Dose Ranging, Switch Study of ISL and MK‑8507 Once-Weekly

Phase 2

Completed

• Conditions: HIV-1 Infection
• Interventions: Drug: islatravir; Drug: ulonivirine

• Registration Number: 2024-511041-19-00
• Lead Sponsor: Merck Sharp & Dohme LLC

Brief Summary

To evaluate the safety and tolerability of ISL + MK-8507 once-weekly as assessed by review of the accumulated safety data.

Detailed Description

Not available

Study Timeline

• Study First Posted: 2024-04-17
• Last Update Posted: 2025-01-29

Recruitment & Eligibility

• Status: Ended
• Sex: Not specified
• Target Recruitment: 48

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 participants are eligible to participate if she is not pregnant or breastfeeding, and at least one of the following conditions applies: a) is not a woman of childbearing potential (WOCBP), or b) 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

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

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)

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
islatravir	islatravir	Participants receiving islatravir
ulonivirine	ulonivirine	Participants receiving ulonivirine

Primary Outcome Measures

Name	Time	Method
Percentage of participants with ≥1 adverse event (AE)		Percentage of participants with ≥1 adverse event (AE)
Percentage of participants discontinuing study intervention due to AE		Percentage of participants discontinuing study intervention due to AE

Secondary Outcome Measures

Name	Time	Method
NA		NA

Trial Locations

Locations (3)

Hopital Saint Antoine; 🇫🇷 Paris Cedex 12, France

Hopital Saint Louis; 🇫🇷 Paris, France

Centre Hospitalier Universitaire D Orleans; 🇫🇷 Orleans Cedex 1, France

Hopital Saint Antoine

🇫🇷Paris Cedex 12, France

Karine Lacombe

Site contact

0033149282445

karine.lacombe2@aphp.fr