Status:
COMPLETED
Maintenance Boosted Lopinavir Monotherapy Following Salvage Protease-inhibitor (PI) Based Regimen in HIV With Non-nucleoside Reverse Transcriptase Inhibitors (NNRTI) Based Regimen Failure
Lead Sponsor:
Bamrasnaradura Infectious Diseases Institute
Collaborating Sponsors:
Department of Disease Control, Thailand
Conditions:
HIV
AIDS
Eligibility:
All Genders
18-60 years
Phase:
PHASE4
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 transcr...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
December 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2013
Estimated Enrollment :
63 Patients enrolled
Trial Details
Trial ID
NCT01189695
Start Date
December 1 2010
End Date
January 1 2013
Last Update
May 13 2013
Active Locations (1)
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1
Bamrasnaradura Infectious Diseases Institute
Nonthaburi, Thailand, 11000