At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 206 enrolled
Drug / intervention
Comparator: MK0518 monotherapy +5 moredrug
Likely dose
MK0518 twice daily (dose range unspecified in interventions) for 48 weeks plus tenofovir 300 mg daily and lamivudine 300 mg dailyAI-extracted
Key inclusion· 2
- ✓HIV-positive status confirmed by testing
- ✓ART-naive or minimal prior therapy (<7 days total)
Key exclusion· 2
- ✕Age <18 years
- ✕HIV-negative status
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Multicenter, Double-Blind, Randomized, Dose Ranging Study to Compare the Safety and Activity of MK0518 Plus Tenofovir and Lamivudine (3TC) Versus Efavirenz Plus Tenofovir and Lamivudine (3TC) in ART-Naive, HIV-Infected Patients
In Brief
A Phase 2 clinical trial evaluating Comparator: MK0518 monotherapy, Comparator: MK0518 combination therapy, and 4 other interventions for HIV Infections and Acquired Immunodeficiency Syndrome. Completed, enrolled 206 participants.
Detailed Summary
This is a study that will investigate the safety and efficacy of an investigational drug in Human immunodeficiency virus (HIV) infected patients.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHIV Infections, Acquired Immunodeficiency Syndrome
Countries--
Collaborators--
Timeline
Phase 2CompletedFinished
20052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedDec 2004
Enrollment StartJan 2005
Primary CompletionOct 2006
Study CompletionJul 2010
TodayJul 2026
First PostedDec 23, 2004
Enrollment StartJan 1, 2005
Primary CompletionOct 1, 2006
Study CompletionJul 1, 2010
TodayJul 2, 2026
Enrollment to primary: 1.8 yearsPosted 21.5 years ago
Interventions
Comparator: MK0518 monotherapydrug
MK0518 twice daily for 10 days
Comparator: MK0518 combination therapydrug
MK0518 twice daily for 48 weeks
Comparator: efavirenzdrug
efavirenz 600 mg every night at bedtime for 48 weeks
Comparator: tenofovirdrug
tenofovir 300 mg daily for 48 weeks
Comparator: lamivudinedrug
lamivudine 300 mg daily for 48 weeks
Placebo monotherapydrug
Placebo to MK0518 twice daily