At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 351 enrolled
Drug / intervention
raltegravir potassium +1 moredrug
Likely dose
raltegravir potassium 400 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Multicenter, Double-Blind, Randomized, Placebo-Controlled Study to Evaluate the Safety and Antiretroviral Activity of MK-0518 in Combination With an Optimized Background Therapy (OBT), Versus Optimized Background Therapy Alone, in HIV-Infected Patients With Documented Resistance to at Least 1 Drug in Each of the 3 Classes of Licensed Oral Antiretroviral Therapies
In Brief
A Phase 3 clinical trial evaluating raltegravir potassium and Comparator: placebo for HIV Infections. Completed, enrolled 351 participants.
Detailed Summary
This study will investigate the safety and efficacy of raltegravir as a therapy for Human Immunodeficiency Virus (HIV)-infected patients failing current therapy with 3-class antiviral resistance.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHIV Infections
Countries--
Collaborators--
Timeline
Phase 3CompletedFinished
2006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartFeb 2006
First PostedFeb 2006
Primary CompletionOct 2007
Study CompletionMay 2011
TodayJul 2026
First PostedFeb 17, 2006
Enrollment StartFeb 1, 2006
Primary CompletionOct 1, 2007
Study CompletionMay 1, 2011
TodayJul 2, 2026
Enrollment to primary: 1.7 yearsPosted 20.4 years ago
Interventions
raltegravir potassiumdrug
Raltegravir 400 mg twice daily (b.i.d.) by mouth (p.o.) with optimized background therapy. Treatment period of 48 weeks.
Comparator: placebodrug
Placebo p.o. b.i.d. with optimized background therapy. Treatment period of 48 weeks.