Efficacy of Simplified Two Drug Kaletra Regimen vs. Kaletra Triple Drug Standard of Care Regimen in Treatment naïve HIV Infected Patients
Phase 3
Completed
- Conditions
- HIV Infection
- Interventions
- Drug: lopinavir/ritonavir with 2 Nucleoside RTIs
- Registration Number
- NCT00234910
- Lead Sponsor
- Abbott
- Brief Summary
The purpose of this study is to obtain a preliminary assessment of the antiviral activity and tolerability of simplified Kaletra dual agent therapy as initial treatment for HIV infection, relative to a Kaletra three drug standard of care reference arm.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 152
Inclusion Criteria
- HIV positive
- >18 years of age
- HIV RNA> 400 copies/mL
- Any CD 4 cell count
- Antiretroviral naïve
- No acute illness
Exclusion Criteria
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description A Tenofovir DF 2 drug arm B lopinavir/ritonavir with 2 Nucleoside RTIs 3 drug arm, SOC A lopinavir/ritonavir with 2 Nucleoside RTIs 2 drug arm
- Primary Outcome Measures
Name Time Method Antiviral efficacy by HIV RNA 72 wks Incidence of adverse events 72 wks
- Secondary Outcome Measures
Name Time Method Adherence and quality of life 72 wks
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 exerts antiviral activity in HIV-1 treatment naïve patients?
How does the efficacy of dual therapy with Kaletra and tenofovir compare to standard triple antiretroviral regimens in HIV-1 naïve patients?
Which biomarkers correlate with virologic response to lopinavir/ritonavir-based regimens in treatment naïve HIV populations?
What are the key adverse events associated with simplified Kaletra dual therapy versus standard of care triple therapy in HIV management?
How do alternative protease inhibitor combinations compare to Kaletra/TDF in initial HIV treatment strategies according to Abbott's phase III trials?
Trial Locations
- Locations (1)
Global Medical Information-Abbott
🇺🇸Abbott Park, Illinois, United States
Global Medical Information-Abbott🇺🇸Abbott Park, Illinois, United States