A Simplified Kaletra® (Lopinavir/Ritonavir)-Based Therapy Versus a Sustiva® (Efavirenz)-Based Standard of Care in Previously Non-Treated HIV-Infected Subjects
Phase 2
Completed
- Conditions
- HIV Infections
- Registration Number
- NCT00075231
- Lead Sponsor
- Abbott
- Brief Summary
The purpose of this study is to determine whether a simplified lopinavir-ritonavir based therapy will continue to keep the viral load to very low levels after initial treatment with a combination of Kaletra® (lopinavir/ritonavir) plus Combivir® (lamivudine/zidovudine).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 150
Inclusion Criteria
Not provided
Exclusion Criteria
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Proportion of subjects with a plasma HIV RNA level below 50 copies/mL at Week 96.
- Secondary Outcome Measures
Name Time Method
Related Research Topics
Explore scientific publications, clinical data analysis, treatment approaches, and expert-compiled information related to the mechanisms and outcomes of this trial. Click any topic for comprehensive research insights.
What are the molecular mechanisms by which lopinavir/ritonavir maintains viral suppression in HIV-1 subtype B infections?
How does the efficacy of a simplified Kaletra-based regimen compare to efavirenz-based standard of care in antiretroviral-naive patients with CD4+ counts >350 cells/mm³?
Which biomarkers correlate with sustained virologic response to protease inhibitor-based therapies in HIV treatment simplification strategies?
What are the long-term adverse event profiles of lopinavir/ritonavir versus efavirenz in combination antiretroviral therapy for HIV-1 infection?
How do non-nucleoside reverse transcriptase inhibitors like efavirenz compare to protease inhibitor-based regimens in treatment-naive HIV-1 patients with high baseline viral loads?
Trial Locations
- Locations (1)
Fountain Valley Regional Hospital and Medical Center
🇺🇸Fountain Valley, California, United States
Fountain Valley Regional Hospital and Medical Center🇺🇸Fountain Valley, California, United States