Clinical Trial: A Study to Compare Two Anti-HIV Drug Combinations

This study has been completed.

Sponsored by: Hoffmann-La Roche
Information provided by: AIDS Clinical Trials Information Service

Purpose

The purpose of this study is to compare 2 anti-HIV drug combinations.

Condition Treatment or Intervention Phase
HIV Infections
 Drug: Ritonavir
 Drug: Efavirenz
 Drug: Saquinavir
Phase III

MedlinePlus related topics:  AIDS

Study Type: Interventional
Study Design: Treatment, Efficacy Study

Official Title: An Open Label, Randomized, Multicenter Study to Evaluate Fortovase (Saquinavir) SGC QD, Norvir (Ritonavir) QD Plus Two NRTIs Vs Sustiva (Efavirenz) QD Plus Two NRTIs in HIV Infected Patients

Further Study Details: 

Expected Total Enrollment:  146

Study start: October 1999

Patients are stratified by HIV RNA: 5,000-75,000 vs greater than 75,000 copies/ml by Amplicor assay. Patients are randomized to two arms. Arm A receives SQV plus RTV plus two NRTIs. Arm B receives EFV plus two NRTIs. Patients must take their dose at approximately the same time every day. Patients have the option of taking daily dose in AM or PM. Patients are evaluated for changes in plasma HIV RNA levels and CD4/CD8 counts and for adverse experiences and laboratory determinations. Evaluations are made every 4-8 weeks until Week 48. Patients continuing beyond Week 48 who reach Weeks 60, 72, 84, and common study closure, will be seen at those weeks.

Eligibility

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Both

Criteria

Inclusion Criteria

Patients may be eligible for this study if they:

  • Are HIV-positive.
  • Have a viral load of at least 5,000 copies/ml and a CD4 cell count of at least 75 cells/mm3.
  • Are at least 18.
  • Are able to complete the study.

Exclusion Criteria

Patients will not be eligible for this study if they:

  • Have taken any anti-HIV medications for more than 2 weeks.
  • Are pregnant or breast-feeding.

Location Information


Alabama
      Univ of Alabama at Birmingham / AIDS Outpatient Clinic, Birmingham,  Alabama,  35294,  United States

California
      UCSF - San Francisco Gen Hosp, San Francisco,  California,  94110,  United States

      Kaiser Foundation Hospital, San Francisco,  California,  94118,  United States

      St Mary's Med Ctr, Long Beach,  California,  90813,  United States

District of Columbia
      Georgetown Univ Med Ctr, Washington,  District of Columbia,  20007,  United States

      Physicans Home Service, Washington,  District of Columbia,  20037,  United States

Florida
      Univ of Miami / Jackson Memorial Hosp, Miami,  Florida,  33136,  United States

      Associates in Research, Fort Myers,  Florida,  33901,  United States

Illinois
      Illinois Masonic Med Ctr, Chicago,  Illinois,  606575147,  United States

New Jersey
      Saint Michael's Med Ctr / Dept of Infectious Diseases, Newark,  New Jersey,  07102,  United States

      Infectious Disease Specialists of NJ, Union,  New Jersey,  07083,  United States

New York
      Elmhurst Hosp, Elmhurst,  New York,  11373,  United States

      Queens Hospital Center, Jamaica,  New York,  11432,  United States

      LIJMC, New Hyde Park,  New York,  11040,  United States

North Carolina
      East Carolina Univ School of Medicine, Greenville,  North Carolina,  27858,  United States

Pennsylvania
      Lehigh Valley Hosp, Allentown,  Pennsylvania,  18105,  United States

South Carolina
      Burnside Clinic, Columbia,  South Carolina,  29206,  United States

      Greenville Hospital System, Greenville,  South Carolina,  29605,  United States

Texas
      Joseph Gathe, Houston,  Texas,  77004,  United States

      Nicholas Bellos, Dallas,  Texas,  75246,  United States

Utah
      Univ of Utah, Salt Lake City,  Utah,  84132,  United States

Washington
      Univ of Washington / AIDS Clinical Trial Unit, Seattle,  Washington,  98104,  United States

Canada, British Columbia
      Saint Paul's Hosp, Vancouver,  British Columbia,  Canada

Canada, Ontario
      Toronto Gen Hosp, Toronto,  Ontario,  Canada

Canada, Quebec
      Centre Hospitalier de la Universite de Montreal (CHUM), Montreal,  Quebec,  Canada

Puerto Rico
      Ponce Univ Hosp, Ponce,  00731,  Puerto Rico

Study chairs or principal investigators

JSG Montaner,  Principal Investigator
Ann Collier,  Study Chair
Danielle Rouleau,  Study Chair
Michael Saag,  Study Chair
Paul Volberding,  Study Chair
Sharon Walmsley,  Study Chair
Nicholas Bellos,  Study Chair
Alfred Burnside,  Study Chair
Stephen Follansbee,  Study Chair
Joseph Gathe,  Study Chair
Bruce Hathaway,  Study Chair
Margaret Hoffman-Terry,  Study Chair
Jazila Mantis,  Study Chair
Jazila Mantis,  Study Chair
Joseph Masci,  Study Chair
Mahmoud Mustafa,  Study Chair
John Schrank,  Study Chair
Malte Schutz,  Study Chair
Leon Smith,  Study Chair

More Information

Study ID Numbers:  229R; NR15720C/M61027
Record last reviewed:  January 2001
Last Updated:  October 13, 2004
Record first received:  November 2, 1999
ClinicalTrials.gov Identifier:  NCT00002447
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-04-08


Source: ClinicalTrials.gov
Cache Date: April 9, 2005

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