A Phase III Multicenter, Double-Blind, Randomized, Active Comparator-Controlled Clinical Trial to Study the Safety and Efficacy of Once Daily Raltegravir (MK-0518) Versus Twice Daily Raltegravir, Each in Combination With TRUVADA™, in Treatment-Naïve HIV Infected Patients - Safety and efficacy of once daily raltegravir compared to twice daily raltegravir

• Conditions: HIV infection; MedDRA version: 11Level: PTClassification code 10020161Term: <Manually entered code. Term in E.1.1>

• Registration Number: EUCTR2008-002733-70-NL
• Lead Sponsor: MSD BV

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2008-11-28
• Last Update Posted: 24 April 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 750

Inclusion Criteria

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 a positive result by enzyme-linked immunosorbent assay (ELISA) and has screening plasma HIV RNA (determined by the central laboratory) >5000 copies/mL within 45 days prior to the treatment phase of this study, and is indicated for treatment based on physician assessment. Local treatment guidelines should be considered in the decision to initiate therapy.
3. Patient is naïve to antiretroviral therapy (ART), defined as having received <7 days total of any ART and no ART within the 45 days prior to the treatment phase of this study.
4. Patient has the following laboratory values within 45 days prior to the treatment phase of this study:
4.1 Serum creatinine =2.0 x upper limit of normal
4.2 Alkaline phosphatase =5.0 x upper limit of normal
4.3 AST (SGOT) and ALT (SGPT) =5.0 x upper limit of normal
5. Patient has a calculated creatinine clearance at time of screening >30 mL/min
6. Patient who is of reproductive potential agrees remain abstinent or use (or have their partner use) 2 acceptable methods of birth control throughout the study.
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

Exclusion Criteria

1. Patient has documented resistance to tenofovir, and/or emtricitabine.
2. Patient has used another experimental HIV-integrase inhibitor.
3. Patient has a current (active) diagnosis of acute hepatitis due to any cause. Patients with chronic hepatitis, including chronic hepatitis B and/or C, may enter the study as long as they have stable liver function tests, no significant impairment of hepatic synthetic function (significant impairment of hepatic synthetic function is defined as a serum albumin <2.8 mg/dL or an INR >1.7 in the absence of another explanation for the abnormal laboratory value) and meet all other inclusion criteria.
4. Patient is pregnant or breastfeeding, or expecting to conceive (within the duration of the study). Patient is expecting to donate eggs (within the duration of the study). Patient is expecting to donate sperm (within the duration of the study).

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified