The Crofoot Research Center, Inc. | Houston, TX
Status and phase
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About
The primary objective of this study is to evaluate the efficacy of oral weekly islatravir (ISL) in combination with lenacapavir (LEN) in virologically suppressed people with HIV (PWH) at Week 24.
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Inclusion and exclusion criteria
Key Inclusion Criteria:
Key Exclusion Criteria:
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:
CD4+ T-cells < 200 cells/mm^3 (Cohort 1); CD4+ T-cells < 350 cells/mm^3 (cohort 2).
Absolute lymphocyte count < 900 cells/mm^3 (cohort 2).
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).
Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Primary purpose
Allocation
Interventional model
Masking
142 participants in 2 patient groups
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Central trial contact
Gilead Clinical Study Information Center
Data sourced from clinicaltrials.gov
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