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

Sponsor

Bamrasnaradura Infectious Diseases Institute (Other)

Overall Status

Completed

CT.gov ID

NCT01189695

Collaborator

Department of Disease Control, Thailand (Other)

Enrollment

Location

Arms

Duration (Months)

2.5

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
HIV AIDS Lopinavir Treatment Failure	Drug: Ritonavir-boosted lopinavir Drug: optimized background regimens (OBRs)	Phase 4

Study Design

Study Type:

Interventional

Actual Enrollment :

63 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Dec 1, 2010

Actual Primary Completion Date :

Dec 1, 2012

Actual Study Completion Date :

Jan 1, 2013

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Boosted lopinavir monotherapy	Drug: Ritonavir-boosted lopinavir Lopinavir/ritonavir 200/50 mg every 12 hours
Active Comparator: boosted lopinavir + optimized background regimens (OBRs)	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

Arm

Intervention/Treatment

Experimental: Boosted lopinavir monotherapy

Drug: Ritonavir-boosted lopinavir

Lopinavir/ritonavir 200/50 mg every 12 hours

Active Comparator: boosted lopinavir + optimized background regimens (OBRs)

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

Outcome Measures

Primary Outcome Measures

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

Secondary Outcome Measures

Proportion of patients with virological suppression [48 weeks]
virological suppression defined as having HIV-1 RNA <40 copies/ml
Proportion of patients with virological failure [48 week]
virological failure was defined as having two consecutive results of HIV-1 RNA >400 copies/ml in time separated by 4 weeks
Time to loss of virological response (TLOVR) [48 weeks]
TLOVR was defined as time between randomization and the last value that HIV-1 RNA <40 copies/ml in a patient who initially suppressed HIV-1 RNA but subsequently demonstrated virologic rebound (two consecutive HIV-1 RNA >40 copies/ml)
Change of CD4 cells count [48 weeks]
Change of CD4 cells count from start of study to Week 48
Adverse events [48 weeks]
any grade 3 or grade 4 adverse events according to DAIDS AE grading table

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 60 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

age 18-60 years
documented HIV infection
previously failed to NNRTI-based regimens
no history of failing PI-based regimens
receiving ritonavir-boosted PI + OBRs(such as NRITs, etravirine, raltegravir)
having HIV-1 RNA <50 copies/ml for at least prior 6 months

Exclusion Criteria:

Pregnant or breastfeeding woman
HBV co-infection that had to treated with TDF, FTC or 3TC
had to received medications known to have potential significant drug interaction with LPV/r
life expectancy less than 6 months
serious systemic diseases such as liver cirrhosis Child-Pugh B/C, ESRD, malignancy
hemoglobin <8 g/dl, platelet <50,000/mm3, AST or ALT >3 ULN, estimated creatinine clearance <50 mL/min