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.
- Registry ID
- EUCTR2007-000783-25
- Source registry
- EUCTR
- Status
- Prematurely Ended
- Phase
- PHASE3
- Sponsor
- Merck Sharp & Dohme de España, S.A.
- Start date
- 2007-05-23
- Completion date
- 2009-04-21
- Last update
- 2026-08-16
Conditions
Summary
1) To evaluate the change in total cholesterol, triglycerides, non-HDL-C, and LDL-C associated with the use of MK-0518 400 mg b.i.d. compared with KALETRA 400/100 mg b.i.d., each in combination with background antiretroviral therapy, as measured by the mean percent change from baseline in total cholesterol, triglycerides, non-HDL-C, and LDL-C at Week 12. 2) To evaluate the antiretroviral activity of MK-0518 400 mg b.i.d. compared with KALETRA 400/100 mg b.i.d., each in combination with background antiretroviral therapy, as measured by proportion of patients with viral load <50 copies/mL at Week 24. 3) To evaluate the safety and tolerability of MK-0518 400 mg b.i.d. compared with KALETRA 400/100 mg b.i.d., each in combination with background antiretroviral therapy, as assessed by review of the accumulated safety data at Week 24.
Locations
- , , Germany
- , , UK
- , , Denmark
- , , Italy
- , , Portugal
- , , Spain
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