Status:
COMPLETED
A Study of Islatravir (MK-8591) in Anti-Retroviral Therapy-Naive, Human Immunodeficiency Virus-1 Infected Participants (MK-8591-003)
Lead Sponsor:
Merck Sharp & Dohme LLC
Conditions:
HIV-1
Eligibility:
All Genders
18-60 years
Phase:
PHASE1
Brief Summary
This study will evaluate the safety, tolerability, pharmacokinetics, and anti-retroviral therapy (ART) activity of islatravir (MK-8591) monotherapy in ART-naive, human immunodeficiency virus-1 (HIV-1)...
Eligibility Criteria
Inclusion
- Non-pregnant, non-breast feeding, postmenopausal or surgically sterile female
- Female with reproductive potential agrees to use (or have male partner use) two acceptable methods of birth control
- Male agrees to use acceptable method of contraception during study and for 90 days after last dose of trial drug
- Has stable baseline health, other than HIV infection
- Has no significantly abnormal electrocardiogram
- Is HIV-1 positive
- Have a screening plasma HIV-1 RNA ≥ 10,000 copies/mL within 30 days prior to the treatment phase of this study. For inclusion in Panel Islatravir Extended Observation, participants must also have a screening plasma HIV-1 RNA ≤ 25,000 copies/mL within 30 days prior to the treatment phase.
- Is ART naive
- Has not received any investigational agent or marketed ART within 30 days of trial drug administration
- Is diagnosed with HIV-1 infection \>= 3 months prior to screening
- Is willing to receive no other ART during treatment phase of study
- Has no evidence of mutations conferring resistance to nucleoside reverse transcriptase inhibitors (NRTIs)
Exclusion
- Is mentally or legally institutionalized/incapacitated, or has significant emotional problems, or has a history of clinically significant psychiatric disorder of the last 5 years
- Has a history of clinically significant endocrine, gastrointestinal, cardiovascular, hematological, hepatic, immunological (outside of HIV-1 infection), renal, respiratory, genitourinary, major neurological abnormalities or diseases
- Has a history of cancer (malignancy)
- Has a history of significant multiple and/or severe allergies, or had an anaphylactic reaction to drugs or food
- Is positive for hepatitis B surface antigen
- Has a history of chronic Hepatitis C
- Had major surgery or lost 500 mL of blood with 4 weeks prior to screening visit
- Has participated in another investigational trial within 4 weeks prior to dosing visit
- Will use any medications, prescribed drugs, or herbal remedies 4 weeks prior to dosing of trial drug, up to the post-trial visit
- Consumes excessive amounts of alcohol, caffeinated beverages, or tobacco products
- Uses illicit drugs or has a history of drug abuse within the prior 2 years
Key Trial Info
Start Date :
September 17 2015
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 11 2017
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT02217904
Start Date
September 17 2015
End Date
May 11 2017
Last Update
August 12 2019
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