Safety and Efficacy of Kaletra in ARV Therapy Experienced Patients
Information source: Abbott
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: HIV Infections; Kaletra
Intervention: lopinavir/ritonavir (Drug); lopinavir /ritonavir (Drug)
Phase: Phase 4
Status: Terminated
Sponsored by: Abbott
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.
Clinical Details
Official title: Phase IV Non Randomized Study in ARV Experienced Patients Under Switch Therapy With Kaletra
Study design: Treatment, Non-Randomized, Open Label, Parallel Assignment
Primary outcome: Quality of LifeCD4
Secondary outcome: Adverse Event Monitoring
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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
Locations and Contacts
Oaxaca, Mexico
Puebla, Mexico
Tuxtla Gutierrez, Chiapas, Mexico
Mexico City, Distrito Federal, Mexico
Leon, Guanajauto, Mexico
Acapulco, Guerrero, Mexico
Morelia, Michoacan, Mexico
Cuernavaca, Morelia, Mexico
Tepic, Nayarit, Mexico
Monterrey, Nueva Leon, Mexico
Culiacan, Sinaloa, Mexico
Merida, Yucatan, Mexico
Additional Information
Starting date: November 2003
Last updated: March 31, 2008
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