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

April 25, 2018 updated by: Jonathan Shuter, Montefiore Medical Center

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.

Study Overview

Status

Completed

Conditions

HIV Infection

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

Phase

Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

United States
- New York
  - Bronx, New York, United States, 10467
    - Montefiore Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Genders Eligible for Study

All

Description

Inclusion Criteria:

Participation in the prior Kaletra MEMS cap study

Exclusion Criteria:

Not receiving antiretroviral therapy, refusal to provide informed consent

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Primary Purpose: Treatment
Allocation: N/A
Interventional Model: Single Group Assignment
Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Proportion with virologic suppression Time Frame: 24 weeks	24 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Montefiore Medical Center

Collaborators

Abbott

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2008

Primary Completion (Actual)

August 1, 2009

Study Completion (Actual)

October 1, 2009

Study Registration Dates

First Submitted

November 4, 2008

First Submitted That Met QC Criteria