Dose Ranging, Switch Study of Islatravir (ISL) and Ulonivirine (MK-8507) Once-Weekly in Virologically-Suppressed Adults With Human Immunodeficiency Virus Type 1 (HIV-1) [MK-8591-013]

HIV-1 Infection Clinical Trial

Official title:

A Phase 2b, Randomized, Active-Controlled, Double-Blind, Dose-Ranging Clinical Study to Evaluate a Switch to Islatravir (ISL) and MK-8507 Once-Weekly in Adults With HIV-1 Virologically Suppressed on Bictegravir/Emtricitabine/Tenofovir Alafenamide (BIC/FTC/TAF) Once-Daily

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04564547
• Other study ID #: 8591-013
• Secondary ID: MK-8591-0132020-
• Status: Active, not recruiting
• Phase: Phase 2
• Start date: March 9, 2021
• Est. completion date: September 30, 2024

Study information

• Verified date: May 2024
• Source: Merck Sharp & Dohme LLC
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

As of protocol amendment 2 (approved 01-Dec-2021), all participants are unblinded and discontinued from study therapy, and will be switched to non-study antiretroviral therapy. Participants who received ISL + ulonivirine will be followed for ≥6 months.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 161
• Est. completion date: September 30, 2024
• Est. primary completion date: September 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Is HIV-1 positive with plasma HIV-1 RNA <50 copies/mL at screening

• Has been virologically suppressed on BIC/FTC/TAF for =6 months

• Has a screening CD4+ T-cell count >200 cells/mm^3 (completed by the central laboratory)

• Is male or female, at least 18 years of age, at the time of signing the informed consent

• female participant is eligible to participate if she is not pregnant or breastfeeding, and at least one of the following conditions applies:

• Is not a woman of childbearing potential (WOCBP)

• Is a WOCBP and using a contraceptive method that is highly effective (with a failure rate of <1% per year), or be abstinent from heterosexual intercourse as their preferred and usual lifestyle (abstinent on a long term and persistent basis)

Exclusion Criteria:

• Has HIV-2 infection

• Has hypersensitivity or other contraindication to any of the components of the study interventions as determined by the investigator

• Has active hepatitis C virus (HCV) coinfection (defined as detectable HCV RNA) or hepatitis B virus (HBV) coinfection (defined as hepatitis B surface antigen [HBsAg]-positive or HBV deoxyribonucleic acid [DNA] positive)

• Has a current (active) diagnosis of acute hepatitis due to any cause

• Has a history of malignancy =5 years prior to signing informed consent except for adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, or cutaneous Kaposi's sarcoma

• Has a history or current evidence of any condition (including active tuberculosis infection), therapy, laboratory abnormality or other circumstance (including drug or alcohol use or dependence) that might, in the opinion of the investigator, confound the results of the study or interfere with the participant's participation for the full duration of the study

• Is taking or is anticipated to require systemic immunosuppressive therapy, immune modulators, or any prohibited therapies

• Is currently participating in or has participated in a clinical study with an investigational compound or device from 45 days prior to Day 1 through the study treatment period

• Has a documented or known virological resistance to ulonivirine or nucleoside/nucleotide reverse transcriptase inhibitors (NNRTI)

• Is female and expecting to conceive or donate eggs at any time during the study

Related Conditions & MeSH terms

• HIV-1 Infection

Intervention

Drug:
• Islatravir
ISL capsule taken by mouth.
• Ulonivirine
Ulonivirine tablet taken by mouth.
• BIC/FTC/TAF
BIC/FTC/TAF tablet taken by mouth.
• Placebo to ISL
Placebo capsule matched to ISL taken by mouth.
• Placebo to Ulonivirine
Placebo tablet matched to ulonivirine taken by mouth.
• Placebo to BIC/FTC/TAF
Placebo tablet matched to BIC/FTC/TAF taken by mouth.

Locations

Country	Name	City	State
France	Hopital Avicenne ( Site 2305)	Bobigny	Seine-Saint-Denis
France	Hopital Gui de Chauliac. ( Site 2303)	Montpellier Cedex 5	Herault
France	CHU Hotel Dieu Nantes ( Site 2310)	Nantes	Loire-Atlantique
France	Centre Hospitalier Regional du Orleans ( Site 2304)	Orleans	Loiret
France	Hopital Saint Louis ( Site 2308)	Paris
France	Hopital Saint-Antoine ( Site 2307)	Paris
France	Pitie Salpetriere University Hospital-Infectious Disease - Tropical Diseases ( Site 2306)	Paris	Ile-de-France
France	CHU de Toulouse - Hopital Purpan ( Site 2302)	Toulouse	Haute-Garonne
Switzerland	Universitaetsspital Basel ( Site 2602)	Basel	Basel-Stadt
Switzerland	Inselspital Universitaetsspital Bern ( Site 2603)	Bern	Berne
Switzerland	Hopitaux Universitaires de Geneve HUG ( Site 2604)	Geneva	Geneve
Switzerland	CHUV (centre hospitalier universitaire vaudois) ( Site 2605)	Lausanne	Vaud
Switzerland	Universitaetsspital Zuerich ( Site 2601)	Zuerich	Aargau
United States	Saint Hope Foundation, Inc. ( Site 2716)	Bellaire	Texas
United States	Infectious Disease Specialists Of Atlanta PC ( Site 2704)	Decatur	Georgia
United States	Midway Immunology and Research ( Site 2713)	Fort Pierce	Florida
United States	Texas Centers for Infectious Disease Associates P.A. ( Site 2709)	Fort Worth	Texas
United States	Kansas City CARE Clinic ( Site 2703)	Kansas City	Missouri
United States	DCOL Center for Clinical Research ( Site 2715)	Longview	Texas
United States	Men's Health Foundation ( Site 2710)	Los Angeles	California
United States	Pueblo Family Physicians ( Site 2702)	Phoenix	Arizona
United States	Chatham County Health Department ( Site 2707)	Savannah	Georgia
United States	Triple O Research Institute, P.A. ( Site 2712)	West Palm Beach	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Merck Sharp & Dohme LLC

Countries where clinical trial is conducted

United States,  France,  Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of participants with =1 adverse event (AE)	The percentage of participants with AEs will be determined.	Up to =96 weeks
Primary	Percentage of participants discontinuing study intervention due to AE	The percentage of participants discontinuing due to AEs will be determined.	Up to =96 weeks

External Links

•   Merck Clinical Trials Information
•   Plain Language Summary