Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Merck Sharp & Dohme LLC
Age
18–60
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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)
You may not be if
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
