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Clinical trialNCT00000903CompletedPhase 3Interventional

Addition of Efavirenz or Nelfinavir to a Lamivudine/Zidovudine/Indinavir HIV Treatment Regimen

SponsorNational Institute of Allergy and Infectious Diseases (NIAID)Enrollment444HIV Infections
View the registry record on ClinicalTrials.gov

Summary

The lay summary the sponsor registered on ClinicalTrials.gov.

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.

Investigators

The overall officials registered on this study. Names that resolve to a findmyKOL profile link to it; the rest are shown as registered.

A profile link is shown only when the registered name resolves to a person record with a confident, namesake-checked match; ambiguous names stay unlinked.

Sites

50 registered facilities, with the per-site recruitment status where the registry publishes one. ClinicalTrials.gov does not publish per-site enrollment counts.

Puerto Rico
  • Puerto Rico-Aids Crs

    San Juan, Puerto Rico

United States
  • Alabama Therapeutics Crs

    Birmingham, Alabama, United States

  • Ucla Care Center Crs

    Los Angeles, California, United States

  • Usc Crs

    Los Angeles, California, United States

  • Stanford Crs

    Palo Alto, California, United States

  • Ucsd, Avrc Crs

    San Diego, California, United States

  • Ucsf Aids Crs

    San Francisco, California, United States

  • Santa Clara Valley Med. Ctr.

    San Jose, California, United States

  • San Mateo County Aids Program

    San Mateo, California, United States

  • Marin County Dept. of Health & Human Services, Hiv/aids Program & Specialty Clinic

    San Rafael, California, United States

  • Harbor-Ucla Med. Ctr. Crs

    Torrance, California, United States

  • University of Colorado Hospital Crs

    Aurora, Colorado, United States

  • Howard University Hosp., Div. of Infectious Diseases, Actu

    Washington D.C., District of Columbia, United States

  • Univ. of Miami Aids Crs

    Miami, Florida, United States

  • the Ponce de Leon Ctr. Crs

    Atlanta, Georgia, United States

  • Queens Med. Ctr.

    Honolulu, Hawaii, United States

  • Univ. of Hawaii at Manoa, Leahi Hosp.

    Honolulu, Hawaii, United States

  • Cook County Hosp. Core Ctr.

    Chicago, Illinois, United States

  • Northwestern University Crs

    Chicago, Illinois, United States

  • Rush Univ. Med. Ctr. Actg Crs

    Chicago, Illinois, United States

  • Weiss Memorial Hosp.

    Chicago, Illinois, United States

  • Indiana Univ. School of Medicine, Infectious Disease Research Clinic

    Indianapolis, Indiana, United States

  • Indiana Univ. School of Medicine, Wishard Memorial

    Indianapolis, Indiana, United States

  • Methodist Hosp. of Indiana

    Indianapolis, Indiana, United States

  • Univ. of Iowa Healthcare, Div. of Infectious Diseases

    Iowa City, Iowa, United States

  • Tulane Med. Ctr. - Charity Hosp. of New Orleans, Actu

    New Orleans, Louisiana, United States

  • Johns Hopkins Adult Aids Crs

    Baltimore, Maryland, United States

  • Beth Israel Deaconess Med. Ctr., Actg Crs

    Boston, Massachusetts, United States

  • University of Minnesota, Actu

    Minneapolis, Minnesota, United States

  • St. Louis Connectcare, Infectious Diseases Clinic

    St Louis, Missouri, United States

  • Washington U Crs

    St Louis, Missouri, United States

  • Univ. of Nebraska Med. Ctr., Durham Outpatient Ctr.

    Omaha, Nebraska, United States

  • Suny - Buffalo, Erie County Medical Ctr.

    Buffalo, New York, United States

  • Beth Israel Med. Ctr. (mt. Sinai)

    New York, New York, United States

  • Beth Israel Med. Ctr., Actu

    New York, New York, United States

  • Cornell Crs

    New York, New York, United States

  • Cornell University A2201

    New York, New York, United States

  • Ny Univ. Hiv/aids Crs

    New York, New York, United States

  • Weill Med. College of Cornell Univ., the Cornell Ctu

    New York, New York, United States

  • Univ. of Rochester Actg Crs

    Rochester, New York, United States

10 more sites on the registry record.ClinicalTrials.gov ↗

Site investigator names are published by ClinicalTrials.gov only while a study recruits, so completed studies list sites without them.

Drugs studied

The drug and biological interventions registered on this study, normalized to their RxNorm ingredient where possible.

Linked drugs open the directory filtered to KOLs working with them.clinicaltrials.gov ↗

Registration & key dates

Registry attributes as recorded on the ClinicalTrials.gov study record.

Start
—
Primary completion
—
Completion
31 Jul 2001
Last update posted
21 May 2012
Registered enrollment
444
Registry id
NCT00000903

Source: ClinicalTrials.gov, via the CTTI AACT database, data as of 24 Aug 2026. Registry facts are shown as registered by the study sponsor; findmyKOL does not interpret them.