A Trial to Determine the Long-term Durability of Virologic Suppression in Kaletra Recipients With Imperfect Adherence

Phase 4

Completed

• Conditions: HIV Infection

• Registration Number: NCT00785616
• Lead Sponsor: Montefiore Medical Center

Brief Summary

This study will enroll completers of a prior 24 week MEMS cap study of Kaletra adherence, conducted in 2005 - 2006, and repeat the MEMS monitoring for an additional 24 weeks in 2008/2009 on the current antiretroviral anchor drug. The goals of the study are to correlate long-term adherence with virologic outcome, and to explore the stability of MEMS cap adherence measurements over time.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-09
• Study First Submitted: 2008-11-04
• Study First Submitted QC: 2008-11-04
• Study First Posted: 2008-11-05
• Primary Completion: 2009-08
• Study Completion: 2009-10
• Status Verified: 2018-04
• Last Update Submitted: 2018-04-25
• Last Update Posted: 2018-04-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 55

Inclusion Criteria

• Participation in the prior Kaletra MEMS cap study

Exclusion Criteria

• Not receiving antiretroviral therapy, refusal to provide informed consent

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Proportion with virologic suppression	24 weeks

Trial Locations

Locations (1)

Montefiore Medical Center; 🇺🇸 Bronx, New York, United States