Status:
COMPLETED
Ritonavir-boosted Lopinavir Monotherapy
Lead Sponsor:
Bamrasnaradura Infectious Diseases Institute
Conditions:
HIV
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
To assess 48-week treatment responses, tolerability, and steady-state minimum plasma concentrations of ritonavir-boosted lopinavir monotherapy for salvage therapy in HIV-1 infected patients who failed...
Detailed Description
Currently, non-nucleoside reverse transcriptase inhibitor (NNRTI)-based highly active antiretroviral therapy (HAART) is widely prescribed as an initial therapy for treatment naïve HIV-infected patient...
Eligibility Criteria
Inclusion
- HIV-1 infected patients \>18 years of age,
- failed NNRTI-based antiretroviral therapy with M184V, thymidine analogue mutations (TAMs) and NNRTI-associated mutations
- had plasma HIV-1 RNA \>1,000 copies/mL.
Exclusion
- Had a history of exposure to protease inhibitor
- Receipt a medication that has drug-drug interactions with lopinavir.
Key Trial Info
Start Date :
April 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2011
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT01002898
Start Date
April 1 2007
End Date
February 1 2011
Last Update
November 11 2011
Active Locations (1)
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1
Bamrasnaradura Infectious Diseases Institute
Nonthaburi, Changwat Nonthaburi, Thailand, 11000