NCT00105157CompletedPhase 2
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
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- Merck Sharp & Dohme LLC
- Enrollment
- 179
- Primary Endpoint
- Change From Baseline in Plasma HIV RNA (log10 Copies/mL) at Week 24
Study Overview
Brief 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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Patient must be HIV positive with Human Immunodeficiency Virus (HIV) Ribonucleic Acid (RNA) values that are within ranges required by the study
- •Patient must be currently on antiretroviral therapy (ART)
Exclusion Criteria
- •Patient less than 18 years of age
- •Additional exclusion criteria will be discussed and identified by the study doctor
Arms & Interventions
2
Experimental
MK0518 400 mg
Intervention: MK0518 (Drug)
3
Experimental
MK0518 600 mg
Intervention: MK0518 (Drug)
4
Placebo Comparator
Placebo
Intervention: Placebo (Drug)
Outcomes
Primary Outcomes
Change From Baseline in Plasma HIV RNA (log10 Copies/mL) at Week 24
Time Frame: Baseline and Week 24
Mean change from baseline at Week 24 in HIV RNA (log10 copies/mL) in all patients
Secondary Outcomes
- Number of Patients That Died by 48 Weeks(48 weeks)
- Number of Patients That Discontinued With CAEs at 48 Weeks(48 weeks)
- Change From Baseline in CD4 Cell Count at Week 24(Baseline and Week 24)
- Number of Patients With Drug-related LAEs at 168 Weeks(168 weeks)
- Number of Patients With Serious Drug-related CAEs at 96 Weeks(96 weeks)
- Number of Patients With Laboratory Adverse Experiences (LAEs) at 168 Weeks(168 weeks)
- Number of Patients Discontinued With Laboratory Adverse Experiences (LAEs) at 48 Weeks(48 weeks)
- Number of Patients With Serious CAEs at 96 Weeks(96 weeks)
- Number of Patients With Virologic Responses at Week 24(24 weeks)
- Number of Patients With Serious CAEs at 48 Weeks(48 weeks)
- Number of Patients That Discontinued With Serious CAEs at 48 Weeks(48 weeks)
- Number of Patients That Discontinued With Serious Drug-related CAEs at 48 Weeks(48 weeks)
- Number of Patients That Discontinued With Serious CAEs at 96 Weeks(96 weeks)
- Number of Patients Discontinued With Laboratory Adverse Experiences (LAEs) at 96 Weeks(96 weeks)
- Number of Patients With Drug-related CAEs at 168 Weeks(168 weeks)
- Number of Patients That Discontinued With Serious CAEs at 168 Weeks(168 weeks)
- Number of Patients That Discontinued With Serious Drug-related CAEs at 168 Weeks(168 weeks)
- Number of Patients Discontinued With LAEs at 168 Weeks(168 weeks)
- Number of Patients That Discontinued With Drug-related CAEs at 168 Weeks(168 weeks)
- Number of Patients With Clinical Adverse Experiences (CAEs) at 48 Weeks(48 weeks)
- Number of Patients With Drug-related CAEs at 48 Weeks(48 weeks)
- Number of Patients With Serious Drug-related CAEs at 48 Weeks(48 weeks)
- Number of Patients That Discontinued With Drug-related CAEs at 48 Weeks(48 weeks)
- Number of Patients With Laboratory Adverse Experiences (LAEs) at 48 Weeks(48 weeks)
- Number of Patients Discontinued With Drug-related LAEs at 48 Weeks(48 weeks)
- Number of Patients With Laboratory Adverse Experiences (LAEs) at 96 Weeks(96 weeks)
- Number of Patients That Discontinued With CAEs at 168 Weeks(168 weeks)
- Number of Patients With Drug-related LAEs at 48 Weeks(48 weeks)
- Number of Patients With Clinical Adverse Experiences (CAEs) at 96 Weeks(96 weeks)
- Number of Patients That Discontinued With Serious Drug-related CAEs at 96 Weeks(96 weeks)
- Number of Patients With Drug-related LAEs at 96 Weeks(96 weeks)
- Number of Patients Discontinued With Drug-related LAEs at 96 Weeks(96 weeks)
- Number of Patients With Clinical Adverse Experiences (CAEs) at 168 Weeks(168 weeks)
- Number of Patients With Serious Drug-related CAEs at 168 Weeks(168 weeks)
- Number of Patients Discontinued With Drug-related LAEs at 168 Weeks(168 weeks)
- Number of Patients With Drug-related CAEs at 96 Weeks(96 weeks)
- Number of Patients That Died by 96 Weeks(96 weeks)
- Number of Patients That Discontinued With CAEs at 96 Weeks(96 weeks)
- Number of Patients That Discontinued With Drug-related CAEs at 96 Weeks(96 weeks)
- Number of Patients With Serious CAEs at 168 Weeks(168 weeks)
- Number of Patients That Died by 168 Weeks(168 weeks)
- Number of Patients With Serious LAEs at 168 Weeks(168 weeks)
- Number of Patients With Serious Drug-related LAEs at 168 Weeks(168 weeks)
Investigators
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