A Study to Compare Two Anti-HIV Drug Combinations
Launched by HOFFMANN-LA ROCHE · Aug 30, 2001
Trial Information
Current as of March 19, 2025
Completed
Keywords
ClinConnect Summary
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, ...
Gender
ALL
Eligibility 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.
Trial Officials
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
Joseph Masci
Study Chair
Mahmoud Mustafa
Study Chair
John Schrank
Study Chair
Malte Schutz
Study Chair
Leon Smith
Study Chair
About Hoffmann La Roche
Hoffmann-La Roche, commonly known as Roche, is a global leader in biotechnology and pharmaceuticals, committed to advancing healthcare through innovative research and development. With a strong focus on oncology, immunology, infectious diseases, and central nervous system disorders, Roche leverages cutting-edge science to deliver transformative therapies and diagnostics. The company is dedicated to improving patient outcomes by conducting rigorous clinical trials and collaborating with healthcare professionals and organizations worldwide. Roche's unwavering commitment to precision medicine and personalized healthcare positions it at the forefront of the industry, driving progress in the quest for effective treatments and improved patient care.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Washington, District Of Columbia, United States
San Francisco, California, United States
Miami, Florida, United States
Chicago, Illinois, United States
Vancouver, British Columbia, Canada
Toronto, Ontario, Canada
Ponce, , Puerto Rico
Birmingham, Alabama, United States
Seattle, Washington, United States
San Francisco, California, United States
Columbia, South Carolina, United States
Greenville, North Carolina, United States
Elmhurst, New York, United States
Allentown, Pennsylvania, United States
Newark, New Jersey, United States
Fort Myers, Florida, United States
Houston, Texas, United States
Washington, District Of Columbia, United States
Union, New Jersey, United States
Long Beach, California, United States
Jamaica, New York, United States
New Hyde Park, New York, United States
Greenville, South Carolina, United States
Dallas, Texas, United States
Salt Lake City, Utah, United States
Montreal, Quebec, Canada
People applied
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
Discussion 0
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