A Study of Saquinavir Soft Gelatin Capsules Combined With Other Anti-HIV Drugs in HIV-1 Infected Patients
Information source: NIH AIDS Clinical Trials Information Service
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: HIV Infections
Intervention: Ritonavir (Drug); Nelfinavir mesylate (Drug); Saquinavir (Drug); Stavudine (Drug)
Phase: Phase 3
Status: Completed
Sponsored by: Hoffmann-La Roche
Summary
To examine the efficacy of saquinavir SGC (soft gel capsules) in combination with other
antiretrovirals in HIV-1 infected patients currently treated with saquinavir HGC (hard gel
capsules) measured by the absolute change in plasma HIV-1 RNA during the 24 weeks of study
treatment.
Clinical Details
Official title: A Phase IIIB Open-Label Trial Replacing Saquinavir HGC (Ro 31-8959) With Saquinavir SGC (Ro 31-8959) in Combination With Other Antiretroviral Drugs in Patients With HIV-1 Infection
Study design: Treatment, Safety Study
Detailed description:
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.
Eligibility
Minimum age: 16 Years.
Maximum age: N/A.
Gender(s): Both.
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.
Locations and Contacts
Tower Infectious Diseases / Med Associates Inc, Los Angeles, California 90048, United States
Pacific Oaks Med Ctr, Beverly Hills, California 90211, United States
Community Research Initiative of South Florida, Coral Gables, Florida 33146, United States
Ctr for Quality Care, Tampa, Florida 33609, United States
Community Research Initiative of New England, Brookline, Massachusetts 02445, United States
AIDS Ctr, New York, New York 10011, United States
Anderson Clinical Research / Inc, Pittsburgh, Pennsylvania 15213, United States
Additional Information
Related publications: Cadman J. Roche brings new formulation of saquinavir to FDA. Food and Drug Administration. GMHC Treat Issues. 1997 Apr-May;11(4/5):8. No abstract available.
Last updated: June 23, 2005
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