Clinical Trials Directory

Trials / Completed

CompletedNCT01083810

Evaluation of Kaletra Therapy Over the Long-term

Status
Completed
Phase
Study type
Observational
Enrollment
284 (actual)
Sponsor
Abbott · Industry
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

Summary

Long term observation of patients under lopinavir/ritonavir containing therapy

Detailed description

Three to five year observation of lopinavir/ritonavir therapy. Reporting groups are 1) therapy-naïve patients (144 weeks), 2) therapy-experienced but protease inhibitor naïve patients (240 weeks,) and 3) non-B subtype infected patients (240 weeks). These three groups of participants with HIV-1 infection were at first registered as three different studies: KAL1RO (this study, NCT01083810, n=137), KAL2RO /KAL5RO (NCT01083836, n=92), and KAL6RO (NCT01081470, n=55) but were now reconciled under KAL1RO (NCT01083810) as a single study with three reporting groups.

Conditions

Interventions

TypeNameDescription
DRUGLopinavir/Ritonavir (Kaletra)3 capsules 2xdaily or 2 tablets 2xdaily Kaletra

Timeline

Start date
2001-06-01
Primary completion
2010-06-01
Completion
2010-06-01
First posted
2010-03-10
Last updated
2011-08-11
Results posted
2011-07-29

Locations

90 sites across 1 country: Germany

Source: ClinicalTrials.gov record NCT01083810. Inclusion in this directory is not an endorsement.