At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 179 enrolled
Drug / intervention
Comparator: MK0518 +3 moredrug
Likely dose
MK0518 200 mg, 400 mg, or 600 mg orally twice daily for 24 weeksAI-extracted
Key inclusion· 2
- ✓HIV-positive with HIV RNA values within study-required ranges
- ✓Currently on antiretroviral therapy (ART)
Key exclusion· 1
- ✕Age less than 18 years
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Multicenter Study to Evaluate the Safety and Efficacy of MK0518 in Combination With An Optimized Background Therapy (OBT), Versus OBT Alone, in HIV-Infected Patients With Documented Resistance
In Brief
A Phase 2 clinical trial evaluating Comparator: MK0518, MK0518, and 1 other intervention for HIV Infections and Acquired Immunodeficiency Syndrome. Completed, enrolled 179 participants.
Detailed Summary
This study will investigate the safety and efficacy of different doses of an investigational drug (MK0518) as a therapy for HIV-infected patients failing current antiretroviral therapies.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHIV Infections, Acquired Immunodeficiency Syndrome
Countries--
Collaborators--
Timeline
Phase 2CompletedFinished
20052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartMar 2005
First PostedMar 2005
Primary CompletionOct 2006
Study CompletionJul 2009
TodayJul 2026
First PostedMar 9, 2005
Enrollment StartMar 1, 2005
Primary CompletionOct 1, 2006
Study CompletionJul 1, 2009
TodayJul 2, 2026
Enrollment to primary: 1.6 yearsPosted 21.3 years ago
Interventions
Comparator: MK0518drug
MK0518 oral tablets 200 mg b.i.d, for 24 weeks
MK0518drug
MK0518 oral tablets 400 mg b.i.d, for 24 weeks
MK0518drug
MK0518 oral tablets 600 mg b.i.d, for 24 weeks
Placebodrug
Placebo to MK0518, oral tablet b.i.d, for 24 weeks