Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Gilead Sciences
With
Merck Sharp & Dohme LLC
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Received bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF) for ≥ 24 weeks at screening.
Documented plasma human immunodeficiency virus type 1 (HIV-1) ribonucleic acid (RNA) \< 50 copies/mL (or undetectable HIV-1 RNA level according to the local assay being used if the limit of detection is ≥ 50 copies/mL) for ≥ 24 weeks before and at screening.
Plasma HIV-1 RNA \< 50 copies/mL at screening.
You may not be if
History of prior virologic failure while receiving treatment for HIV-1.
Prior use of, or exposure to, islatravir (ISL) or lenacapavir (LEN).
Active, serious infections requiring parenteral therapy \< 30 days before randomization.
Active or occult hepatitis B virus (HBV) coinfection, defined as hepatitis B core antibody (HBcAb) positive, hepatitis B surface antigen (HBsAg) positive, or HBV deoxyribonucleic acid (DNA) positive as determined by the central laboratory.
Active hepatitis C virus (HCV) coinfection, defined as detectable HCV RNA.
Any of the following laboratory values at screening:
* Creatinine clearance (CLcr) ≤ 30 mL/min according to the Cockcroft-Gault formula
Individuals of childbearing potential (as defined in protocol) who have a positive serum pregnancy test at screening or positive urine and serum pregnancy tests at Day 1 prior to study drug administration.
Individuals who plan to continue breastfeeding during the study.
Documented historical or screening resistance reports showing nucleoside/nucleotide reverse transcriptase inhibitors (NRTIs) or non-nucleoside/nucleotide reverse transcriptase inhibitors (NNRTIs) resistance mutations in reverse transcriptase, including M184V/I (Cohort 2).
Clareo Health | Study Evaluating the Safety and Efficacy of Islatravir in Combination With Lenacapavir in Virologically Suppressed People With HIV
