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 |
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.
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
1707 North Mills Avenue
Orlando, Florida 32803
Orlando, Florida 32803
Phone: 407-647-3960
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4728 West Alabama Street
Houston, Texas 77098
Houston, Texas 77098
Phone: 713-526-0005
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1 Shields Ave
Sacramento, California 95616
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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