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) (onceMRK)

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Merck Sharp & Dohme Corp.

ClinicalTrials.gov Identifier:

NCT02131233

First received: May 2, 2014

Last updated: May 17, 2017

Last verified: May 2017

History of Changes

Results First Received: September 7, 2016

Study Type:	Interventional
Study Design:	Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Participant, Investigator, Outcomes Assessor; Primary Purpose: Treatment
Condition:	HIV Infection
Interventions:	Drug: Reformulated Raltegravir Drug: Raltegravir Drug: TRUVADA™ Drug: Placebo to Reformulated Raltegravir Drug: Placebo to Raltegravir

Participant Flow

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Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
These results stop at the primary data cutoff at Week 48

Reporting Groups

	Description
Reformulated Raltegravir	Reformulated raltegravir 1200 mg (2x 600 mg tablets) orally once daily plus placebo to raltegravir 1 tablet orally twice daily plus TRUVADA™ orally once daily for 96 weeks
Raltegravir	Raltegravir 400 mg tablet orally twice daily plus placebo to reformulated raltegravir 2 tablets orally once daily plus TRUVADA™ orally once daily for 96 weeks

Participant Flow: Overall Study

	Reformulated Raltegravir	Raltegravir
STARTED	533 ^[1]	269 ^[1]
Treated	531	266
COMPLETED	490 ^[2]	242 ^[2]
NOT COMPLETED	43	27
Not Treated	2	3
Adverse Event	6	6
Death	0	1
Lack of Efficacy	4	1
Lost to Follow-up	8	4
Non-Compliance With Study Drug	5	4
Physician Decision	4	0
Pregnancy	2	0
Withdrawal by Subject	12	8

^[1]	Enrolled participants
^[2]	Completed to Week 48

Baseline Characteristics

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Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
All Treated Participants

Reporting Groups

	Description
Reformulated Raltegravir	Reformulated raltegravir 1200 mg (2x 600 mg tablets) orally once daily plus placebo to raltegravir 1 tablet orally twice daily plus TRUVADA™ orally once daily for 96 weeks
Raltegravir	Raltegravir 400 mg tablet orally twice daily plus placebo to reformulated raltegravir 2 tablets orally once daily plus TRUVADA™ orally once daily for 96 weeks
Total	Total of all reporting groups

Baseline Measures

	Reformulated Raltegravir	Raltegravir	Total
Overall Participants Analyzed [Units: Participants]	531	266	797

Age [Units: Years] Mean (Standard Deviation)	35.4 (10.3)	36.9 (11.0)	35.9 (10.5)

Sex: Female, Male [Units: Participants] Count of Participants
Female	91 17.1%	32 12.0%	123 15.4%
Male	440 82.9%	234 88.0%	674 84.6%

Outcome Measures

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1. Primary:

Percentage of Participants Achieving <40 Copies/mL Human Immunodeficiency Virus-1 (HIV-1) Ribonucleic Acid (RNA) at Week 48 [ Time Frame: Week 48 ]

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2. Secondary:

Change From Baseline in Cluster of Differentiation 4 (CD4) Cell Count at Week 48 [ Time Frame: Baseline and Week 48 ]

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3. Secondary:

Percentage of Participants With an Adverse Event (AE) at Week 48 [ Time Frame: Up to Week 48 ]

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4. Secondary:

Percentage of Participants With a Drug-Related AE at Week 48 [ Time Frame: Up to Week 48 ]

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5. Secondary:

Percentage of Participants With a Serious Adverse Event (SAE) at Week 48 [ Time Frame: Up to Week 48 ]

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6. Secondary:

Percentage of Participants With a Serious and Drug-Related AE at Week 48 [ Time Frame: Up to Week 48 ]

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7. Secondary:

Percentage of Participants Who Discontinued From Drug Therapy Due to an AE at Week 48 [ Time Frame: Up to Week 48 ]

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8. Secondary:

Percentage of Participants Achieving <40 Copies/mL HIV-1 RNA at Week 96 [ Time Frame: Week 96 ]