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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

August 26, 2010
May 10, 2013
December 2010
December 2012   (final data collection date for primary outcome measure)
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
Same as current
Complete list of historical versions of study NCT01189695 on ClinicalTrials.gov Archive Site
  • 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
Same as current
Not Provided
Not Provided
 
Maintenance Boosted Lopinavir Monotherapy Following Salvage Protease-inhibitor (PI) Based Regimen in HIV With Non-nucleoside Reverse Transcriptase Inhibitors (NNRTI) Based Regimen Failure
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.

Not Provided
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • HIV
  • AIDS
  • Lopinavir
  • Treatment Failure
  • 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
  • Experimental: Boosted lopinavir monotherapy
    Intervention: Drug: Ritonavir-boosted lopinavir
  • Active Comparator: boosted lopinavir + optimized background regimens (OBRs)
    Interventions:
    • Drug: Ritonavir-boosted lopinavir
    • Drug: optimized background regimens (OBRs)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
63
January 2013
December 2012   (final data collection date for primary outcome measure)

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
Both
18 Years to 60 Years
No
Contact information is only displayed when the study is recruiting subjects
Thailand
 
NCT01189695
BIDI-MONO
No
Krittaecho Siripassorn, Bamrasnaradura Infectious Diseases Institute
Bamrasnaradura Infectious Diseases Institute
Department of Disease Control, Thailand
Principal Investigator: Krittaecho Siripassorn, MD Bamrasnaradura Infectious Diseases Institute
Bamrasnaradura Infectious Diseases Institute
May 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP