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

  Hide Study Locations
Locations
United States, Alabama
Univ of Alabama at Birmingham / AIDS Outpatient Clinic
Birmingham, Alabama, United States, 35294
United States, California
St Mary's Med Ctr
Long Beach, California, United States, 90813
UCSF - San Francisco Gen Hosp
San Francisco, California, United States, 94110
Kaiser Foundation Hospital
San Francisco, California, United States, 94118
United States, District of Columbia
Georgetown Univ Med Ctr
Washington, District of Columbia, United States, 20007
Physicans Home Service
Washington, District of Columbia, United States, 20037
United States, Florida
Associates in Research
Fort Myers, Florida, United States, 33901
Univ of Miami / Jackson Memorial Hosp
Miami, Florida, United States, 33136
United States, Illinois
Illinois Masonic Med Ctr
Chicago, Illinois, United States, 606575147
United States, New Jersey
Saint Michael's Med Ctr / Dept of Infectious Diseases
Newark, New Jersey, United States, 07102
Infectious Disease Specialists of NJ
Union, New Jersey, United States, 07083
United States, New York
Elmhurst Hosp
Elmhurst, New York, United States, 11373
Queens Hospital Center
Jamaica, New York, United States, 11432
LIJMC
New Hyde Park, New York, United States, 11040
United States, North Carolina
East Carolina Univ School of Medicine
Greenville, North Carolina, United States, 27858
United States, Pennsylvania
Lehigh Valley Hosp
Allentown, Pennsylvania, United States, 18105
United States, South Carolina
Burnside Clinic
Columbia, South Carolina, United States, 29206
Greenville Hospital System
Greenville, South Carolina, United States, 29605
United States, Texas
Nicholas Bellos
Dallas, Texas, United States, 75246
Joseph Gathe
Houston, Texas, United States, 77004
United States, Utah
Univ of Utah
Salt Lake City, Utah, United States, 84132
United States, Washington
Univ of Washington / AIDS Clinical Trial Unit
Seattle, Washington, United States, 98104
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, Puerto Rico, 00731
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