Ritonavir-boosted Lopinavir Monotherapy

This study has been completed.
Sponsor:
Information provided by:
Bamrasnaradura Infectious Diseases Institute
ClinicalTrials.gov Identifier:
NCT01002898
First received: October 27, 2009
Last updated: November 10, 2011
Last verified: October 2009

October 27, 2009
November 10, 2011
April 2007
February 2011   (final data collection date for primary outcome measure)
To assess 48-week treatment responses of ritonavir-boosted lopinavir (LPV/r) monotherapy as salvage regimen. [ Time Frame: 48 weeks ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01002898 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
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Ritonavir-boosted Lopinavir Monotherapy
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

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.

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.

Interventional
Phase 3
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
HIV
Drug: lopinavir/ritonavir soft gel capsule
Ritonavir-boosted lopinavir in soft gel formulation at 400/100 mg and lamivudine at 150 mg were given twice daily.
Other Name: Kaletra
Experimental: lopinavir/ritonavir
Intervention: Drug: lopinavir/ritonavir soft gel capsule
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
40
February 2011
February 2011   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Thailand
 
NCT01002898
4/2551
Yes
Bamrasnaradura Infectious Diseases Institute
Bamrasnaradura Infectious Diseases Institute
Not Provided
Not Provided
Bamrasnaradura Infectious Diseases Institute
October 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP