Ritonavir-boosted Lopinavir Monotherapy
Information source: Bamrasnaradura Infectious Diseases Institute
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: HIV
Intervention: lopinavir/ritonavir soft gel capsule (Drug)
Phase: Phase 3
Status: Completed
Sponsored by: Bamrasnaradura Infectious Diseases Institute
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 antiretroviral regimens containing NRTI and NNRTI.
Clinical Details
Official title: Treatment Outcomes and Plasma Level of Ritonavir-boosted Lopinavir Monotherapy Among HIV-infected Patients Who Had Non-nucleoside Reverse Transcriptase Inhibitor (NRTI) and NNRTI Failure: A Pilot Study
Study design: Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: To assess 48-week treatment responses of ritonavir-boosted lopinavir (LPV/r) monotherapy as salvage regimen.
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 patients, particularly in many resource-constrained countries. However,
in patients who have delayed detection of treatment failure in this setting, the virus is
often resistant to most existing nucleoside reverse transcriptase inhibitors (NRTIs) and
NNRTIs even failing from the first regimen. As a consequence, constructing the potent
salvage regimens that combined 2 or 3 fully active drugs from existing drug classes is often
impossible in many resource-constrained countries where new agents, such as integrase
inhibitor and chemokine receptor antagonist, are neither available nor affordable.
Nevertheless, the goal of attaining undetectable plasma HIV-1 RNA is remain mandatory. To
date, several clinical studies derived from the western countries that included 2 or more
active drugs clearly demonstrate effective therapeutic strategies for antiretroviral
(ARV)-experienced HIV-1 infected patients. Hence, using ritonavir-boosted protease inhibitor
in a salvage therapy was considered to be an option in the resource-constrained countries
and the limitations of remaining active NRTIs usually lead to ritonavir-boosted protease
inhibitor monotherapy as a salvage regimen.
Among several previous reports using ritonavir-boosted protease inhibitor, ritonavir-boosted
lopinavir monotherapy has been extensively studied so far. Different strategies of
ritonavir-boosted lopinavir monotherapy have been explored; however, most related clinical
trials studied this regimen as either a treatment simplification strategy or induction
therapy in treatment-naïve patients. A strategy to use ritonavir-boosted lopinavir
monotherapy as a salvage regimen is not available. On the other hand, previous studies
showed that continuation of lamivudine after emerging of the M184V mutation had somewhat
benefit on immunological response and clinical progression in patients who had limited
options of salvage regimens. Moreover, there is neither additional any other mutation nor
increase resistance to other antiretroviral drugs. Thus, this is the reason why we added
lamivudine to decrease viral fitness in the study regimen. The objective of this study was
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 antiretroviral regimens containing NRTI and NNRTI.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria:
1. HIV-1 infected patients >18 years of age,
2. failed NNRTI-based antiretroviral therapy with M184V, thymidine analogue mutations
(TAMs) and NNRTI-associated mutations
3. had plasma HIV-1 RNA >1,000 copies/mL.
Exclusion Criteria:
1. Had a history of exposure to protease inhibitor
2. Receipt a medication that has drug-drug interactions with lopinavir.
Locations and Contacts
Bamrasnaradura Infectious Diseases Institute, Nonthaburi 11000, Thailand
Additional Information
Starting date: April 2007
Last updated: November 10, 2011
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