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Evaluation of the Safety and Efficacy of Reformulated Raltegravir (MK-0518) 1200 mg Once Daily in Combination With TRUVADA™ in Human Immunodeficiency Virus (HIV)-1 Infected, Treatment-Naive Participants (MK-0518-292)

NCT02131233 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 802

Last updated 2019-01-30

Study results available
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Summary

To evaluate the safety and efficacy of reformulated raltegravir (MK-0518) 1200 mg once daily in combination with TRUVADA™ versus raltegravir 400 mg twice daily in combination with TRUVADA™ in HIV-1 infected, treatment-naive participants. The primary hypothesis being tested is that reformulated raltegravir 1200 mg once-daily is non-inferior to raltegravir 400 mg twice-daily, each in combination therapy with TRUVADA™, as assessed by the proportion of participants achieving HIV-1 ribonucleic acid (RNA) \<40 copies/mL at Week 48.

Conditions

  • HIV Infection

Interventions

DRUG

Reformulated Raltegravir

Reformulated raltegravir 1200 mg (2x 600 mg tablets) orally once daily

DRUG

Raltegravir

Raltegravir 400 mg tablet orally twice daily

DRUG

TRUVADA™

Emtricitabine / tenofovir disoproxil fumarate 200 / 300 mg tablet administered once-daily with food (open-label)

DRUG

Placebo to Reformulated Raltegravir

Placebo to reformulated raltegravir 2 tablets orally once daily

DRUG

Placebo to Raltegravir

Placebo to raltegravir 1 tablet orally twice daily

Sponsors & Collaborators

Principal Investigators

  • Medical Director · Merck Sharp & Dohme LLC

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-05-23
Primary Completion
2015-12-21
Completion
2016-12-19
FDA Drug
Yes

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Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02131233 on ClinicalTrials.gov