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

Montefiore Medicine Academic Health System

Status and phase: Completed; Phase 4

Conditions: HIV Infection

Treatments: Other: MEMS cap monitoring

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00785616

08-03086E

Details and patient eligibility

About

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.

Enrollment: 55 estimated patients

Sex: All

Ages: 19+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Participation in the prior Kaletra MEMS cap study

Exclusion criteria

• Not receiving antiretroviral therapy, refusal to provide informed consent

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)