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

Bamrasnaradura Infectious Diseases Institute63 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

HIV AIDS Lopinavir Treatment Failure

Interventions

Eligibility

Sex: ALLMin age: 18 YearsMax age: 60 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Time to virological failure

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

Time frame: 48 weeks

Secondary Outcomes

Proportion of patients with virological suppression

virological suppression defined as having HIV-1 RNA \<40 copies/ml

Time frame: 48 weeks

Proportion of patients with virological failure

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

Time frame: 48 week

Time to loss of virological response (TLOVR)

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)

Time frame: 48 weeks

Change of CD4 cells count

Change of CD4 cells count from start of study to Week 48

Time frame: 48 weeks

Adverse events

any grade 3 or grade 4 adverse events according to DAIDS AE grading table

Time frame: 48 weeks

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

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes