Back to resultsA Study of Saquinavir Soft Gelatin Capsules Plus Zidovudine Plus Lamivudine in the Treatment of HIV-1 Infected Patients Who Have Never Taken Anti-HIV Drugs
Primary Purpose
HIV Infections
Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Saquinavir
Lamivudine
Zidovudine
Sponsored by
About this trial
This is an interventional treatment trial for HIV Infections focused on measuring Drug Therapy, Combination, Acquired Immunodeficiency Syndrome, Zidovudine, HIV Protease Inhibitors, Lamivudine, Saquinavir, Reverse Transcriptase Inhibitors, Anti-HIV Agents
Eligibility Criteria
Inclusion Criteria Patients must have: Plasma HIV-1 RNA titers > 10,000 copies/ml. CD4 cell count > 100 cells/mm3. Exclusion Criteria Co-existing Condition: Patients with any of the following conditions will be excluded: Any prior anti-retroviral drug therapy. Prior Medication: Excluded: Previous anti-retroviral drug therapy.
Sites / Locations
- AIDS Healthcare Foundation Labs
- Urgent Care Ctr / North Broward Hosp District
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00002367
Brief Title
A Study of Saquinavir Soft Gelatin Capsules Plus Zidovudine Plus Lamivudine in the Treatment of HIV-1 Infected Patients Who Have Never Taken Anti-HIV Drugs
Official Title
An Open-Label, Non-Comparative Study of Saquinavir-SGC in Combination With Zidovudine (AZT) and Lamivudine (3TC) in the Treatment of HIV-1 Infected Patients With No Previous Anti-Retroviral Drug Therapy
Study Type
Interventional
2. Study Status
Record Verification Date
August 1997
Overall Recruitment Status
Completed
Study Start Date
undefined (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Hoffmann-La Roche
4. Oversight
5. Study Description
Brief Summary
To evaluate the efficacy of Saquinavir-SGC combination with Zidovudine and Lamivudine in the treatment of HIV-1 infected patients with no previous anti-retroviral drug therapy.
Detailed Description
All enrolled patients will receive the following 3 drug combination: Saquinavir, Zidovudine and Lamivudine. Efficacy and duration of anti-viral response will be evaluated by monitoring of HIV-1 RNA levels. Patients below the detectable limit of 200 copies/ml will be analyzed using the Ultra-direct method with a detection limit of 20 copies/ml. CD4 and CD8 cell counts will also be analyzed.
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, Acquired Immunodeficiency Syndrome, Zidovudine, HIV Protease Inhibitors, Lamivudine, Saquinavir, Reverse Transcriptase Inhibitors, Anti-HIV Agents
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Enrollment
40 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Saquinavir
Intervention Type
Drug
Intervention Name(s)
Lamivudine
Intervention Type
Drug
Intervention Name(s)
Zidovudine
10. Eligibility
Sex
All
Minimum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria
Patients must have:
Plasma HIV-1 RNA titers > 10,000 copies/ml.
CD4 cell count > 100 cells/mm3.
Exclusion Criteria
Co-existing Condition:
Patients with any of the following conditions will be excluded:
Any prior anti-retroviral drug therapy.
Prior Medication:
Excluded:
Previous anti-retroviral drug therapy.
Facility Information:
Facility Name
AIDS Healthcare Foundation Labs
City
Los Angeles
State/Province
California
ZIP/Postal Code
90048
Country
United States
Facility Name
Urgent Care Ctr / North Broward Hosp District
City
Fort Lauderdale
State/Province
Florida
ZIP/Postal Code
33316
Country
United States
12. IPD Sharing Statement
Learn more about this trial
A Study of Saquinavir Soft Gelatin Capsules Plus Zidovudine Plus Lamivudine in the Treatment of HIV-1 Infected Patients Who Have Never Taken Anti-HIV Drugs
We'll reach out to this number within 24 hrs