This is a randomized, controlled, double-blind, study to evaluate the safety and tolerability of islatravir (ISL) + ulonivirine based on review of the accumulated safety data, in adult participants with human immunodeficiency virus type 1 (HIV-1) who have been virologically suppressed for ≥6 months on bictegravir/emtricitabine/tenofovir alafenamide (BIC/FTC/TAF) once-daily.
Based on laboratory findings of decreased lymphocyte and CD4+ T-cell counts across the islatravir program and as described in protocol amendment 2 (approved 01-Dec-2021), participants in study Part 1 (double-blind treatment period) were unblinded, discontinued all study interventions, and switched to standard of care non-study antiretroviral (ART) therapy. Participants who received ISL + ulonivirine (Groups 1 to 3) may have then entered into an unblinded safety monitoring period and were monitored for ≥6 months. As specified in protocol amendment 2, study Parts 2 and 3 were no longer planned or initiated for any participant.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
161
ISL capsule taken by mouth.
Ulonivirine tablet taken by mouth.
BIC/FTC/TAF tablet taken by mouth.
Percentage of Participants Who Experienced One or More Adverse Events (AEs) During the Double-Blind Treatment Period +42 Days Post-Blind
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. As pre-specified in the protocol and supplemental statistical analysis plan (sSAP), presented here is the percentage of participants who experienced one or more AEs during the Double-blind Treatment Period and includes the 42 days following the final dose of double-blind study intervention.
Time frame: Up to approximately 9 months
Percentage of Participants Who Discontinued Study Intervention Due to an AE During the Double-Blind Treatment Period
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. As pre-specified in the protocol and sSAP, presented here is the percentage of participants who discontinued double-blind study intervention due to an AE during the Double-Blind Treatment Period.
Time frame: Up to approximately 8 months
Percentage of Participants Who Experienced One or More AEs During the Unblinded Safety Monitoring Period
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. As pre-specified in the protocol and sSAP, presented here is the percentage of participants who experienced one or more AEs during the Unblinded Safety Monitoring Period, beginning 42 days following the final dose of double-blind study intervention.
Time frame: Up to approximately 37 months
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Placebo capsule matched to ISL taken by mouth.
Placebo tablet matched to ulonivirine taken by mouth.
Placebo tablet matched to BIC/FTC/TAF taken by mouth.
Pueblo Family Physicians ( Site 2702)
Phoenix, Arizona, United States
Men's Health Foundation ( Site 2710)
Los Angeles, California, United States
Midway Immunology and Research ( Site 2713)
Ft. Pierce, Florida, United States
Triple O Research Institute, P.A. ( Site 2712)
West Palm Beach, Florida, United States
Infectious Disease Specialists Of Atlanta PC ( Site 2704)
Decatur, Georgia, United States
Chatham County Health Department ( Site 2707)
Savannah, Georgia, United States
Kansas City CARE Clinic ( Site 2703)
Kansas City, Missouri, United States
Saint Hope Foundation, Inc. ( Site 2716)
Bellaire, Texas, United States
Texas Centers for Infectious Disease Associates P.A. ( Site 2709)
Fort Worth, Texas, United States
DCOL Center for Clinical Research ( Site 2715)
Longview, Texas, United States
...and 13 more locations