Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 7:50 PM
Ignite Modification Date:
2025-12-24 @ 7:50 PM
NCT ID:
NCT02217904
Eligibility Criteria:
Inclusion Criteria:
* 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 Criteria:
* 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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
60 Years
Study:
NCT02217904
Study Brief:
Protocol Section:
NCT02217904