NCT01353898

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

Terminated Phase 1 Results posted Last updated 29 August 2018

What this trial tests

Phase 1 trial testing MK-1972 in HIV-1 Infection in 12 participants. Terminated before completion.

Timeline

21 June 2011

Primary endpoint
3 January 2012

3 January 2012

Quick facts

Lead sponsor	Merck Sharp & Dohme LLC
Phase	Phase 1
Status	Terminated
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	treatment
Enrollment	12
Start date	21 June 2011
Primary completion	3 January 2012
Estimated completion	3 January 2012

Drugs / interventions tested

• MK-1972 — full drug profile →
• Placebo to MK-1972 — full drug profile →

Conditions studied

• HIV-1 Infection — all drugs for HIV-1 Infection →

Sponsor

Merck Sharp & Dohme LLC — full company profile →

Who can join

Adults 18 to 55, male only, with HIV-1 Infection. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Number of Participants Experiencing Clinical and Laboratory Adverse Events (AEs) Primary · 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.

Group	Value	95% CI
MK-1972 50 mg Once Daily (Part I)	2
MK-1972 200 mg Once Daily (Part I)	1
MK-1972 800 mg Once Daily (Part I)	2
MK-1972 25 mg Twice Daily (Part I)	2
MK-1972 100 mg Twice Daily (Part I)	1
Placebo Twice Daily (Part I)	2

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 Secondary · 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.

Group	Value	95% CI
MK-1972 50 mg Once Daily (Part I)	1540	± 24.3
MK-1972 200 mg Once Daily (Part I)	3590	± 43.8
MK-1972 800 mg Once Daily (Part I)	12500	± 15.5
MK-1972 25 mg Twice Daily (Part I)	676	± 27.6
MK-1972 100 mg Twice Daily (Part I)	1800	± 114

Change From Baseline to Day 10 in Plasma Human Immunodeficiency Virus (HIV)-1 Ribonucleic Acid (RNA) Due to Treatment With MK-1972 or Placebo Primary · 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.

Group	Value	95% CI
MK-1972 50 mg Once Daily (Part I)	-0.97	± 0.20
MK-1972 200 mg Once Daily (Part I)	-0.60	± 0.30
MK-1972 800 mg Once Daily (Part I)	-1.06	± 0.60
MK-1972 25 mg Twice Daily (Part I)	-0.60	± 0.42
MK-1972 100 mg Twice Daily (Part I)	-1.90	± 0.33
Placebo Twice Daily (Part I)	-0.07	± 0.05

Adverse events — posted to ClinicalTrials.gov

Time frame: Up to Day 24. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

MK-1972 50 mg Once Daily (Part I)

Serious: 0/2 (0%)

Deaths: —

MK-1972 200 mg Once Daily (Part I)

Serious: 0/2 (0%)

Deaths: —

MK-1972 800 mg Once Daily (Part I)

Serious: 0/2 (0%)

Deaths: —

MK-1972 25 mg Twice Daily (Part I)

Serious: 0/2 (0%)

Deaths: —

MK-1972 100 mg Twice Daily (Part I)

Serious: 0/2 (0%)

Deaths: —

Placebo Twice Daily (Part I)

Serious: 0/2 (0%)

Deaths: —

Other adverse events (16 terms — click to expand)

Reaction	System	MK-1972 50 mg Once Daily (…	MK-1972 200 mg Once Daily …	MK-1972 800 mg Once Daily …	MK-1972 25 mg Twice Daily …	MK-1972 100 mg Twice Daily…	Placebo Twice Daily (Part I)
Headache	Nervous system disorders	—	—	—	—	—	—
Vertigo	Ear and labyrinth disorders	—	—	—	—	—	—
Ocular hyperaemia	Eye disorders	—	—	—	—	—	—
Diarrhoea	Gastrointestinal disorders	—	—	—	—	—	—
Flatulence	Gastrointestinal disorders	—	—	—	—	—	—
Vomiting	Gastrointestinal disorders	—	—	—	—	—	—
Fatigue	General disorders	—	—	—	—	—	—
Bronchitis	Infections and infestations	—	—	—	—	—	—
Nasopharyngitis	Infections and infestations	—	—	—	—	—	—
Oral herpes	Infections and infestations	—	—	—	—	—	—
Arthralgia	Musculoskeletal and connective tissue disorders	—	—	—	—	—	—
Muscle contractions involuntary	Nervous system disorders	—	—	—	—	—	—
Pollakiuria	Renal and urinary disorders	—	—	—	—	—	—
Polyuria	Renal and urinary disorders	—	—	—	—	—	—
Epistaxis	Respiratory, thoracic and mediastinal disorders	—	—	—	—	—	—
Haematoma	Vascular disorders	—	—	—	—	—	—

Data from ClinicalTrials.gov NCT01353898 adverse events section.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.