Clinical trial NCT00105157: Safety and Efficacy of an Investigational Drug in Human Immunodeficiency Virus (HIV)-Infected Patients Failing Current Antiretroviral Therapies (0518-005)(COMPLETED)
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: HIV Infections
Acquired Immunodeficiency Syndrome
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2005-03-09
Enrollment: 179
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Change From Baseline in Plasma HIV RNA (log10 Copies/mL) at Week 24
timeFrame: Baseline and Week 24
Secondary outcomes:
measure: Number of Patients With Virologic Responses at Week 24
timeFrame: 24 weeks
measure: Change From Baseline in CD4 Cell Count at Week 24
timeFrame: Baseline and Week 24
measure: Number of Patients With Clinical Adverse Experiences (CAEs) at 48 Weeks
timeFrame: 48 weeks
measure: Number of Patients With Serious CAEs at 48 Weeks
timeFrame: 48 weeks
measure: Number of Patients With Drug-related CAEs at 48 Weeks
timeFrame: 48 weeks
measure: Number of Patients With Serious Drug-related CAEs at 48 Weeks
timeFrame: 48 weeks
measure: Number of Patients That Died by 48 Weeks
timeFrame: 48 weeks
measure: Number of Patients That Discontinued With CAEs at 48 Weeks
timeFrame: 48 weeks
measure: Number of Patients That Discontinued With Drug-related CAEs at 48 Weeks
timeFrame: 48 weeks
measure: Number of Patients That Discontinued With Serious CAEs at 48 Weeks
timeFrame: 48 weeks
measure: Number of Patients That Discontinued With Serious Drug-related CAEs at 48 Weeks
timeFrame: 48 weeks
measure: Number of Patients With Laboratory Adverse Experiences (LAEs) at 48 Weeks
timeFrame: 48 weeks
measure: Number of Patients With Drug-related LAEs at 48 Weeks
timeFrame: 48 weeks
measure: Number of Patients Discontinued With Laboratory Adverse Experiences (LAEs) at 48 Weeks
timeFrame: 48 weeks
measure: Number of Patients Discontinued With Drug-related LAEs at 48 Weeks
timeFrame: 48 weeks
measure: Number of Patients With Clinical Adverse Experiences (CAEs) at 96 Weeks
timeFrame: 96 weeks
measure: Number of Patients With Serious CAEs at 96 Weeks
timeFrame: 96 weeks
measure: Number of Patients With Drug-related CAEs at 96 Weeks
timeFrame: 96 weeks
measure: Number of Patients With Serious Drug-related CAEs at 96 Weeks
timeFrame: 96 weeks
measure: Number of Patients That Died by 96 Weeks
timeFrame: 96 weeks
measure: Number of Patients That Discontinued With CAEs at 96 Weeks
timeFrame: 96 weeks
measure: Number of Patients That Discontinued With Drug-related CAEs at 96 Weeks
timeFrame: 96 weeks
measure: Number of Patients That Discontinued With Serious CAEs at 96 Weeks
timeFrame: 96 weeks
measure: Number of Patients That Discontinued With Serious Drug-related CAEs at 96 Weeks
timeFrame: 96 weeks
measure: Number of Patients With Laboratory Adverse Experiences (LAEs) at 96 Weeks
timeFrame: 96 weeks
measure: Number of Patients With Drug-related LAEs at 96 Weeks
timeFrame: 96 weeks
measure: Number of Patients Discontinued With Laboratory Adverse Experiences (LAEs) at 96 Weeks
timeFrame: 96 weeks
measure: Number of Patients Discontinued With Drug-related LAEs at 96 Weeks
timeFrame: 96 weeks
measure: Number of Patients With Clinical Adverse Experiences (CAEs) at 168 Weeks
timeFrame: 168 weeks
measure: Number of Patients With Serious CAEs at 168 Weeks
timeFrame: 168 weeks
measure: Number of Patients With Drug-related CAEs at 168 Weeks
timeFrame: 168 weeks
measure: Number of Patients With Serious Drug-related CAEs at 168 Weeks
timeFrame: 168 weeks
measure: Number of Patients That Died by 168 Weeks
timeFrame: 168 weeks
measure: Number of Patients That Discontinued With CAEs at 168 Weeks
timeFrame: 168 weeks
measure: Number of Patients That Discontinued With Drug-related CAEs at 168 Weeks
timeFrame: 168 weeks
measure: Number of Patients That Discontinued With Serious CAEs at 168 Weeks
timeFrame: 168 weeks
measure: Number of Patients That Discontinued With Serious Drug-related CAEs at 168 Weeks
timeFrame: 168 weeks
measure: Number of Patients With Laboratory Adverse Experiences (LAEs) at 168 Weeks
timeFrame: 168 weeks
measure: Number of Patients With Serious LAEs at 168 Weeks
timeFrame: 168 weeks
measure: Number of Patients Discontinued With Drug-related LAEs at 168 Weeks
timeFrame: 168 weeks
measure: Number of Patients With Drug-related LAEs at 168 Weeks
timeFrame: 168 weeks
measure: Number of Patients With Serious Drug-related LAEs at 168 Weeks
timeFrame: 168 weeks
measure: Number of Patients Discontinued With LAEs at 168 Weeks
timeFrame: 168 weeks
Other outcomes:
measure: Change From Baseline in Plasma HIV RNA (log10 Copies/mL) at Week 168 in Combined Substudies
timeFrame: Baseline and Week 168
measure: Change From Baseline in CD4 Cell Count at Week 168 in Combined Substudies
timeFrame: Baseline and Week 168
Locations:
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Monitor
role: STUDY_DIRECTOR
References:
citation: Grinsztejn B, Nguyen BY, Katlama C, Gatell JM, Lazzarin A, Vittecoq D, Gonzalez CJ, Chen J, Harvey CM, Isaacs RD; Protocol 005 Team. Safety and efficacy of the HIV-1 integrase inhibitor raltegravir (MK-0518) in treatment-experienced patients with multidrug-resistant virus: a phase II randomised controlled trial. Lancet. 2007 Apr 14;369(9569):1261-1269. doi: 10.1016/S0140-6736(07)60597-2.