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

May 10, 2013 updated by: Krittaecho Siripassorn, Bamrasnaradura Infectious Diseases Institute

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

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 Overview

Study Type

Interventional

Enrollment (Actual)

63

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Nonthaburi, Thailand, 11000
        • Bamrasnaradura Infectious Diseases Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Boosted lopinavir monotherapy
Lopinavir/ritonavir 200/50 mg every 12 hours
ACTIVE_COMPARATOR: boosted lopinavir + optimized background regimens (OBRs)
Lopinavir/ritonavir 200/50 mg every 12 hours
Optimized background regimens such as NRTIs, etravirine or raltegravir

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time to virological failure
Time Frame: 48 weeks
virological failure was defined as having two consecutive results of HIV-1 RNA >400 copies/ml in time separated by 4 weeks
48 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Proportion of patients with virological suppression
Time Frame: 48 weeks
virological suppression defined as having HIV-1 RNA <40 copies/ml
48 weeks
Proportion of patients with virological failure
Time Frame: 48 week
virological failure was defined as having two consecutive results of HIV-1 RNA >400 copies/ml in time separated by 4 weeks
48 week
Time to loss of virological response (TLOVR)
Time Frame: 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)
48 weeks
Change of CD4 cells count
Time Frame: 48 weeks
Change of CD4 cells count from start of study to Week 48
48 weeks
Adverse events
Time Frame: 48 weeks
any grade 3 or grade 4 adverse events according to DAIDS AE grading table
48 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2010

Primary Completion (ACTUAL)

December 1, 2012

Study Completion (ACTUAL)

January 1, 2013

Study Registration Dates

First Submitted

August 26, 2010

First Submitted That Met QC Criteria

August 26, 2010

First Posted (ESTIMATE)

August 27, 2010

Study Record Updates

Last Update Posted (ESTIMATE)

May 13, 2013

Last Update Submitted That Met QC Criteria

May 10, 2013

Last Verified

May 1, 2013

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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