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Purpose

Researchers are looking for new treatments for people living with HIV-1(Human Immunodeficiency Virus Type 1). HIV-1 is the most common type of HIV, which is a virus that attacks cells of the immune system. HIV-1 treatments, called ART (antiretroviral therapy), involve taking medicines to lower the amount of HIV-1 virus in the body. Standard ART may include Bictegravir/Emtricitabine/Tenofovir Alafenamide (BIC/FTC/TAF) and Dolutegravir (DTG). MK-4646 is a trial medicine designed to treat HIV-1. Before giving a trial medicine to people with a health condition, researchers first do trials in healthy people. The goals of this study are to learn: - If taking MK 4646 together with BIC/FTC/TAF or DTG changes the amount of these ARTs in the blood over time. - About the safety of MK-4646 and if people tolerate it. Tolerate means participants will receive treatment in the trial unless they need to stop it due to health problems.

Condition

Eligibility

Eligible Ages
Between 18 Years and 60 Years
Eligible Sex
All
Accepts Healthy Volunteers
Yes

Inclusion Criteria

  • Is in good health before randomization - Has a body mass index (BMI) between 18 and 32 kg/m^2, inclusive

Exclusion Criteria

  • Has a history of clinically significant endocrine, gastrointestinal (GI), cardiovascular, hematological, hepatic, immunological, renal, respiratory, genitourinary, or major neurological (including stroke and chronic seizures) abnormalities or diseases - Has a history of cancer (malignancy)

Study Design

Phase
Phase 1
Study Type
Interventional
Allocation
Randomized
Intervention Model
Crossover Assignment
Primary Purpose
Basic Science
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Treatment A: bictegravir/emtricitabine/tenofovir alafenamide (BIC/FTC/TAF) 		Participants will receive a single oral dose of bictegravir/emtricitabine/tenofovir alafenamide (BIC/FTC/TAF).
  • Drug: Bictegravir/emtricitabine/tenofovir alafenamide
    Single oral tablet
Experimental
Treatment B: dolutegravir (DTG) 		Participants will receive a single oral dose of dolutegravir (DTG).
  • Drug: Dolutegravir
    Oral tablet
Experimental
Treatment C: MK-4646 + bictegravir/ emtricitabine/tenofovir alafenamide (BIC/FTC/TAF) 		Participants will receive a single oral dose of MK-4646 coadministered with bictegravir/emtricitabine/tenofovir alafenamide (BIC/FTC/TAF).
  • Drug: Bictegravir/emtricitabine/tenofovir alafenamide
    Single oral tablet
  • Drug: MK4646
    Oral capsule
Experimental
Treatment D: MK-4646 + dolutegravir (DTG) 		Participants will receive a single oral dose of MK-4646 coadministered with dolutegravir (DTG).
  • Drug: Dolutegravir
    Oral tablet
  • Drug: MK4646
    Oral capsule

Recruiting Locations

Pinnacle Research Group ( Site 0001)
Anniston, Alabama 36207
Contact:
Study Coordinator
256-236-0055

More Details

Status
Recruiting
Sponsor
Merck Sharp & Dohme LLC

Study Contact

Toll Free Number
1-888-577-8839
Trialsites@msd.com

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.