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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)

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ClinicalTrials.gov Identifier: NCT01189695
Recruitment Status : Completed
First Posted : August 27, 2010
Last Update Posted : May 13, 2013
Information provided by (Responsible Party):

Study Description
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.

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

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 63 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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
Study Start Date : December 2010
Primary Completion Date : December 2012
Study Completion Date : January 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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

Outcome Measures

Primary Outcome Measures :
  1. 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

Secondary Outcome Measures :
  1. Proportion of patients with virological suppression [ Time Frame: 48 weeks ]
    virological suppression defined as having HIV-1 RNA <40 copies/ml

  2. 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

  3. 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)

  4. Change of CD4 cells count [ Time Frame: 48 weeks ]
    Change of CD4 cells count from start of study to Week 48

  5. Adverse events [ Time Frame: 48 weeks ]
    any grade 3 or grade 4 adverse events according to DAIDS AE grading table

Eligibility Criteria

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01189695

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

Responsible Party: Krittaecho Siripassorn, Dr, Bamrasnaradura Infectious Diseases Institute
ClinicalTrials.gov Identifier: NCT01189695     History of Changes
Other Study ID Numbers: BIDI-MONO
First Posted: August 27, 2010    Key Record Dates
Last Update Posted: May 13, 2013
Last Verified: May 2013

Keywords provided by Krittaecho Siripassorn, Bamrasnaradura Infectious Diseases Institute:
Anti-Retroviral Agents
treatment failure
treatment experienced
NNRTI failure

Additional relevant MeSH terms:
Protease Inhibitors
Reverse Transcriptase Inhibitors
HIV Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-HIV Agents
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
Cytochrome P-450 CYP3A Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Nucleic Acid Synthesis Inhibitors