Clinical trial NCT00443703: MK0518 in the Treatment of HIV-Infected Patients Switched From a Protease Inhibitor Regimen (0518-032)(TERMINATED)
Official title: A Multicenter, Double-Blind, Randomized, Active-Controlled Study to Evaluate the Safety and Antiretroviral Activity of MK0518 Versus KALETRA in HIV-Infected Patients Switched From a Stable KALETRA-Based Regimen - Study A
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: HIV Infection
Keywords: treatment experienced
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2007-03-06
Enrollment: 352
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: The purpose of this study is to investigate the efficacy, safety, and tolerability of an investigational treatment for patients with HIV.


Eligibility criteria: Inclusion Criteria:

* Patient is at least 18 years of age
* Patient is Human Immunodeficiency Virus (HIV) positive
* Patient has documented Human Immunodeficiency Virus (HIV) RiboNucleic Acid (RNA) \<50 copies/milliliter (mL) for at least 3 months while on a KALETRA based regimen
* Patient has been on a KALETRA based regimen for at least 3 months without a change in background antiretroviral therapy
* Patient has no documentation of HIV RNA \>50 copies/mL for at least 3 months while on the KALETRA based regimen

Exclusion Criteria:

* Patient is or plans to become pregnant, or nursing a child
* Patient plans to donate eggs or impregnate/donate sperm
* Patient is receiving Stavudine (d4T) as a component of the background antiretroviral therapy
* Patient is currently receiving a second protease inhibitor in addition to KALETRA
* Patient is currently receiving, or has received in the past twelve weeks, treatment for the management of elevated lipids
* Patient has used another experimental HIV-integrase inhibitor
* Patient has a current (active) diagnosis of acute hepatitis due to any cause
* Patient has used systemic immunosuppressive therapy within one month prior to treatment in this study

Primary outcomes:
measure: Number of Patients With Plasma Human Immunodeficiency Virus (HIV) RiboNucleic Acid (RNA) <50 Copies/mL at Week 24
timeFrame: Week 24
measure: Number of Patients With Clinical Adverse Experiences (CAEs) Through 24 Weeks
timeFrame: 24 Week last patient last visit
measure: Mean Percent Change From Baseline in Fasting Serum Cholesterol at Week 12
timeFrame: Baseline and Week 12
measure: Mean Percent Change From Baseline in Non-High-Density Lipoprotein Cholesterol (Non-HDL-C) at Week 12
timeFrame: Baseline and Week 12
measure: Mean Percent Change From Baseline in Fasting Serum Low-Density Lipoprotein Cholesterol (LDL-C) at Week 12
timeFrame: Baseline and Week 12
measure: Mean Percent Change From Baseline in Fasting Serum High-Density Lipoprotein Cholesterol (HDL-C) at Week 12
timeFrame: Baseline and Week 12
measure: Median Percent Change From Baseline in Serum Triglyceride at Week 12
timeFrame: Baseline and Week 12
Secondary outcomes:
measure: Mean Percent Change From Baseline in Fasting Serum Cholesterol at Week 24
timeFrame: Baseline and Week 24
measure: Mean Percent Change From Baseline in Non-High-Density Lipoprotein Cholesterol (Non-HDL-C) at Week 24
timeFrame: Baseline and Week 24
measure: Mean Percent Change From Baseline in Fasting Serum Low-Density Lipoprotein Cholesterol (LDL-C) at Week 24
timeFrame: Baseline and Week 24
measure: Mean Percent Change From Baseline in Fasting Serum High-Density Lipoprotein Cholesterol (HDL-C) at Week 24
timeFrame: Baseline and Week 24
measure: Median Percent Change From Baseline in Serum Triglyceride at Week 24
timeFrame: Baseline and Week 24
Other outcomes:
measure: Number of Patients With Serious CAEs Through 24 Weeks
timeFrame: 24 Week last patient last visit
measure: Number of Patients With Drug-related CAEs Through 24 Weeks
timeFrame: 24 Week last patient last visit
measure: Number of Patients With Serious Drug-related CAEs Through 24 Weeks
timeFrame: 24 Week last patient last visit
measure: Number of Patients That Died by 24 Week Last Patient Last Visit
timeFrame: 24 Week last patient last visit
measure: Number of Patients That Discontinued Due to CAEs Through 24 Weeks
timeFrame: 24 Week last patient last visit
measure: Number of Patients That Discontinued Due to Drug Related CAEs Through 24 Weeks
timeFrame: 24 Week last patient last visit
measure: Number of Patients With Laboratory Adverse Experiences (LAEs) Through 24 Weeks
timeFrame: 24 Week last patient last visit
measure: Number of Patients With Drug-related Laboratory Adverse Experiences (LAEs) Through 24 Weeks
timeFrame: 24 Week last patient last visit
measure: Number of Patients With Serious LAEs Through 24 Weeks
timeFrame: 24 Week last patient last visit
measure: Number of Patients That Discontinued Due to LAEs Through 24 Weeks
timeFrame: 24 Week last patient last visit
measure: Number of Patients That Discontinued With Drug Related LAEs Through 24 Weeks
timeFrame: 24 Week last patient last visit
Locations:
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Monitor
role: STUDY_DIRECTOR
References:
citation: Eron JJ, Young B, Cooper DA, Youle M, Dejesus E, Andrade-Villanueva J, Workman C, Zajdenverg R, Fatkenheuer G, Berger DS, Kumar PN, Rodgers AJ, Shaughnessy MA, Walker ML, Barnard RJ, Miller MD, Dinubile MJ, Nguyen BY, Leavitt R, Xu X, Sklar P; SWITCHMRK 1 and 2 investigators. Switch to a raltegravir-based regimen versus continuation of a lopinavir-ritonavir-based regimen in stable HIV-infected patients with suppressed viraemia (SWITCHMRK 1 and 2): two multicentre, double-blind, randomised controlled trials. Lancet. 2010 Jan 30;375(9712):396-407. doi: 10.1016/S0140-6736(09)62041-9. Epub 2010 Jan 12.