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
  Purpose

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


Condition Intervention Phase
HIV Infections
Drug: Ritonavir
Drug: Efavirenz
Drug: Saquinavir
Phase 3

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
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

Resource links provided by NLM:


Further study details as provided by NIH AIDS Clinical Trials Information Service:

Estimated Enrollment: 146
Study Start Date: October 1999
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

ClinicalTrials.gov Identifier: NCT00002447     History of Changes
Other Study ID Numbers: 229R, NR15720C/M61027
Study First Received: November 2, 1999
Last Updated: June 23, 2005
Health Authority: United States: Food and Drug Administration

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:
Acquired Immunodeficiency Syndrome
HIV Infections
Immune System Diseases
Immunologic Deficiency Syndromes
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Sexually Transmitted Diseases
Sexually Transmitted Diseases, Viral
Slow Virus Diseases
Virus Diseases
Efavirenz
Reverse Transcriptase Inhibitors
Ritonavir
Saquinavir
Anti-HIV Agents
Anti-Infective Agents
Anti-Retroviral Agents
Antiviral Agents
Enzyme Inhibitors
HIV Protease Inhibitors
Molecular Mechanisms of Pharmacological Action
Nucleic Acid Synthesis Inhibitors
Pharmacologic Actions
Protease Inhibitors
Therapeutic Uses

ClinicalTrials.gov processed this record on October 23, 2014