MK-8591 With Doravirine and Lamivudine in Participants Infected With Human Immunodeficiency Virus Type 1 (MK-8591-011)



Status:Active, not recruiting
Conditions:HIV / AIDS
Therapuetic Areas:Immunology / Infectious Diseases
Healthy:No
Age Range:18 - Any
Updated:4/28/2018
Start Date:November 27, 2017
End Date:September 29, 2020

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A Phase 2B, Randomized, Double-Blind, Active-Comparator-Controlled, Dose-Ranging Clinical Trial to Evaluate the Safety, Tolerability, Antiretroviral Activity, and Pharmacokinetics of MK-8591 Given in Combination With Doravirine (DOR) and Lamivudine (3TC) in HIV-1-Infected Treatment-Naïve Adults

This study will evaluate the safety, tolerability, antiretroviral activity, and
pharmacokinetics of 3 doses of MK-8591 in combination with doravirine (DOR) and lamivudine
(3TC) administered to antiretroviral treatment-naïve adult participants with human
immunodeficiency virus type 1 (HIV-1) infection.


Inclusion Criteria:

- Has HIV-1 infection

- Is naïve to anti-retroviral therapy (ART).

- Is clinically stable, with no signs or symptoms of acute infection, at the time of
entry into the study

- Female is not pregnant, not breastfeeding, not a woman of childbearing potential
(WOCBP); but if WOCBP agrees to follow the contraceptive guidance

- All participants, male and female, agree to use barrier methods of contraception when
engaged in any sexual activity during treatment and for 6 weeks following treatment.

Exclusion Criteria:

- Is a user of recreational or illicit drugs or has had a history of drug or alcohol
abuse or dependence that may interfere with trial participation

- Has significant hypersensitivity or other contraindication to any of the components of
the study drugs

- Has a history of malignancy ≤5 years prior

- Female expects to donate eggs at any time during the study

- Is breastfeeding or expecting to conceive

- A WOCBP who has a positive urine pregnancy test on Day 1 before the first dose of
study treatment

- Has been treated for a viral infection other than HIV-1, such as hepatitis B, with an
agent that is active against HIV-1

- Has used systemic immunosuppressive therapy or immune modulators within 30 days prior
to treatment in this study or is anticipated to need them during the course of the
study

- Requires any of the following prohibited medications: Carbamazepine, Phenobarbital,
Phenytoin, Rifabutin, Rifampin, Herbal remedies, St. John's Wort, Modafinil, Bosentan,
Nafcillin, Pentostatin

- Is currently participating in or has participated in an interventional clinical trial
with an investigational compound or device within 30 days of signing informed consent
to participate in this current trial

- Has a documented or known virologic resistance to any approved HIV-1 reverse
transcriptase inhibitor, protease inhibitor, integrase inhibitor

- Has active hepatitis C virus (HCV) coinfection defined as detectable HCV RNA or HBV
co-infection defined as hepatitis B surface antigen [HBsAg]-positive

- Has a current (active) diagnosis of acute hepatitis due to any cause

- Has previously been randomized in a study and received MK-8591, DOR, MK-1439A, or 3TC.
We found this trial at
11
sites
Dallas, Texas 75246
Phone: 214-823-2533
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Bellaire, Texas 77401
Phone: 713-447-1822
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Chicago, Illinois 60657
Phone: 773-296-2400
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Chicago, IL
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Fort Worth, Texas 76104
Phone: 817-810-9810
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Fort Worth, TX
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4728 West Alabama Street
Houston, Texas 77098
Phone: 713-526-0005
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Houston, TX
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Kansas City, Missouri 64111
Phone: 816-777-2759
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Kansas City, MO
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1707 North Mills Avenue
Orlando, Florida 32803
Phone: 407-647-3960
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Orlando, FL
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Phoenix, Arizona 85015
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Phoenix, AZ
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1 Shields Ave
Sacramento, California 95616
(530) 752-1011
Phone: 916-734-0591
University of California-Davis As we begin our second century, UC Davis is poised to become...
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Sacramento, CA
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5413 Avenida Presidente Kennedy
Santiago, RM
Phone: +56992280653
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Santiago,
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Washington, District of Columbia
Phone: 202-745-6139
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Washington,
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