Study of MK-1972 in Human Immunodeficiency Virus (HIV)-1 Infected Participants Who Have Not Previously Received Antiretroviral Therapy (MK-1972-003)

Phase 1

Terminated

• Conditions: HIV-1 Infection
• Interventions: Drug: MK-1972; Drug: Placebo to MK-1972

• Registration Number: NCT01353898
• Lead Sponsor: Merck Sharp & Dohme LLC

Brief Summary

This is a two part study to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of MK-1972 in participants with HIV-1 infections. In Part 1, participants will be randomized to receive MK-1972 (at one of 5 different dose levels given once or twice per day) or placebo. Part II will begin after the results of Part I are known; participants will be randomized to receive MK-1972 (only one dose level, twice per day) or placebo. The primary hypotheses are that MK-1972 at the studied doses is safe and well tolerated in HIV-1 infected males; and that MK-1972 has superior antiretroviral activity compared to placebo.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2011-05-12
• Study First Submitted QC: 2011-05-12
• Study First Posted: 2011-05-16
• Study Start: 2011-06-21
• Primary Completion: 2012-01-03
• Study Completion: 2012-01-03
• Results First Submitted: 2016-01-06
• Results First Submitted QC: 2016-01-06
• Results First Posted: 2016-02-05
• Status Verified: 2018-07
• Last Update Submitted: 2018-07-31
• Last Update Posted: 2018-08-29

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Male
• Target Recruitment: 12

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
MK-1972 50 mg once daily (Part I)	MK-1972	Ten capsules containing a total daily dose of 50 mg MK-1972 or placebo were taken orally, once per day for 10 days (Part I)
MK-1972 50 mg once daily (Part I)	Placebo to MK-1972	Ten capsules containing a total daily dose of 50 mg MK-1972 or placebo were taken orally, once per day for 10 days (Part I)
MK-1972 200 mg once daily (Part I)	Placebo to MK-1972	Ten capsules containing a total daily dose of 200 mg MK-1972 or placebo were taken orally, once per day for 10 days (Part I)
MK-1972 800 mg once daily (Part I)	Placebo to MK-1972	Ten capsules containing a total daily dose of 800 mg MK-1972 or placebo were taken orally, once per day for 10 days (Part I)
MK-1972 25 mg twice daily (Part I)	Placebo to MK-1972	Ten capsules containing a total daily dose of 25 mg MK-1972 or placebo were taken orally, twice per day for 10 days (Part I)
MK-1972 100 mg twice daily (Part I)	Placebo to MK-1972	Ten capsules containing a total daily dose of 100 mg MK-1972 or placebo were taken orally, twice per day for 10 days (Part I)
Placebo twice daily (Part I)	Placebo to MK-1972	Ten capsules containing placebo were taken orally, twice per day for 10 days (Part I)
MK-1972 800 mg twice daily (Part II)	Placebo to MK-1972	Ten capsules containing a total daily dose of 800 mg MK-1972 or placebo were taken orally, twice per day for 10 days (Part II)
Placebo twice daily (Part II)	Placebo to MK-1972	Ten capsules containing placebo were taken orally, twice per day for 10 days (Part II)
MK-1972 200 mg once daily (Part I)	MK-1972	Ten capsules containing a total daily dose of 200 mg MK-1972 or placebo were taken orally, once per day for 10 days (Part I)
MK-1972 800 mg once daily (Part I)	MK-1972	Ten capsules containing a total daily dose of 800 mg MK-1972 or placebo were taken orally, once per day for 10 days (Part I)
MK-1972 25 mg twice daily (Part I)	MK-1972	Ten capsules containing a total daily dose of 25 mg MK-1972 or placebo were taken orally, twice per day for 10 days (Part I)
MK-1972 100 mg twice daily (Part I)	MK-1972	Ten capsules containing a total daily dose of 100 mg MK-1972 or placebo were taken orally, twice per day for 10 days (Part I)
MK-1972 800 mg twice daily (Part II)	MK-1972	Ten capsules containing a total daily dose of 800 mg MK-1972 or placebo were taken orally, twice per day for 10 days (Part II)

Primary Outcome Measures

Name	Time	Method
Number of Participants Experiencing Clinical and Laboratory Adverse Events (AEs)	From consent to 14 days after the last dose (up to Day 24)	An adverse event is any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the SPONSOR's product, whether or not considered related to the use of the product. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which is temporally associated with the use of the SPONSOR's product, is also an adverse event.
Change From Baseline to Day 10 in Plasma Human Immunodeficiency Virus (HIV)-1 Ribonucleic Acid (RNA) Due to Treatment With MK-1972 or Placebo	Baseline and Day 10 (24 hours post-dose)	Blood was collected at baseline and on Day 10, and the plasma concentration for HIV-1 RNA was determined using the Abbott RealTime HIV assay.

Secondary Outcome Measures

Name	Time	Method
The Area Under the Curve From 0-24 Hours (AUC0-24hrs) on Day 10 for Plasma Concentration of MK-1972 in Participants With HIV-1 Infection	Day 10: pre-dose, and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 16, and 24 hours post-dose	Plasma concentration of MK-1972 was determined from blood collected from HIV-1 infected participants on Day 10 : pre-dose up to 24 hours post-dose in order to determine the AUC0-24hrs.