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Sponsors and Collaborators: |
University of South Florida Merck St. John's Research Institute |
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Information provided by: | University of South Florida |
ClinicalTrials.gov Identifier: | NCT00749580 |
The purpose of this study is to evaluate the safety and tolerability of raltegravir 400 mg b.i.d. compared with the NRTI backbone group, each in combination with a boosted PI regimen. Hypothesis: Raltegravir is generally safe and well tolerated compared with NRTIs in combination with a boosted PI regimen.
The purpose is to also evaluate the antiretroviral activity of raltegravir 400 mg b.i.d. versus the NRTI backbone, each in combination with a boosted-PI regimen, as measured by proportion of patients with viral load <75 copies/mL at Week 24.
Hypothesis: The proportion of patients with a viral load <75 copies/mL at Week 24 in the raltegravir 400 mg b.i.d. treatment group is non inferior to that of the NRTI treatment group, each in combination with a boosted PI regimen.
Condition | Intervention |
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Virologic Response |
Drug: Switch NRTIs as a Backbone to Raltegravir in HIV-Infected Patients from a Stable Boosted PI Regimen |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Pilot, Randomized, Controlled Study to Evaluate the Safety and Efficacy of Raltegravir Versus NRTIs as a Backbone in HIV-Infected Patients Switched From a Stable Boosted PI Regimen |
Estimated Enrollment: | 50 |
Study Start Date: | November 2008 |
Estimated Study Completion Date: | March 2011 |
Estimated Primary Completion Date: | March 2010 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental
Group 1 Raltegravir 400 mg PO b.i.d. + their current boosted PI regimen Group 2 Continue the same regimen without change
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Drug: Switch NRTIs as a Backbone to Raltegravir in HIV-Infected Patients from a Stable Boosted PI Regimen
This is a multicenter, pilot randomized, controlled study to evaluate the safety and efficacy of raltegravir in patients switched from a stable boosted PI-based regimen with a NRTI backbone to begin receiving raltegravir instead of their current NRTIs. A stable boosted PI-based regimen is defined as having a documented HIV RNA <75 copies/mL for ≥ 3 months prior to study entry without a change in background antiretroviral therapy and receiving a boosted PI-based regimen, dosed as per standard of care. Additionally, patients must not have had HIV RNA ≥ 75 copies/mL during the three months prior to study entry. Approximately 25 patients will be enrolled in the raltegravir treatment arm (Group 1) and approximately 25 patients in the continuation of the current NRTI backbone regimen treatment arm (Group 2). Patients will be randomly assigned 1:1 to a treatment group.
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2: No Intervention
Group 2 Continue the same regimen without change
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Ages Eligible for Study: | 18 Years to 80 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Patient has the following laboratory values within 35 days prior to the treatment phase of this study:
Exclusion Criteria:
Contact: Charurut Somboonwit, MD | 8133078015 ext 6460 | charurut_somboonwit@doh.stste.fl.us |
Contact: Mable Chow | 8133078015 ext 6460 | mable_chow@doh.state.fl.us |
United States, Florida | |
Hillsborough Health Depaetment Specialty Care Center | Recruiting |
Tampa, Florida, United States, 33602 | |
Contact: Mable Chow 813-307-8015 ext 6460 mable_chow@doh.state.fl.us |
Responsible Party: | USF Health ( Charurut Somboonwit, MD ) |
Study ID Numbers: | Merck-MK0518 |
Study First Received: | September 5, 2008 |
Last Updated: | February 19, 2009 |
ClinicalTrials.gov Identifier: | NCT00749580 History of Changes |
Health Authority: | United States: Institutional Review Board |
Safety |
HIV Infections Acquired Immunodeficiency Syndrome |