | — |
| Univ. of Iowa Healthcare, Div. of Infectious Diseases | Iowa City | Iowa | 52242 | — |
| Tulane Med. Ctr. - Charity Hosp. of New Orleans, ACTU | New Orleans | Louisiana | 70112 | — |
| Johns Hopkins Adult AIDS CRS | Baltimore | Maryland | 21287 | — |
| Beth Israel Deaconess Med. Ctr., ACTG CRS | Boston | Massachusetts | 02215 | — |
| University of Minnesota, ACTU | Minneapolis | Minnesota | 55455 | — |
| St. Louis ConnectCare, Infectious Diseases Clinic | St Louis | Missouri | 63112 | — |
| 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 | — |
| Cornell CRS | New York | New York | 10021 | — |
| Beth Israel Med. Ctr. (Mt. Sinai) | New York | New York | 10029 | — |
| Cornell University A2201 | New York | New York | — | — |
| NY Univ. HIV/AIDS CRS | New York | New York | — | — |
| Weill Med. College of Cornell Univ., The Cornell CTU | New York | New York | — | — |
| Univ. of Rochester ACTG CRS | Rochester | New York | 14642 | — |
| Unc Aids Crs | Chapel Hill | North Carolina | 275997215 | — |
| Carolinas HealthCare System, Carolinas Med. Ctr. | Charlotte | North Carolina | 28203 | — |
| 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 | — |
| Hosp. of the Univ. of Pennsylvania CRS | Philadelphia | Pennsylvania | 19104 | — |
| University of Washington AIDS CRS | Seattle | Washington | 981224304 | — |
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 NCT00000903, 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 20, 2012 · Synced Sep 4, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT00000903 live on ClinicalTrials.gov.