Islatravir + Ulonivirine for HIV

Recruiting at 22 trial locations

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Merck Sharp & Dohme Corp.

Must be taking: BIC/FTC/TAF

Must not be taking: Immunosuppressives, Immune modulators

Disqualifiers: HIV-2, Hepatitis C, Hepatitis B, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 96 weeks

161 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Research Team

Medical Director

Principal Investigator

Merck Sharp & Dohme LLC

Eligibility Criteria

Adults over 18 with HIV-1 who've been virologically suppressed for at least 6 months using BIC/FTC/TAF can join. They must have a CD4+ T-cell count >200 cells/mm^3 and an HIV-1 RNA <50 copies/mL. Women can't be pregnant, breastfeeding, or planning to conceive; they must use effective contraception or practice abstinence.

Inclusion Criteria

I am a woman of childbearing potential and use highly effective birth control or practice long-term abstinence.

I have been on BIC/FTC/TAF and my viral load has been low for over 6 months.

I am not pregnant or breastfeeding.

Exclusion Criteria

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

I am a woman and do not plan to get pregnant or donate eggs during the study.

I have an active hepatitis C or B infection.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive ISL + ulonivirine or placebo to ISL + ulonivirine, and BIC/FTC/TAF or placebo to BIC/FTC/TAF

96 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

≥6 months

Long-term follow-up

Participants who received ISL + ulonivirine will be followed for long-term safety and effectiveness

Up to 144 weeks

Treatment Details

Interventions

• BIC/FTC/TAF
• Islatravir
• Ulonivirine

Trial Overview The trial is testing the safety of Islatravir (ISL) + Ulonivirine in adults with HIV-1 compared to a placebo. Participants are randomly assigned to receive either the study drugs or placebos while their health data is closely monitored.

Participant Groups

Group I: Group 3: ISL 20 mg + Ulonivirine 400 mg Experimental Treatment 3 Interventions

Participants receive ISL 20 mg (Parts 1-3) + ulonivirine 400 mg QW and placebo to BIC/FTC/TAF QD (Part 1).

Group II: Group 2: ISL 20 mg + Ulonivirine 200 mg Experimental Treatment 4 Interventions

Participants receive ISL 20 mg (Parts 1-3) + ulonivirine 200 mg QW and placebo to BIC/FTC/TAF QD (Part 1).

Group III: Group 1: ISL 20 mg + Ulonivirine 100 mg Experimental Treatment 4 Interventions

Participants receive ISL 20 mg (Parts 1-3) + ulonivirine 100 mg once weekly (QW) and placebo to BIC/FTC/TAF once daily (QD) \[Part 1\].

Group IV: Group 4: BIC/FTC/TAF Active Control 3 Interventions

Participants receive placebo to ISL + placebo to ulonivirine QW (Part 1) and BIC/FTC/TAF 50 mg/200 mg/25 mg QD (Parts 1 and 2).

Who Is Running the Clinical Trial?

Merck Sharp & Dohme Corp.

Lead Sponsor

Trials

2,287

Recruited

4,582,000+

Chirfi Guindo

Merck Sharp & Dohme Corp.

Chief Medical Officer

Engineering degree from Ecole Centrale de Paris, MBA from New York University Stern School of Business

Robert M. Davis

Merck Sharp & Dohme Corp.

Chief Executive Officer since 2021

J.D. from Northwestern University Pritzker School of Law, MBA from Northwestern University Kellogg Graduate School of Management, Bachelor's in Finance from Miami University

Merck Sharp & Dohme LLC

Lead Sponsor

Trials

4,096

Recruited

5,232,000+

Chirfi Guindo

Merck Sharp & Dohme LLC

Chief Marketing Officer since 2022

Degree in Engineering from Ecole Centrale de Paris, MBA from New York University Stern School of Business

Robert M. Davis

Merck Sharp & Dohme LLC

Chief Executive Officer since 2021

JD from Northwestern University Pritzker School of Law, MBA from Northwestern University Kellogg Graduate School of Management, Bachelor's in Finance from Miami University