NCT00752037

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

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: Saint Michael's Medical Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Detailed 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.

Conditions

• HIV Infections

Interventions

Type	Name	Description
DRUG	lopinavir/ritonavir and raltegravir	lopinavir/ritonavir 400/100 mg po b.id. in combination with raltegravir 400 mg po b.i.d.

Timeline

• Start date: 2008-09-01
• Primary completion: 2010-04-01
• Completion: 2010-06-01
• First posted: 2008-09-15
• Last updated: 2011-07-20

Locations

1 site across 1 country: United States