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

Phase 4

Completed

• Conditions: HIV; AIDS; Lopinavir; Treatment Failure
• Interventions: Drug: Ritonavir-boosted lopinavir; Drug: optimized background regimens (OBRs)

• Registration Number: NCT01189695
• Lead Sponsor: Bamrasnaradura Infectious Diseases Institute

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2010-08-26
• Study First Submitted QC: 2010-08-26
• Study First Posted: 2010-08-27
• Study Start: 2010-12
• Primary Completion: 2012-12
• Study Completion: 2013-01
• Status Verified: 2013-05
• Last Update Submitted: 2013-05-10
• Last Update Posted: 2013-05-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 63

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Boosted lopinavir monotherapy	Ritonavir-boosted lopinavir	-
boosted lopinavir + optimized background regimens (OBRs)	Ritonavir-boosted lopinavir	-
boosted lopinavir + optimized background regimens (OBRs)	optimized background regimens (OBRs)	-

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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

Trial Locations

Locations (1)

Bamrasnaradura Infectious Diseases Institute; 🇹🇭 Nonthaburi, Thailand