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
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
1 other identifier
interventional
63
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_4 hiv
Started Dec 2010
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 26, 2010
CompletedFirst Posted
Study publicly available on registry
August 27, 2010
CompletedStudy Start
First participant enrolled
December 1, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2013
CompletedMay 13, 2013
May 1, 2013
2 years
August 26, 2010
May 10, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
48 weeks
Secondary Outcomes (5)
Proportion of patients with virological suppression
48 weeks
Proportion of patients with virological failure
48 week
Time to loss of virological response (TLOVR)
48 weeks
Change of CD4 cells count
48 weeks
Adverse events
48 weeks
Study Arms (2)
Boosted lopinavir monotherapy
EXPERIMENTALboosted lopinavir + optimized background regimens (OBRs)
ACTIVE COMPARATORInterventions
Lopinavir/ritonavir 200/50 mg every 12 hours
Optimized background regimens such as NRTIs, etravirine or raltegravir
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Bamrasnaradura Infectious Diseases Institute
Nonthaburi, 11000, Thailand
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Krittaecho Siripassorn, MD
Bamrasnaradura Infectious Diseases Institute
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER GOV
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Dr
Study Record Dates
First Submitted
August 26, 2010
First Posted
August 27, 2010
Study Start
December 1, 2010
Primary Completion
December 1, 2012
Study Completion
January 1, 2013
Last Updated
May 13, 2013
Record last verified: 2013-05