A Multicenter, Double-Blind, Randomized, Active-Controlled Study to Evaluate the Safety and Antiretroviral Activity of MK-0518 Versus KALETRA™ in HIV-Infected Patients Switched from a Stable KALETRA™-Based Regimen - Study A Estudio Multicéntrico, doble ciego, randomizado y controlado con comparador activo, para evaluar la Seguridad y la Eficacia Antiretroviral del MK0518 frente a KALETRA™ en pacientes infectados con VIH y en tratamiento estable con KALETRA™ a los que se les cambia de tratamiento.
- Conditions
- HIV InfectionMedDRA version: 9.1 Level: LLT Classification code 10020161 Term: HIV infection
- Registration Number
- EUCTR2007-000783-25-ES
- Lead Sponsor
- Merck Sharp & Dohme de España, S.A.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Not specified
- Target Recruitment
- 340
1) Patient is a male or female at least 18 years of age on the day of signing the informed consent.
2) Patient is HIV positive as determined by enzyme-linked immunosorbent assay (ELISA) or HIV PCR.
3) Patient has documented HIV RNA <50 copies/mL for at least 3 months prior to study entry while on a KALETRA (dosed as 400 mg lopinavir/100 mg ritonavir twice daily) based regimen without a change in antiretroviral therapy and with no documentation of HIV RNA =50 copies/mL during this time.
4) Patient has no history of coronary artery disease.
5) Patient has the following laboratory values within 35 days prior to the treatment phase of this study:
a. Alkaline phosphatase = 5.0 x upper limit of normal
b. AST (SGOT) and ALT (SGPT) = 5.0 x upper limit of normal.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
1) Patient is receiving a KALETRA based regimen that includes Stavudine (d4T) as a component of the background antiretroviral therapy.
2) Patient is receiving a KALETRA based regimen that includes a second protease inhibitor in addition to KALETRA.
3) Patient is currently receiving, or has received in the past twelve weeks, agents known to have an effect on lipid levels (for example: fish oils, lipidol, bile-acid sequestrants, HMG-CoA reductase inhibitors [such as simvastatin, atorvastatin, rosuvastatin], ezetimibe, ezetimibe/simvastatin, fibrates, niacin, plant sterols, and/or red yeast).
4) Patient has a medical history which includes diabetes mellitus.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method