A Study to Determine the Safety and Efficacy of Once Daily Raltegravir Compared to Twice Daily Raltegravir (MK-0518-071)

Merck Sharp & Dohme (MSD)

Status and phase

Terminated

Phase 3

Conditions

HIV

Treatments

Drug: TRUVADA™

Drug: Experimental: Raltegravir 800 mg q.d.

Drug: Comparator: Raltegravir 400 mg b.i.d.

Study type

Interventional

Funder types

Industry

Identifiers

NCT00745823

0518-071

2008_543 (Other Identifier)

CTRI/2009/091/000145 (Registry Identifier)

Details and patient eligibility

About

A study to evaluate the safety, tolerability and efficacy of once daily Raltegravir compared to twice daily raltegravir when each is given in combination with TRUVADA™ in treatment-naïve human immunodeficiency virus (HIV)-infected patients.

Full description

Following the 96-week double-blind study period (MK0518-071)(NCT00745823), subjects may enroll in an extension study (MK0518-071-10)(NCT00745823). From weeks 96 to 120, subjects' treatment assignments will remain as in the base study.

From week 120 to 240, all subjects will receive open-label raltegravir (800 mg, once daily) in combination with TRUVADA™.

Enrollment

775 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Patient is male or female 18 years of age or older
Patient is HIV positive
Patient is naïve to antiretroviral therapy (ART) or has received less than 7 days total of any ART

Extension Study:

The planned extension study did not take place as the study was terminated after the Week 48 analysis.

Exclusion criteria

Patient is a user of recreational or illicit drugs or has had a recent history (within the last year) of drug or alcohol abuse or dependence
Patient has documented resistance to tenofovir or emtricitabine
Patient is currently participating or has participated in a study with an investigational compound or device within 45 days of signing informed consent
Patient is pregnant or breastfeeding, or expecting to conceive