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 (BIDI-MONO)

NCT01189695 Phase 4 COMPLETED

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.

Details

Lead sponsor	Bamrasnaradura Infectious Diseases Institute
Phase	Phase 4
Status	COMPLETED
Enrolment	63
Start date	2010-12
Completion	2013-01

Conditions

• HIV
• AIDS
• Lopinavir
• Treatment Failure

Interventions

• Ritonavir-boosted lopinavir
• optimized background regimens (OBRs)

Primary outcomes

• Time to virological failure — 48 weeks
  virological failure was defined as having two consecutive results of HIV-1 RNA \>400 copies/ml in time separated by 4 weeks

Countries

Thailand