A Study of Islatravir (ISL) and Ulonivirine (ULO) Once Weekly (QW) in Virologically Suppressed Adults With Human Immunodeficiency Virus Type 1 (HIV-1) (MK-8591B-060)
Condition(s) studied
Investigational drug(s) / intervention(s)
ISL: ISL 1mg oral capsule will be administered as 2mg orally (each capsule 1mg) as part of ISL and ULO combination to group 1 participants for 96 weeks and for group 2 participants in part 2 of the study from 49 to 96 weeks.
ULO: ULO 100mg oral tablet will be administered as 200mg (2 tablets) orally as part of ISL and ULO combination to group 1 participants for 96 weeks and for group 2 participants in part 2 of the study from 49 to 96 weeks.
BIC/FTC/TAF: BIC 50mg oral tablet/FTC 200mg oral tablet/TAF 25 mg oral tablet administered orally to group 2 participants for 48 weeks in part 1 of the study.
Study summary
Investigators are trying to find better treatments for people with HIV-1. In this clinical study, investigators want to see how well a new treatment called ISL+ULO, taken once a week, works compared to an existing treatment called BIC/FTC/TAF, which is taken every day. Investigators will check how many people still have a high level of the virus in their blood after 24 weeks. The investigators also want to understand if the new treatment, MK-8591B, is safe and how well people can handle it.
Eligibility
Primary outcome measure(s)
- Percentage of Participants With HIV-1 RNA ≥50 copies/mL at Week 24 — Week 24
Plasma HIV-1 ribonucleic acid (RNA) quantification will be performed at the central laboratory using a polymerase chain reaction (PCR) assay. Percentage of participants with HIV-1 RNA ≥50 copies/mL will be reported at week 24. - Percentage of Participants who Experience an Adverse Event (AE) — Up to ~ 96 weeks
An AE is any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. The percentage of participants who experience an AE will be reported. - Percentage of Participants Discontinuing Study Treatment due to AEs — Up to ~ 96 weeks
An AE is any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. The percentage of participants who discontinue study treatment due to an AE will be reported.
Trial sites (23)
| Facility | City | Region | Status |
|---|---|---|---|
| Zuckerberg San Francisco General Hospital and Trauma Center ( Site 4107) | San Francisco | California | |
| Mills Clinical Research ( Site 4109) | West Hollywood | California | |
| Georgetown University Medical Center ( Site 4106) | Washington D.C. | District of Columbia | |
| Orlando Immunology Center ( Site 4103) | Orlando | Florida | |
| Triple O Research Institute ( Site 4111) | West Palm Beach | Florida | |
| Chatham County Health Department - Chatham CARE Center ( Site 4116) | Savannah | Georgia | |
| KC CARE Health Center ( Site 4101) | Kansas City | Missouri | |
| Regional Center for Infectious Diseases ( Site 4115) | Greensboro | North Carolina | |
| Central Texas Clinical Research ( Site 4100) | Austin | Texas | |
| Prism Health North Texas, Oak Cliff Health Center ( Site 4114) | Dallas | Texas | |
| DCOL Center for Clinical Research ( Site 4112) | Longview | Texas | |
| Momentum Clinical Research - Darlinghurst ( Site 4260) | Darlinghurst | New South Wales | |
| St. Vincent's Hospital ( Site 4263) | Darlinghurst | New South Wales | |
| Momentum Clinical Research Fortitude Valley ( Site 4261) | Fortitude Valley | Queensland | |
| The Alfred Hospital ( Site 4264) | Melbourne | Victoria | |
| Prahran Market Clinic ( Site 4262) | Prahran | Victoria | |
| Ponce Medical School Foundation Inc./CAIMED Center ( Site 4301) | Ponce | Puerto Rico | |
| Clinical Research Puerto Rico ( Site 4300) | San Juan | Puerto Rico | |
| HOPE Clinical Research ( Site 4303) | San Juan | Puerto Rico | |
| University Hospital Basel-Infectiology ( Site 4402) | Basel | Canton of Basel-City | |
| Inselspital Bern-Inselspital Infektiologie ( Site 4403) | Bern | Canton of Bern | |
| Hôpitaux Universitaires de Genève (HUG)-Infectious Disease Department ( Site 4404) | Geneva | Canton of Geneva | |
| Ospedale Regionale di Lugano, Sede Civico-Servizio Malattie Infettive ( Site 4405) | Lugano | Canton Ticino |
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This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT06891066 on ClinicalTrials.gov ↗ ← All trials in the USA