HIV-1 InfectionPhase 1NCT01353898

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

A Phase 1 study testing MK-1972 in people with HIV-1 Infection, run by Merck Sharp & Dohme LLC.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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Trial summary

Who is it for?: Ages 18 to 55 years, men only
Conditions the study is for: HIV-1 Infection
What is being tested?: MK-1972
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 12 participants
Where: No sites listed yet
Study dates: 21 Jun 2011to 3 Jan 2012
Phase: Phase 1
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 55 years
Men only
No healthy volunteers
Adult

Who may be able to join

Stable baseline health.
Appropriate use of contraception; condom protection with pregnant partners.
Documented HIV-1 positive
Anti-retroviral therapy (ART)-naïve, defined as having never received any antiretroviral agent or ≤30 consecutive days of an investigational antiretroviral agent, excluding an integrase inhibitor, or ≤60 consecutive days of combination ART excluding an integrase inhibitor.
No investigational agent or licensed ART within 30 days of study drug administration.
Diagnosis of HIV-1-infection ≥ 3 months prior to screening.

Who cannot join

History of stroke, chronic seizures, or major neurological disorder.
History of clinically significant endocrine, gastrointestinal, cardiovascular, hematological, hepatic, immunological (outside of HIV-1 infection), renal, respiratory, or genitourinary abnormalities or diseases.
History of clinically significant neoplastic disease.
Use of any immune therapy agents or immunosuppressive therapy within 1 month prior to treatment in this study.
Requirement for chronic daily prescription medications.
Current (active) diagnosis of acute hepatitis due to any cause.

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History of chronic Hepatitis C unless there has been documented cure and/or participant with a positive serologic test for Hepatitis C virus (HCV) has a negative HCV viral load.
Positive Hepatitis B surface antigen.
Refusal to stop using any medication, including prescription and non-prescription drugs or herbal remedies (such as St. John's Wort [Hypericum perforatum]) beginning approximately 2 weeks (or 5 half-lives) prior to administration of the initial dose of study drug, throughout the study (including washout intervals), until the post-study visit.
Consumption of excessive amounts of alcohol, defined as greater than 3 glasses of alcoholic beverages (1 glass is approximately equivalent to: beer [284 mL/10 ounces], wine [125 mL/4 ounces], or distilled spirits [25 mL/1 ounce]) per day.
Consumption of excessive amounts, defined as greater than 6 servings (1 serving is approximately equivalent to 120 mg of caffeine) of coffee, tea, cola, or other caffeinated beverages per day.
Smoker of more than 10 cigarettes/day unwilling to restrict smoking to ≤10 cigarettes per day.
Major surgery, donation or loss of 1 unit of blood (approximately 500 mL) or participation in another investigational study within 4 weeks prior to screening.
History of significant multiple and/or severe allergies (including latex allergy), or an anaphylactic reaction or significant intolerability to prescription or non-prescription drugs or food.
Current regular user of any illicit drugs or has a history of drug (including alcohol) abuse within approximately 1 year. Participants with a positive cannabis test with no evidence of drug-dependency may be enrolled at the discretion of the investigator.
History of hepatic or gallbladder disease or history of clinically significant abnormalities in liver function tests, or history of Gilbert's Syndrome, or history of elevated unconjugated bilirubin.

About this study

Official title: A Multiple Dose Clinical Trial to Study the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of MK-1972 in HIV-1 Infected Patients

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.

Conditions: HIV-1 Infection
Being tested: MK-1972, Placebo to MK-1972

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

MK-1972Drug
MK-1972 will be supplied as 25 and 100 mg capsules, and will be given orally, at a dose dependent on the treatment arm; participants will take ten capsules (active drug and/or placebo) once or twice per day for 10 days
Placebo to MK-1972Drug
Placebo will be supplied as matching 25 and 100 mg capsules, and will be given orally, at a dose dependent on the treatment arm; participants will take ten capsules (active drug and/or placebo) once or twice per day for 10 days

Study groups in NCT01353898
Study group	Role	What they receive
MK-1972 50 mg once daily (Part I)	Experimental	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) Receives: Drug: MK-1972; Drug: Placebo to MK-1972
MK-1972 200 mg once daily (Part I)	Experimental	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) Receives: Drug: MK-1972; Drug: Placebo to MK-1972
MK-1972 800 mg once daily (Part I)	Experimental	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) Receives: Drug: MK-1972; Drug: Placebo to MK-1972
MK-1972 25 mg twice daily (Part I)	Experimental	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) Receives: Drug: MK-1972; Drug: Placebo to MK-1972
MK-1972 100 mg twice daily (Part I)	Experimental	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) Receives: Drug: MK-1972; Drug: Placebo to MK-1972
Placebo twice daily (Part I)	Placebo comparator	Ten capsules containing placebo were taken orally, twice per day for 10 days (Part I) Receives: Drug: Placebo to MK-1972
MK-1972 800 mg twice daily (Part II)	Experimental	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) Receives: Drug: MK-1972; Drug: Placebo to MK-1972
Placebo twice daily (Part II)	Placebo comparator	Ten capsules containing placebo were taken orally, twice per day for 10 days (Part II) Receives: Drug: Placebo to MK-1972

What is being measured

The primary outcome is the main question the study is designed to answer.

Number of Participants Experiencing Clinical and Laboratory Adverse Events (AEs)
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.
Measured: From consent to 14 days after the last dose (up to Day 24)
Change From Baseline to Day 10 in Plasma Human Immunodeficiency Virus (HIV)-1 Ribonucleic Acid (RNA) Due to Treatment With MK-1972 or Placebo
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.
Measured: Baseline and Day 10 (24 hours post-dose)

Secondary outcomes (1)

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
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.
Measured: 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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

21 Jun 20113 Jan 2012

First posted16 May 2011 (estimated)
Study start21 Jun 2011
Primary completion3 Jan 2012
Study completion3 Jan 2012

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for HIV-1 InfectionStudies of the same condition, open and under way.
More trials run by Merck Sharp & Dohme LLCThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 12 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01353898
Sponsor's protocol ID: 1972-003
Other IDs: 2011-000071-14
Status last verified: Jul 2018
First submitted: 12 May 2011
Last updated: 29 Aug 2018
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
Individual data sharing: Yes: https://www.merck.com/clinical-trials/pdf/ProcedureAccessClinicalTrialData.pdf

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

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Study at a glance

From the registry record, last updated by the sponsor on 29 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Multiple Dose Clinical Trial to Study the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of MK-1972 in HIV-1 Infected Patients
ClinicalTrials.gov ID: NCT01353898
Acronym / sponsor ID: 1972-003
Conditions: HIV-1 Infection
Phase: Phase 1
Study type: Interventional
Recruitment status: Terminated
Enrolment: 12 participants (actual)
Lead sponsor: Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
Study start: 21 Jun 2011 (actual)
Primary completion: 3 Jan 2012 (actual)
Study completion: 3 Jan 2012 (actual)
First posted: 16 May 2011 (estimated)
Results: Posted 5 Feb 2016

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 8

Arm	Type	Receives
MK-1972 50 mg once daily (Part I)	Experimental	Drug: MK-1972, Drug: Placebo to MK-1972Ten 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)	Experimental	Drug: MK-1972, Drug: Placebo to MK-1972Ten 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)	Experimental	Drug: MK-1972, Drug: Placebo to MK-1972Ten 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)	Experimental	Drug: MK-1972, Drug: Placebo to MK-1972Ten 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)	Experimental	Drug: MK-1972, Drug: Placebo to MK-1972Ten 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 comparator	Drug: Placebo to MK-1972Ten capsules containing placebo were taken orally, twice per day for 10 days (Part I)
MK-1972 800 mg twice daily (Part II)	Experimental	Drug: MK-1972, Drug: Placebo to MK-1972Ten 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 comparator	Drug: Placebo to MK-1972Ten capsules containing placebo were taken orally, twice per day for 10 days (Part II)

Who may qualify

Ages: 18 to 55 years
Sex: Male only
Healthy volunteers: Not accepted
Age groups: Adult

Key inclusion criteria (6 listed)

Stable baseline health.
Appropriate use of contraception; condom protection with pregnant partners.
Documented HIV-1 positive
Anti-retroviral therapy (ART)-naïve, defined as having never received any antiretroviral agent or ≤30 consecutive days of an investigational antiretroviral agent, excluding an integrase inhibitor, or ≤60 consecutive days of combination ART excluding an integrase inhibitor.
No investigational agent or licensed ART within 30 days of study drug administration.

Key exclusion criteria (16 listed)

History of stroke, chronic seizures, or major neurological disorder.
History of clinically significant endocrine, gastrointestinal, cardiovascular, hematological, hepatic, immunological (outside of HIV-1 infection), renal, respiratory, or genitourinary abnormalities or diseases.
History of clinically significant neoplastic disease.
Use of any immune therapy agents or immunosuppressive therapy within 1 month prior to treatment in this study.
Requirement for chronic daily prescription medications.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
MK-1972MK-1972 will be supplied as 25 and 100 mg capsules, and will be given orally, at a dose dependent on the treatment arm; participants will take ten capsules (active drug and/or placebo) once or twice per day for 10 days	Drug	MK-1972 100 mg twice daily (Part I), MK-1972 200 mg once daily (Part I), MK-1972 25 mg twice daily (Part I), MK-1972 50 mg once daily (Part I), MK-1972 800 mg once daily (Part I), MK-1972 800 mg twice daily (Part II)
Placebo to MK-1972Placebo will be supplied as matching 25 and 100 mg capsules, and will be given orally, at a dose dependent on the treatment arm; participants will take ten capsules (active drug and/or placebo) once or twice per day for 10 days	Drug	MK-1972 100 mg twice daily (Part I), MK-1972 200 mg once daily (Part I), MK-1972 25 mg twice daily (Part I), MK-1972 50 mg once daily (Part I), MK-1972 800 mg once daily (Part I), MK-1972 800 mg twice daily (Part II), Placebo twice daily (Part I), Placebo twice daily (Part II)

Primary outcome

Number of Participants Experiencing Clinical and Laboratory Adverse Events (AEs)
Time frame: 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
Time frame: 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.

1 secondary outcome

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
Time frame: 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

Results and safety

Results posted to the registry on 5 Feb 2016, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
MK-1972 50 mg Once Daily (Part I)	2	2
MK-1972 200 mg Once Daily (Part I)	2	2
MK-1972 800 mg Once Daily (Part I)	2	2
MK-1972 25 mg Twice Daily (Part I)	2	2
MK-1972 100 mg Twice Daily (Part I)	2	2
Placebo Twice Daily (Part I)	2	1

Primary outcome: Number of Participants Experiencing Clinical and Laboratory Adverse Events (AEs)

Time frame: From consent to 14 days after the last dose (up to Day 24). Number. Unit: Participants

Measure	MK-1972 50 mg Once Daily (Part I) n = 2	MK-1972 200 mg Once Daily (Part I) n = 2	MK-1972 800 mg Once Daily (Part I) n = 2	MK-1972 25 mg Twice Daily (Part I) n = 2	MK-1972 100 mg Twice Daily (Part I) n = 2	Placebo Twice Daily (Part I) n = 2
Value	2	1	2	2	1	2

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

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

Time frame: Baseline and Day 10 (24 hours post-dose). Mean (Standard Error). Unit: log10 copies/mL

Measure	MK-1972 50 mg Once Daily (Part I) n = 2	MK-1972 200 mg Once Daily (Part I) n = 2	MK-1972 800 mg Once Daily (Part I) n = 2	MK-1972 25 mg Twice Daily (Part I) n = 2	MK-1972 100 mg Twice Daily (Part I) n = 2	Placebo Twice Daily (Part I) n = 2
Value	-0.97 (0.20)	-0.60 (0.30)	-1.06 (0.60)	-0.60 (0.42)	-1.90 (0.33)	-0.07 (0.05)

MK-1972 50 mg Once Daily (Part I) vs Placebo Twice Daily (Part I): Mean Difference (Final Values): -0.90
MK-1972 200 mg Once Daily (Part I) vs Placebo Twice Daily (Part I): Mean Difference (Final Values): -0.54
MK-1972 800 mg Once Daily (Part I) vs Placebo Twice Daily (Part I): Mean Difference (Final Values): -0.99

Population analysed: 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.

1 secondary outcome is reported in the full results.

Adverse events

Time frame: Up to Day 24. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
MK-1972 50 mg Once Daily (Part I)	0 of 2 (0%)	2 of 2 (100%)	Not reported
MK-1972 200 mg Once Daily (Part I)	0 of 2 (0%)	1 of 2 (50%)	Not reported
MK-1972 800 mg Once Daily (Part I)	0 of 2 (0%)	2 of 2 (100%)	Not reported
MK-1972 25 mg Twice Daily (Part I)	0 of 2 (0%)	2 of 2 (100%)	Not reported
MK-1972 100 mg Twice Daily (Part I)	0 of 2 (0%)	1 of 2 (50%)	Not reported
Placebo Twice Daily (Part I)	0 of 2 (0%)	1 of 2 (50%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 29 Aug 2018.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: Yes. https://www.merck.com/clinical-trials/pdf/ProcedureAccessClinicalTrialData.pdf

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Medical Director study director

Merck Sharp & Dohme LLC

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing MK-1972 in people with HIV-1 Infection, run by Merck Sharp & Dohme LLC.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 29 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 5 Feb 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants Experiencing Clinical and Laboratory Adverse Events (AEs) (time frame: From consent to 14 days after the last dose (up to Day 24)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01353898.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Aug 2018.