Back to resultsThe Safety and Effectiveness of Saquinavir Soft Gelatin Capsules Combined With Other Anti-HIV Drugs
Primary Purpose
HIV Infections
Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Saquinavir
Sponsored by
About this trial
This is an interventional treatment trial for HIV Infections focused on measuring Drug Therapy, Combination, Saquinavir, HIV Protease Inhibitors, Dosage Forms, Anti-HIV Agents
Eligibility Criteria
Inclusion Criteria Concurrent Medication: Allowed: Antiretroviral treatments other than PIs. Patients must have: HIV infection. No prior experience with PIs. (Note: At least 75 percent of patients must be naive to PIs.) Exclusion Criteria Concurrent Medication: Excluded: PIs other than SQV. Prior Medication: Excluded: Any PIs (see note in General Criteria--Inclusion).
Sites / Locations
- Consumer Contact
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00002425
Brief Title
The Safety and Effectiveness of Saquinavir Soft Gelatin Capsules Combined With Other Anti-HIV Drugs
Official Title
A Multicenter, Open-Label Study of the Safety and Activity of Saquinavir Soft Gelatin Capsule Formulation (Saquinavir SGC) in Combination With Other Antiretroviral Drugs
Study Type
Interventional
2. Study Status
Record Verification Date
December 1996
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 evaluate the safety and antiretroviral activity of saquinavir soft gelatin capsule formulation (SQV-SGC) in combination with other antiretroviral drugs.
Detailed Description
All patients receive SQV as monotherapy or in combination with other antiretroviral drugs chosen by the investigator and patient. (This study provides only SQV.) Patients may not choose another protease inhibitor (PI) as part of their combination therapy; furthermore, patients taking PIs other than SQV must undergo a 5-day washout period before study-drug administration. Patients are monitored for adverse events and changes in routine laboratory tests, plasma viral load, and CD4+ T cell levels. Outcomes are analyzed by stratifying patients according to CD4+ T cell levels and prior history with protease inhibitors.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV Infections
Keywords
Drug Therapy, Combination, Saquinavir, HIV Protease Inhibitors, Dosage Forms, Anti-HIV Agents
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Enrollment
400 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Saquinavir
10. Eligibility
Sex
All
Minimum Age & Unit of Time
13 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria
Concurrent Medication:
Allowed:
Antiretroviral treatments other than PIs.
Patients must have:
HIV infection.
No prior experience with PIs. (Note:
At least 75 percent of patients must be naive to PIs.)
Exclusion Criteria
Concurrent Medication:
Excluded:
PIs other than SQV.
Prior Medication:
Excluded:
Any PIs (see note in General Criteria--Inclusion).
Facility Information:
Facility Name
Consumer Contact
City
Nutley
State/Province
New Jersey
ZIP/Postal Code
071101199
Country
United States
12. IPD Sharing Statement
Learn more about this trial
The Safety and Effectiveness of Saquinavir Soft Gelatin Capsules Combined With Other Anti-HIV Drugs
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