ABT-378/Ritonavir in Combination With Reverse Transcriptase Inhibitors in Antiretroviral Naïve HIV-Infected Subjects
- Conditions
- HIV Infections
- Interventions
- Registration Number
- NCT00004578
- Lead Sponsor
- Abbott
- Brief Summary
To assess the safety, tolerability and antiviral activity of lopinavir/ritonavir when administered orally in antiretroviral-HIV-1 infected subjects.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 100
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 1 Lopinavir/Ritonavir Group 1, n=32 initiated with ABT-378 \& ritonavir; after 3 wks stavudine and lamivudine was added. 1 Stavudine Group 1, n=32 initiated with ABT-378 \& ritonavir; after 3 wks stavudine and lamivudine was added. 2 Lopinavir/Ritonavir Group II patients (n=68) to be randomized after all Group I patients are enrolled and safety analysis is completed. 1 Lamivudine Group 1, n=32 initiated with ABT-378 \& ritonavir; after 3 wks stavudine and lamivudine was added. 2 Lamivudine Group II patients (n=68) to be randomized after all Group I patients are enrolled and safety analysis is completed. 2 Stavudine Group II patients (n=68) to be randomized after all Group I patients are enrolled and safety analysis is completed.
- Primary Outcome Measures
Name Time Method Proportion of subjects with viral load below the limit of quantitation 24 weeks Time to loss of virologic response 48 weeks
- Secondary Outcome Measures
Name Time Method Proportion of subjects with viral load below the limit of quantitation at each visit At each visit
Trial Locations
- Locations (10)
Northwestern University Medical School
🇺🇸Chicago, Illinois, United States
University of Colorado Health Sciences Center
🇺🇸Denver, Colorado, United States
Baylor College of Medicine
🇺🇸Houston, Texas, United States
Rush-Presbyterian-St. Luke's Medical Center
🇺🇸Chicago, Illinois, United States
Beth Israel Deaconess Medical Center
🇺🇸Boston, Massachusetts, United States
Pacific Oaks Research
🇺🇸Beverly Hills, California, United States
Cornell Clinical Trials Unit - Chelsea Center
🇺🇸New York, New York, United States
University of North Carolina at Chapel Hill
🇺🇸Chapel Hill, North Carolina, United States
Duke University Medical Center
🇺🇸Durham, North Carolina, United States
AIDS Research Consortium of Atlanta
🇺🇸Atlanta, Georgia, United States