Back to resultsA Phase IIIB Open-Label, Comparative Study to Evaluate Saquinavir Soft Gel Capsule (SGC) Treatment in Combination With Other Antiretrovirals in HIV-1 Infected Antiretroviral-Naive Patients
Primary Purpose
HIV Infections
Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Ritonavir
Nelfinavir mesylate
Saquinavir
Delavirdine mesylate
Sponsored by
About this trial
This is an interventional treatment trial for HIV Infections focused on measuring HIV-1, Drug Therapy, Combination, HIV Protease Inhibitors, RNA, Viral, Dosage Forms, Saquinavir, Reverse Transcriptase Inhibitors, Anti-HIV Agents, Viral Load
Eligibility Criteria
Inclusion Criteria Patients must have: HIV RNA >= 5000 copies/ml by Amplicor assay. Signed, informed consent from parent or legal guardian for patients less than 18 years old. Previous treatment with antiretrovirals.
Sites / Locations
- Dr Charles Farthing
- Community Research Initiative
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00002178
Brief Title
A Phase IIIB Open-Label, Comparative Study to Evaluate Saquinavir Soft Gel Capsule (SGC) Treatment in Combination With Other Antiretrovirals in HIV-1 Infected Antiretroviral-Naive Patients
Official Title
A Phase IIIB Open-Label, Comparative Study to Evaluate Saquinavir Soft Gel Capsule (SGC) Treatment in Combination With Other Antiretrovirals in HIV-1 Infected Antiretroviral-Naive Patients
Study Type
Interventional
2. Study Status
Record Verification Date
August 1997
Overall Recruitment Status
Completed
Study Start Date
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Primary Completion Date
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Study Completion Date
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3. Sponsor/Collaborators
Name of the Sponsor
Hoffmann-La Roche
4. Oversight
5. Study Description
Brief Summary
To determine the proportion of patients whose plasma HIV-1 RNA level falls below the level of detection (< 400 copies/ml) at week 16 and 24 of study therapy. To determine the absolute change in plasma HIV-1 RNA and in absolute CD4 cell count during the 24 weeks of study treatment. To collect safety data on the treatment regimens. To determine the percentage of patients without SQV soft gel capsules resistance-associated mutations at week 24.
Detailed Description
Patients are randomized to receive 1 of 3 study regimens: Group A - Saquinavir (SQV) soft gel capsules (sgc) plus 2 reverse transcriptase inhibitors (RTIs), Group B - SQV sgc plus delavirdine plus RTI, and Group C - SQV sgc plus nelfinavir plus RTI (or SQV sgc plus ritonavir plus 2 RTIs).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV Infections
Keywords
HIV-1, Drug Therapy, Combination, HIV Protease Inhibitors, RNA, Viral, Dosage Forms, Saquinavir, Reverse Transcriptase Inhibitors, Anti-HIV Agents, Viral Load
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Enrollment
375 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Ritonavir
Intervention Type
Drug
Intervention Name(s)
Nelfinavir mesylate
Intervention Type
Drug
Intervention Name(s)
Saquinavir
Intervention Type
Drug
Intervention Name(s)
Delavirdine mesylate
10. Eligibility
Sex
All
Minimum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria
Patients must have:
HIV RNA >= 5000 copies/ml by Amplicor assay.
Signed, informed consent from parent or legal guardian for patients less than 18 years old.
Previous treatment with antiretrovirals.
Facility Information:
Facility Name
Dr Charles Farthing
City
Los Angeles
State/Province
California
ZIP/Postal Code
90048
Country
United States
Facility Name
Community Research Initiative
City
Brookline
State/Province
Massachusetts
ZIP/Postal Code
02445
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
11364377
Citation
Cadman J. Roche brings new formulation of saquinavir to FDA. Food and Drug Administration. GMHC Treat Issues. 1997 Apr-May;11(4/5):8.
Results Reference
background
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A Phase IIIB Open-Label, Comparative Study to Evaluate Saquinavir Soft Gel Capsule (SGC) Treatment in Combination With Other Antiretrovirals in HIV-1 Infected Antiretroviral-Naive Patients
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