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HIV-1 InfectionPhase 1NCT02174159

Evaluation of Safety, Tolerability, Pharmacokinetics, and Antiretroviral Activity of Ulonivirine (MK-8507) in Human Immunodeficiency Virus (HIV-1)-Infected Participants (MK-8507-003)

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

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The study will evaluate the safety, tolerability, pharmacokinetics, and antiretroviral activity of a single dose of ulonivirine in antiretroviral therapy (ART)-naive, HIV-1 infected participants. Read more about this study

Who is it for?
Ages 18 to 60 years
Conditions the study is for
HIV-1 Infection
What is being tested?
Ulonivirine
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
18 participants
Where
No sites listed yet
Study dates
15 Sep 2014to 23 Jul 2015
Phase
Phase 1
Are there results?
None posted in the registry

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 60 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • Male, or non-pregnant and non-breastfeeding female, or postmenopausal or surgically sterile female (confirmed with medical records, examination, or laboratory test). Male participants with female partner of childbearing potential agrees to use a medically acceptable method of contraception during the study and 90 days after receiving study drug.
  • Body mass index <=35 kg/m^2
  • Other than HIV infection, baseline health judged to be stable at screening and/or prior to administration of study drug
  • No clinically-significant electrocardiogram abnormality
  • Documented to be HIV-1 positive as determined by a positive enzyme-linked immunosorbent assay (ELISA) or quantitative polymerase chain reaction (PCR) result with confirmation
  • Has a screening plasma Cluster of Differentiation (CD4) T-cell count of >200 /mm^3
Show all 12Show fewer
  • Has a plasma HIV-1 RNA >= 10,000 copies/mL within 30 days before administration of study drug
  • ART-naive, defined as never having received any ART agent, or have received <=30 consecutive days of an investigational ART agent, excluding non-nucleoside reverse transcriptase inhibitors (NNRTIs), or have received <=60 consecutive days of combination ART, excluding NNRTIs
  • Has not received an investigational agent or licensed ART within 30 days of study drug administration
  • Diagnosed with HIV-1 infection >=3 months before screening
  • Willing to receive no other ART for the duration of the study
  • Has no evidence of mutations conferring resistance to NNRTIs at screening

Who cannot join

  • Mentally or legally institutionalized or incapacitated, has significant emotional problems, or has a history of clinically significant psychiatric disorder
  • History of clinically significant and not stably controlled abnormalities or diseases
  • History of cancer, with the exceptions of 1) adequately-treated non-melanomatous skin carcinoma or carcinoma in situ of the cervix, 2) other malignancies which have been successfully treated >=10 years before screening, or 3) participants who are highly unlikely to sustain a recurrence for the duration of the study
  • History of significant multiple and/or severe allergies, or has had an anaphylactic reaction or significant intolerability to drugs or food
  • Positive for hepatitis B surface antigen
  • History of chronic hepatitis C virus (HCV) unless there has been a documented cure or a negative HCV viral load
Show all 13Show fewer
  • Had major surgery, or donated or lost >=1 unit (~500 mL) of blood within 4 weeks before screening
  • Participated in another investigational trial within 4 weeks before administration of study drug
  • Unable to refrain from or anticipates the use of any medication beginning 4 weeks before administration of study drug and throughout the trial. Certain medications are permitted.
  • Consumes >3 glasses of alcoholic beverages per day (1 glass is equivalent to 12 ounces of beer, 4 ounces of wine, or 1 ounce of distilled spirits). Participants who consume 4 glasses of alcoholic beverages per day may be enrolled at the discretion of the investigator.
  • Consumes >10 cigarettes per day and is unwilling to restrict smoking to <=10 cigarettes per day
  • Regular user of any illicit drugs or has a history of drug abuse (including alcohol) within 2 years
  • Has an immediate family member who is investigational site or sponsor staff directly involved with the trial

About this study

Official title: A Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Antiretroviral Activity of MK-8507 in HIV-1 Infected Patients

The study will evaluate the safety, tolerability, pharmacokinetics, and antiretroviral activity of a single dose of ulonivirine in antiretroviral therapy (ART)-naive, HIV-1 infected participants. The hypothesis tested in the study is that at a safe and well-tolerated dose, ulonivirine has superior antiretroviral activity to a historical placebo control, as measured by change from baseline in plasma HIV-1 ribonucleic acid (RNA) at 168 hours postdose.

Conditions
HIV-1 Infection
Being tested
Ulonivirine

What participants receive

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

  • UlonivirineDrug

    Also called MK-8507

    MK-8507 administered as a single oral dose

Study groups in NCT02174159
Study groupRoleWhat they receive
Panel A: Ulonivirine 600 mgExperimentalSingle oral dose of ulonivirine 600 mg (supplied as 10 mg and 100 mg tablets) administered after an overnight fast
Receives: Drug: Ulonivirine
Panel B: Ulonivirine 150 mgExperimentalSingle oral dose of ulonivirine 150 mg (supplied as 10 mg and 100 mg tablets) administered after an overnight fast
Receives: Drug: Ulonivirine
Panel C: Ulonivirine <=600 mgExperimentalSingle oral dose of ulonivirine <=600 mg mg (supplied as 10 mg and 100 mg tablets) administered after an overnight fast. Inclusion of Panel C in the study, and the dose selected, will be decided pending evaluation of results for Panels A and B.
Receives: Drug: Ulonivirine

What is being measured

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

  1. Change from Baseline in Plasma HIV-1 RNA

    Measured: 168 hours (7 days) postdose

  2. Number of Participants with One or More Adverse Experiences

    Measured: Up to 21 days postdose

Secondary outcomes (6)

  1. Area Under the Plasma Concentration-Time Curve of Ulonivirine (AUC0-168hr)

    Measured: Up to 168 hours postdose

  2. Maximum Plasma Concentration of Ulonivirine (Cmax)

    Measured: Up to 336 hours postdose

  3. Time of Maximum Plasma Concentration of Ulonivirine (Tmax)

    Measured: Up to 336 hours postdose

  4. Plasma Concentration of Ulonivirine at 168 Hours Postdose (C168hr)

    Measured: 168 hours postdose

  5. Plasma Concentration of Ulonivirine at 336 Hours Postdose (C336hr)

    Measured: 336 hours postdose

  6. Apparent Terminal Half-Life (T1/2) of Plasma Ulonivirine

    Measured: Up to 336 hours postdose

Timeline

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

  1. First posted25 Jun 2014 (estimated)
  2. Study start15 Sep 2014
  3. Primary completion16 Jul 2015
  4. Study completion23 Jul 2015

Resources

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
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
18 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02174159
Sponsor's protocol ID
8507-003
Other IDs
2014-000660-18, 2014
Status last verified
Apr 2023
First submitted
24 Jun 2014
Last updated
10 Apr 2023
Results posted
No
Data monitoring committee
No
Individual data sharing
Yes: http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf

Publications

  • Schurmann D, Jackson Rudd D, Schaeffer A, De Lepeleire I, Friedman EJ, Robberechts M, Zhang S, Liu Y, Kandala B, Keicher C, Daumer M, Hofmann J, Grobler JA, Stoch SA, Iwamoto M, Ankrom W. Single Oral Doses of MK-8507, a Novel Non-Nucleoside Reverse Transcriptase Inhibitor, Suppress HIV-1 RNA for a Week. J Acquir Immune Defic Syndr. 2022 Feb 1;89(2):191-198. doi: 10.1097/QAI.0000000000002834.

    PubMed 34654041

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Ulonivirine 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 12 inclusion and 13 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: finished, as of the sponsor's last update on 10 Apr 2023. 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. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Change from Baseline in Plasma HIV-1 RNA (time frame: 168 hours (7 days) postdose). 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 NCT02174159, which also lists 1 linked publication.

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 10 Apr 2023.

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