A Study of Saquinavir Soft Gelatin Capsules Combined With Other Anti-HIV Drugs in HIV-1 Infected Patients
Launched by HOFFMANN-LA ROCHE · Aug 30, 2001
Trial Information
Current as of May 19, 2025
Completed
Keywords
ClinConnect Summary
Eligible patients will be stratified by HIV-1 RNA level into 2 populations: 1) \>= 5,000-30,000 HIV-1 RNA, 2) \> 30,000 HIV-1 RNA. All patients will be randomized to 1 of 3 treatment arms: Arm A - Saquinavir soft gel capsules (SQV SGC) + 2 new nucleoside analogs (reverse transcriptase inhibitors \[RTIs\]), Arm B - SQV SGC + nelfinavir + stavudine (d4T) or a new RTI, or Arm C - SQV SGC + ritonavir + d4T or a new RTI. All patients will undergo plasma HIV-1 RNA determinations, CD4 lymphocyte counts, hematology and chemistry blood work at baseline, weeks 4, 8, 12, 16 and 24.
Gender
ALL
Eligibility criteria
- • Inclusion Criteria
- Patients must have:
- • Documented HIV infection.
- • CD4 \> 100 cells/mm3.
- • Saquinavir HGC-experienced patients (\>= 3 months cumulative therapy).
- Required:
- • \>= 3 months cumulative saquinavir HGC therapy.
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
Coral Gables, Florida, United States
Brookline, Massachusetts, United States
Beverly Hills, California, United States
Los Angeles, California, United States
Pittsburgh, Pennsylvania, United States
Tampa, Florida, United States
New York, New York, United States
Patients applied
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
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