NCT01189695

Maintenance Boosted Lopinavir Monotherapy Following Salvage Protease-inhibitor (PI) Based Regimen in HIV With Non-nucleoside Reverse Transcriptase Inhibitors (NNRTI) Based Regimen Failure

A Randomized Controlled Study Compares the 48 Weeks Results of HIV-1 RNA Between Ritonavir-boosted Lopinavir Monotherapy and Ritonavir-boosted Lopinavir + Optimized Background Regimens in HIV-1 Infected Patients Who Have HIV-1 RNA <50 Copies/ml More Than 6 Months While Receiving Salvage PI-based Regimen and Previously Failed NNRTI-based Regimen

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 63 (actual)
• Sponsor: Bamrasnaradura Infectious Diseases Institute · Other Government
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Not accepted

Summary

The objective of this study is to determine efficacy of ritonavir-boosted lopinavir monotherapy as a maintenance regimen in HIV-1-infected patients who previously failed Non-nucleoside reverse transcriptase inhibitors (NNRTI) based regimens and currently received salvage protease-inhibitor (PI) based regimens.

Conditions

• HIV
• AIDS
• Lopinavir
• Treatment Failure

Interventions

Type	Name	Description
DRUG	Ritonavir-boosted lopinavir	Lopinavir/ritonavir 200/50 mg every 12 hours
DRUG	optimized background regimens (OBRs)	Optimized background regimens such as NRTIs, etravirine or raltegravir

Timeline

• Start date: 2010-12-01
• Primary completion: 2012-12-01
• Completion: 2013-01-01
• First posted: 2010-08-27
• Last updated: 2013-05-13

Locations

1 site across 1 country: Thailand