A Comparison of Saquinavir Hard- and Soft-Gelatin Capsules in HIV-Infected Patients
Launched by HOFFMANN-LA ROCHE · Aug 30, 2001
Trial Information
Current as of June 12, 2025
Completed
Keywords
ClinConnect Summary
Patients are randomly assigned to one of the four treatment groups as follows:
Group 1: 10 patients receive saquinavir HGC. Group 2: 10 patients receive saquinavir SGC. Group 3: 30 patients receive saquinavir SGC at an intermediate dose. Group 4: 30 patients receive saquinavir SGC at the highest study dose. Upon completion of the initial 4 weeks, all patients may have the option to continue their originally-assigned therapy as monotherapy unless significant drug toxicity intervenes. If the analysis of the initial 4 week data identifies an optimal dose of saquinavir SGC, patients may have t...
Gender
ALL
Eligibility criteria
- • Inclusion Criteria
- Patients must have:
- • CD4 count of 100 to 500 cells/mm3.
- • Greater than 20,000 HIV-RNA copies/ml.
- • Exclusion Criteria
- Prior Medication:
- Excluded:
- • Prior treatment with protease inhibitors.
- Required:
- • Less than 8 weeks prior antiretroviral treatment (For at least 25% of patients).
- • At least 8 weeks prior antiretroviral treatment (For at least 25% of patients).
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
Boston, Massachusetts, United States
Portland, Oregon, United States
Kansas City, Missouri, United States
New York, New York, United States
Birmingham, Alabama, United States
San Francisco, California, United States
San Francisco, California, United States
Sherman Oaks, California, United States
New Orleans, Louisiana, United States
Galveston, Texas, United States
Patients applied
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
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