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Kaletra and Maraviroc in Antiretroviral Therapy (ART)-Naive Patients (KALMAR Study) — KALMAR  

HIV Infections Clinical Trial

Official title:
Kaletra and Maraviroc in Antiretroviral Therapy-Naïve Patients - KALMAR Study -Version 1.0 Amendment 2

Clinical Trial Summary

The primary objective of this pilot study is to assess the efficacy of lopinavir/ritonavir (Kaletra, a protease inhibitor, PI) when used in combination with maraviroc (Selzentry, an HIV entry inhibitor) for the treatment of antiretroviral naïve HIV infected patients. Twenty patients will be enrolled and studied for 48 weeks.

Clinical Trial Description

As patients with HIV are living longer it is important to explore antiretroviral treatments which may reduce the development of long term complications while preserving future HIV treatment options. This trial explores an antiretroviral treatment regimen which does not include the nucleoside reverse transcriptase inhibitor class which is thought to have long-term toxicity. This is a non-randomized, open label trial in participants meeting entry requirements. Participants will be evaluated at screening, baseline,and weeks 4, 8, 12, 24, 36, and 48 to include clinical assessments as well as laboratory assessments. An interim analysis will be performed when all patients have reached the week 24 visit. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT01068873
Study type Interventional
Source Temple University
Contact
Status Terminated
Phase Phase 4
Start date April 2010
Completion date December 2010
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