Search / Trial NCT00002447

A Study to Compare Two Anti-HIV Drug Combinations

Launched by HOFFMANN-LA ROCHE · Aug 30, 2001

Trial Information

Current as of November 04, 2024

Completed

Keywords

Drug Therapy, Combination Saquinavir Hiv Protease Inhibitors Ritonavir Dosage Forms Reverse Transcriptase Inhibitors Anti Hiv Agents Efavirenz

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.

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.

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

Similar Trials