Safety and Efficacy of Kaletra in ARV Therapy Experienced Patients
- Registration Number
- NCT00648999
- Lead Sponsor
- AbbVie (prior sponsor, Abbott)
- Brief Summary
To demonstrate that patients treated with Kaletra have an improvement in their quality of life compared to the quality of life they had with their previous NRTI therapy.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 207
- HIV Infected subjects
- Subjects failing in current HIV treatment, or
- Subjects with a viral load < 400 copies/mL and not tolerating their current HIV treatment.
- Subject is currently participating in another clinical study or has participated in another clinical study within 30 days prior to screening visit
- Subject is pregnant
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 2 lopinavir/ritonavir - 1 lopinavir/ritonavir -
- Primary Outcome Measures
Name Time Method Quality of Life Baseline, Week 4, Week 24 and Week 48 CD4 Baseline, Week 24 and Week 48
- Secondary Outcome Measures
Name Time Method Adverse Event Monitoring Baseline, Week 4, Week 24 and Week 48
Trial Locations
- Locations (13)
Site Ref # / Investigator 4049
🇲🇽Mexico City, Distrito Federal, Mexico
Site Ref # / Investigator 4050
🇲🇽Mexico City, Distrito Federal, Mexico
Site Ref # / Investigator 4051
🇲🇽Mexico City, Distrito Federal, Mexico
Site Ref # / Investigator 4077
🇲🇽Mexico City, Distrito Federal, Mexico
Site Ref # / Investigator 4056
🇲🇽Mexico City, Distrito Federal, Mexico
Site Ref # / Investigator 4074
🇲🇽Leon, Guanajauto, Mexico
Site Ref # / Investigator 4054
🇲🇽Morelia, Michoacan, Mexico
Site Ref # / Investigator 4072
🇲🇽Tepic, Nayarit, Mexico
Site Ref # / Investigator 4055
🇲🇽Culiacan, Sinaloa, Mexico
Site Ref # / Investigator 4075
🇲🇽Merida, Yucatan, Mexico
Scroll for more (3 remaining)Site Ref # / Investigator 4049🇲🇽Mexico City, Distrito Federal, Mexico