Trial Outcomes & Findings for Study of MK-1972 in Human Immunodeficiency Virus (HIV)-1 Infected Participants Who Have Not Previously Received Antiretroviral Therapy (MK-1972-003) (NCT NCT01353898)

Last Updated: 2018-08-29

Results Overview

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.

Recruitment status

TERMINATED

Study phase

PHASE1

Target enrollment

12 participants

Primary outcome timeframe

From consent to 14 days after the last dose (up to Day 24)

Results posted on

2018-08-29

Participant Flow

Two treatment groups planned for Part II (800 mg MK-1972 twice daily, and Placebo twice daily) were not enrolled, and are therefore not included in these Results.

Participant milestones

Participant milestones
Measure	MK-1972 50 mg Once Daily (Part I) 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) 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) 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) 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) 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) Ten capsules containing placebo were taken orally, twice per day for 10 days (Part I)
Overall Study STARTED	2	2	2	2	2	2
Overall Study COMPLETED	2	2	2	2	2	1
Overall Study NOT COMPLETED	0	0	0	0	0	1

Reasons for withdrawal

Reasons for withdrawal
Measure	MK-1972 50 mg Once Daily (Part I) 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) 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) 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) 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) 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) Ten capsules containing placebo were taken orally, twice per day for 10 days (Part I)
Overall Study Study site terminated	0	0	0	0	0	1

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	MK-1972 50 mg Once Daily (Part I) n=2 Participants 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) n=2 Participants 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) n=2 Participants 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) n=2 Participants 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) n=2 Participants 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) n=2 Participants Ten capsules containing placebo were taken orally, twice per day for 10 days (Part I)	Total n=12 Participants Total of all reporting groups
Age, Continuous	31.5 Years STANDARD_DEVIATION 14.8 • n=5 Participants	24.0 Years STANDARD_DEVIATION 2.8 • n=7 Participants	32.5 Years STANDARD_DEVIATION 0.7 • n=5 Participants	47.5 Years STANDARD_DEVIATION 10.6 • n=4 Participants	37.0 Years STANDARD_DEVIATION 1.4 • n=21 Participants	37.0 Years STANDARD_DEVIATION 17.0 • n=8 Participants	34.9 Years STANDARD_DEVIATION 10.6 • n=8 Participants
Sex: Female, Male Female	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	0 Participants n=8 Participants
Sex: Female, Male Male	2 Participants n=5 Participants	2 Participants n=7 Participants	2 Participants n=5 Participants	2 Participants n=4 Participants	2 Participants n=21 Participants	2 Participants n=8 Participants	12 Participants n=8 Participants

PRIMARY outcome

Timeframe: From consent to 14 days after the last dose (up to Day 24)

Population: All participants who received at least one dose of the investigational drug, according to the treatment they actually received.

Outcome measures

Outcome measures
Measure	MK-1972 50 mg Once Daily (Part I) n=2 Participants 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) n=2 Participants 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) n=2 Participants 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) n=2 Participants 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) n=2 Participants 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) n=2 Participants Ten capsules containing placebo were taken orally, twice per day for 10 days (Part I)
Number of Participants Experiencing Clinical and Laboratory Adverse Events (AEs)	2 Participants	1 Participants	2 Participants	2 Participants	1 Participants	2 Participants

PRIMARY outcome

Timeframe: Baseline and Day 10 (24 hours post-dose)

Population: All participants who comply with the protocol sufficiently to ensure that these data will be likely to exhibit the effects of treatment, according to the underlying scientific model.

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.

Outcome measures

Outcome measures
Measure	MK-1972 50 mg Once Daily (Part I) n=2 Participants 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) n=2 Participants 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) n=2 Participants 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) n=2 Participants 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) n=2 Participants 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) n=2 Participants Ten capsules containing placebo were taken orally, twice per day for 10 days (Part I)
Change From Baseline to Day 10 in Plasma Human Immunodeficiency Virus (HIV)-1 Ribonucleic Acid (RNA) Due to Treatment With MK-1972 or Placebo	-0.97 log10 copies/mL Standard Error 0.20	-0.60 log10 copies/mL Standard Error 0.30	-1.06 log10 copies/mL Standard Error 0.60	-0.60 log10 copies/mL Standard Error 0.42	-1.90 log10 copies/mL Standard Error 0.33	-0.07 log10 copies/mL Standard Error 0.05

SECONDARY outcome

Timeframe: 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

Population: All participants who comply with the protocol sufficiently to ensure that these data will be likely to exhibit the effects of treatment, according to the underlying scientific model. MK-1972 was not measured for the placebo group since it did not receive any of this drug.

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.