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)

This study has been completed.
Sponsor:
Collaborator:
Department of Disease Control, Thailand
Information provided by (Responsible Party):
Krittaecho Siripassorn, Bamrasnaradura Infectious Diseases Institute
ClinicalTrials.gov Identifier:
NCT01189695
First received: August 26, 2010
Last updated: May 10, 2013
Last verified: May 2013
  Purpose

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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Bamrasnaradura Infectious Diseases Institute:

Primary Outcome Measures:
  • Time to virological failure [ Time Frame: 48 weeks ] [ Designated as safety issue: Yes ]
    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 [ Time Frame: 48 weeks ] [ Designated as safety issue: Yes ]
    virological suppression defined as having HIV-1 RNA <40 copies/ml

  • Proportion of patients with virological failure [ Time Frame: 48 week ] [ Designated as safety issue: Yes ]
    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) [ Time Frame: 48 weeks ] [ Designated as safety issue: Yes ]
    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 [ Time Frame: 48 weeks ] [ Designated as safety issue: No ]
    Change of CD4 cells count from start of study to Week 48

  • Adverse events [ Time Frame: 48 weeks ] [ Designated as safety issue: Yes ]
    any grade 3 or grade 4 adverse events according to DAIDS AE grading table


Enrollment: 63
Study Start Date: December 2010
Study Completion Date: January 2013
Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01189695

Locations
Thailand
Bamrasnaradura Infectious Diseases Institute
Nonthaburi, Thailand, 11000
Sponsors and Collaborators
Bamrasnaradura Infectious Diseases Institute
Department of Disease Control, Thailand
Investigators
Principal Investigator: Krittaecho Siripassorn, MD Bamrasnaradura Infectious Diseases Institute
  More Information

No publications provided

Responsible Party: Krittaecho Siripassorn, Dr, Bamrasnaradura Infectious Diseases Institute
ClinicalTrials.gov Identifier: NCT01189695     History of Changes
Other Study ID Numbers: BIDI-MONO
Study First Received: August 26, 2010
Last Updated: May 10, 2013
Health Authority: Thailand: Ministry of Public Health

Keywords provided by Bamrasnaradura Infectious Diseases Institute:
HIV or AIDS
Lopinavir
Ritonavir
Anti-Retroviral Agents
treatment failure
treatment experienced
NNRTI failure
monotherapy

Additional relevant MeSH terms:
Ritonavir
Lopinavir
Reverse Transcriptase Inhibitors
HIV Protease Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Anti-HIV Agents
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Nucleic Acid Synthesis Inhibitors

ClinicalTrials.gov processed this record on September 18, 2014