Back to resultsA Phase II Open-Label Exploratory Study of Saquinavir + Zidovudine + Lamivudine in HIV Infected Patients
Primary Purpose
HIV Infections
Status
Completed
Phase
Phase 2
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, Zidovudine, HIV Protease Inhibitors, Lamivudine, Saquinavir, Reverse Transcriptase Inhibitors, Anti-HIV Agents
Eligibility Criteria
Inclusion Criteria Patients must have: HIV antibody positive. CD4 count >= 150 and <= 500 cells/mm3. Exclusion Criteria Prior Medication: Excluded: Prior antiretroviral therapy. Prior protease inhibitor therapy.
Sites / Locations
- Davies Med Ctr / c/o HIV Institute
- Pacific Oaks Med Group / Rsch & Scientific Investigation
- Columbia Presbyterian Med Ctr
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00002190
Brief Title
A Phase II Open-Label Exploratory Study of Saquinavir + Zidovudine + Lamivudine in HIV Infected Patients
Official Title
A Phase II Open-Label Exploratory Study of Saquinavir + Zidovudine + Lamivudine in HIV Infected Patients
Study Type
Interventional
2. Study Status
Record Verification Date
July 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 explore the antiviral efficacy, tolerability and safety of saquinavir plus zidovudine plus lamivudine.
Detailed Description
A total of 30 patients receive the triple drug regimen saquinavir plus zidovudine plus lamivudine until the completion of the analysis after at least 4 weeks of therapy.
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, Zidovudine, HIV Protease Inhibitors, Lamivudine, Saquinavir, Reverse Transcriptase Inhibitors, Anti-HIV Agents
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Enrollment
30 (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
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria
Patients must have:
HIV antibody positive.
CD4 count >= 150 and <= 500 cells/mm3.
Exclusion Criteria
Prior Medication:
Excluded:
Prior antiretroviral therapy.
Prior protease inhibitor therapy.
Facility Information:
Facility Name
Davies Med Ctr / c/o HIV Institute
City
San Francisco
State/Province
California
ZIP/Postal Code
94114
Country
United States
Facility Name
Pacific Oaks Med Group / Rsch & Scientific Investigation
City
Sherman Oaks
State/Province
California
ZIP/Postal Code
91403
Country
United States
Facility Name
Columbia Presbyterian Med Ctr
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
12. IPD Sharing Statement
Learn more about this trial
A Phase II Open-Label Exploratory Study of Saquinavir + Zidovudine + Lamivudine in HIV Infected Patients
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