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Safety Study of Lopinavir/Ritonavir With Raltegravir in HIV-infected Patients

HIV Infections Clinical Trial

Official title:
Safety and Efficacy of Lopinavir/Ritonavir in Combination With Raltegravir in HIV-infected Patients

Clinical Trial Summary

A single center, open label, 48-week study of lopinavir/ritonavir in combination with raltegravir. 30 patients, both naïve and experienced, will be enrolled. 15 treatment naïve patients and 15 treatment experienced patients enrolled

Clinical Trial Description

This is an open-labeled, non-randomized exploratory trial in selected volunteers who meet the stated enrollment criteria. This study will assess the impact of lopinavir/ritonavir in combination with raltegravir on HIV-1

Patients will be evaluated frequently over the 52 weeks of the protocol. Patients will be seen at screening, baseline, week 4, 12, 24, 36, 48, and 52, to include physical examination, assessment for the development of AIDS-defining conditions, hematology, chemistry, lipid profile, CD4, CD8 cell counts, plasma HIV-1 RNA ultrasensitive, and assessment of adverse events. If HIV-1 RNA becomes detectable, this will be repeated for confirmation with 2 weeks. HIV genotyping and phenotyping will be performed on patients who demonstrate repetitive plasma viral load levels of > 1,000 copies/mL.

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 NCT00752037
Study type Interventional
Source Saint Michael's Medical Center
Contact
Status Completed
Phase Phase 4
Start date September 2008
Completion date June 2010
View Details
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