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A Study to Compare Two Anti-HIV Drug Combinations

This study has been completed.
Sponsor:
Information provided by:
NIH AIDS Clinical Trials Information Service
ClinicalTrials.gov Identifier:
NCT00002447
First received: November 2, 1999
Last updated: June 23, 2005
Last verified: January 2001

November 2, 1999
June 23, 2005
October 1999
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Complete list of historical versions of study NCT00002447 on ClinicalTrials.gov Archive Site
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A Study to Compare Two Anti-HIV Drug Combinations
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

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

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.

Interventional
Phase 3
Endpoint Classification: Efficacy Study
Primary Purpose: Treatment
HIV Infections
  • Drug: Ritonavir
  • Drug: Efavirenz
  • Drug: Saquinavir
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
146
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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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   Canada,   Puerto Rico
 
NCT00002447
229R, NR15720C/M61027
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Hoffmann-La Roche
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Principal Investigator: JSG Montaner
Study Chair: 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: Joseph Masci
Study Chair: Mahmoud Mustafa
Study Chair: John Schrank
Study Chair: Malte Schutz
Study Chair: Leon Smith
NIH AIDS Clinical Trials Information Service
January 2001

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP