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Not yet recruiting NCT07600775

A Clinical Trial of MK-8527 and Rifampin in Adult Participants With Latent Tuberculosis Infection (MK-8527-019)

Phase I Interventional Human Immunodeficiency Virus (HIV) HIV Pre-Exposure Prophylaxis

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: MK-8527, Rifampin.
Who it may be relevant to
Registry conditions: Human Immunodeficiency Virus (HIV), HIV Pre-Exposure Prophylaxis. Basic parameters: 18 years — 60 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

An Open-label, Phase 1 Study to Characterize the Effects of Rifampin on the Pharmacokinetics of MK-8527 in Adult Participants With Latent Tuberculosis Infection

Overview

Researchers are studying MK-8527, a new medicine for preventing HIV-1 (human immunodeficiency virus type 1) infection and want to learn if MK-8527 can be given together with rifampin. Rifampin is commonly used to treat people with latent tuberculosis infection (LTBI). The main goal of this study is to learn what happens to MK-8527 in the body over time when given with and without the medication rifampin in participants with LTBI.

Interventions

  • Drug MK-8527
    Administered orally
  • Drug Rifampin
    Administered orally

Primary outcome measures

  • Area Under the Concentration-Time Curve From Time Zero to Infinity (AUC0-inf) of MK-8527 [Time frame: At designated time points (up to approximately 2 weeks)]
Secondary outcome measures (9)
  • Area Under the Concentration-Time Curve From Time Zero to Last Quantifiable Concentration (AUC0-last) of MK-8527 [Time frame: At designated time points (up to approximately 2 weeks)]
  • Area Under the Concentration-Time Curve From Time Zero to 336 Hours (AUC0-336) of MK-8527 [Time frame: At designated time points (up to approximately 2 weeks)]
  • Maximum Plasma Concentration (Cmax) of MK-8527 [Time frame: At designated time points (up to approximately 2 weeks)]
  • Time to Maximum Plasma Concentration (Tmax) of MK-8527 [Time frame: At designated time points (up to approximately 2 weeks)]
  • Terminal Elimination Half-Life (T1/2) of MK-8527 [Time frame: At designated time points (up to approximately 2 weeks)]
  • Apparent Clearance (CL/F) of MK-8527 [Time frame: At designated time points (up to approximately 2 weeks)]
  • Apparent Volume of Distribution During Terminal Phase (Vz/F) of MK-8527 [Time frame: At designated time points (up to approximately 2 weeks)]
  • Number of Participants Who Experience an Adverse Event (AE) [Time frame: Up to approximately 8 weeks]
  • Number of Participants Who Discontinue Study Treatment Due to an AE [Time frame: Up to approximately 8 weeks]

Eligibility criteria

Inclusion criteria

The main inclusion criteria include but are not limited to the following:

  • Has a diagnosis of untreated latent tuberculosis infection (LTBI)
  • Has no symptoms of active tuberculosis (TB)
  • Has never received treatment for TB or LTBI
  • Other than having LTBI, is in good health

Exclusion criteria

The main exclusion criteria include but are not limited to the following:

  • Has a diagnosis of LTBI made in the context of an outbreak/contact-tracing investigation
  • Has a current or anticipated immunocompromised state
  • Has a history of clinically significant endocrine, gastrointestinal, cardiovascular, hematological, hepatic, immunological, renal, respiratory, genitourinary, or major neurological abnormalities or diseases
  • Has a history of cancer (malignancy)
  • Has a history of active TB
  • Has positive test results for hepatitis B surface antigen, hepatitis C antibodies, or human immunodeficiency virus

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07600775 · 8527-019 · MK-8527-019

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗