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A Study to Compare Two Anti-HIV Drug Combinations

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00002447
Recruitment Status : Completed
First Posted : August 31, 2001
Last Update Posted : June 24, 2005
Sponsor:
Information provided by:

Study Description
Brief Summary:
The purpose of this study is to compare 2 anti-HIV drug combinations.

Condition or disease Intervention/treatment Phase
HIV Infections Drug: Ritonavir Drug: Efavirenz Drug: Saquinavir Phase 3

Detailed Description:
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.

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 146 participants
Primary Purpose: Treatment
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
Study Start Date : October 1999

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS
U.S. FDA Resources

Arms and Interventions


Outcome Measures

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00002447


  Show 26 Study Locations
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
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
More Information

ClinicalTrials.gov Identifier: NCT00002447     History of Changes
Other Study ID Numbers: 229R
NR15720C/M61027
First Posted: August 31, 2001    Key Record Dates
Last Update Posted: June 24, 2005
Last Verified: January 2001

Keywords provided by NIH AIDS Clinical Trials Information Service:
Drug Therapy, Combination
Saquinavir
HIV Protease Inhibitors
Ritonavir
Dosage Forms
Reverse Transcriptase Inhibitors
Anti-HIV Agents
efavirenz

Additional relevant MeSH terms:
HIV Infections
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Ritonavir
Saquinavir
Efavirenz
HIV Protease Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-HIV Agents
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
Cytochrome P-450 CYP3A Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Reverse Transcriptase Inhibitors
Nucleic Acid Synthesis Inhibitors
Cytochrome P-450 CYP2C9 Inhibitors
Cytochrome P-450 CYP2C19 Inhibitors
Cytochrome P-450 CYP2B6 Inducers
Cytochrome P-450 Enzyme Inducers
Cytochrome P-450 CYP3A Inducers