A clinical study of islatravir and ulonivirine for people with HIV-1 who have not been treated before (MK-8591B-062)

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Merck Sharp & Dohme LLC

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Virus Diseases [C02]

Trial duration

16 Mar 2026 → ongoing

Decision date (initial)

2026-02-16

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

No

Funding sources

Merck Sharp & Dohme LLC

External identifiers

EU CT number

2025-522519-40-00

WHO UTN

U1111-1323-4689

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Safety, Efficacy, Therapy, Pharmacokinetic

1. Phase 2: To evaluate the antiretroviral activity of ISL+ULO qw compared to BIC/FTC/TAF qd, as assessed by the percentage of participants with HIV-1 RNA <50 copies/mL at Week 24
2. Phase 2: To evaluate the safety and tolerability of ISL+ULO qw compared to BIC/FTC/TAF qd, as assessed by review of accumulated safety data through Week 24
3. Phase 3: To evaluate the antiretroviral activity of ISL/ULO qw compared to BIC/FTC/TAF qd, as assessed by the percentage of participants with HIV-1 RNA <50 copies/mL at Week 48
4. Phase 3: To evaluate the safety and tolerability of ISL/ULO qw compared with BIC/FTC/TAF qd, as assessed by review of accumulated safety data through Week 48

Secondary objectives 9

1. Phase 2: To evaluate the antiretroviral activity of ISL+ULO qw compared to BIC/FTC/TAF qd, as assessed by the percentage of participants with: - HIV-1 RNA <50 copies/mL at Week 48 and Week 96 - HIV-1 RNA <200 copies/mL at Week 24, Week 48, and Week 96
2. Phase 2: To evaluate the immunologic effect of ISL+ULO qw compared to BIC/FTC/TAF qd, as assessed by the mean change from baseline in CD4+ T-cell count at Week 24, Week 48, and Week 96
3. Phase 2: To evaluate the safety and tolerability of ISL+ULO qw compared to BIC/FTC/TAF qd, as assessed by review of accumulated safety data through the end of Phase 2 of the study
4. Phase 2: To evaluate the development of viral drug resistance in participants who receive ISL+ULO qw and in participants who receive BIC/FTC/TAF qd
5. Phase 3: To evaluate the antiretroviral activity of ISL/ULO qw compared to BIC/FTC/TAF qd, as assessed by the percentage of participants with: - HIV-1 RNA <50 copies/mL at Week 96 - HIV-1 RNA <200 copies/mL at Week 48 and Week 96
6. Phase 3: To evaluate the immunologic effect of ISL/ULO qw compared to BIC/FTC/TAF qd, as assessed by the mean change from baseline in CD4+ T-cell count at Week 48 and Week 96
7. Phase 3: To evaluate the safety and tolerability of ISL/ULO qw compared to BIC/FTC/TAF qd, as assessed by review of accumulated safety data through the end of the study
8. Phase 3: To evaluate the development of viral drug resistance in participants who receive ISL/ULO qw and in participants who receive BIC/FTC/TAF qd
9. Phase 3: To evaluate the effect of ISL/ULO qw compared to BIC/FTC/TAF qd on weight, as assessed by the mean change from baseline at Week 48 and Week 96

Conditions and MedDRA coding

HIV

Regulatory references

Scientific advice from competent authorities

European Medicines Agency

Plan to share IPD

Yes

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 3

1. Is human immunodeficiency virus type 1 (HIV-1) positive with: - Phase 2: Plasma HIV-1 ribonucleic acid (RNA) ≥500 and ≤100,000 copies/mL. - Phase 3: Plasma HIV-1 RNA ≥500 copies/mL.
2. Phase 2: Has cluster of differentiation 4-positive (CD4+) T-cell count ≥200 cells/mm^3.
3. Is naïve to antiretroviral therapy (ART), defined as having received no prior therapy with any antiretroviral agent following a diagnosis of HIV 1 infection.

Exclusion criteria 5

1. Has human immunodeficiency virus type 2 (HIV-2) infection.
2. Has a diagnosis of an active acquired immune deficiency syndrome (AIDS)-defining opportunistic infection.
3. Has active hepatitis C virus (HCV) or active hepatitis B virus (HBV) infection.
4. Has a history of malignancy ≤5 years prior to providing documented informed consent except for adequately treated basal cell or squamous cell skin cancer, in situ cervical or in situ anal cancer, or cutaneous Kaposi’s sarcoma.
5. Has prior exposure to islatravir (ISL) or ulonivirine (ULO) for any duration any time prior to Day 1.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 6

1. Phase 2: Percentage of Participants With Human Immunodeficiency Virus Type 1 (HIV-1) Ribonucleic Acid (RNA) <50 Copies/mL at Week 24
2. Phase 2: Percentage of Participants Who Experience an Adverse Event (AE) at Week 24
3. Phase 2: Percentage of Participants Who Discontinue Study Intervention Due to an AE at Week 24
4. Phase 3: Percentage of Participants With HIV-1 RNA <50 Copies/mL at Week 48
5. Phase 3: Percentage of Participants Who Experience an AE at Week 48
6. Phase 3: Percentage of Participants Who Discontinue Study Intervention Due to an AE at Week 48

Secondary endpoints 24

1. Phase 2: Percentage of Participants With HIV-1 RNA <50 Copies/mL at Week 48
2. Phase 2: Percentage of Participants With HIV-1 RNA <50 Copies/mL at Week 96
3. Phase 2: Percentage of Participants With HIV-1 RNA <200 Copies/mL at Week 24
4. Phase 2: Percentage of Participants With HIV-1 RNA <200 Copies/mL at Week 48
5. Phase 2: Percentage of Participants With HIV-1 RNA <200 Copies/mL at Week 96
6. Phase 2: Mean Change From Baseline in Cluster of Differentiation 4-Positive (CD4+) T-Cell Count at Week 24
7. Phase 2: Mean Change From Baseline in CD4+ T-Cell Count at Week 48
8. Phase 2: Mean Change From Baseline in CD4+ T-Cell Count at Week 96
9. Phase 2: Percentage of Participants Who Experience an AE
10. Phase 2: Percentage of Participants Who Discontinue Study Intervention Due to an AE
11. Phase 2: Number of Participants With Evidence of Viral Drug Resistance-Associated Substitutions at Week 24
12. Phase 2: Number of Participants With Evidence of Viral Drug Resistance-Associated Substitutions at Week 48
13. Phase 2: Number of Participants With Evidence of Viral Drug Resistance-Associated Substitutions at Week 96
14. Phase 3: Percentage of Participants With HIV-1 RNA <50 Copies/mL at Week 96
15. Phase 3: Percentage of Participants With HIV-1 RNA <200 Copies/mL at Week 48
16. Phase 3: Percentage of Participants With HIV-1 RNA <200 Copies/mL at Week 96
17. Phase 3: Mean Change From Baseline in CD4+ T-Cell Count at Week 48
18. Phase 3: Mean Change From Baseline in CD4+ T-Cell Count at Week 96
19. Phase 3: Percentage of Participants Who Experience an AE
20. Phase 3: Percentage of Participants Who Discontinue Study Intervention Due to an AE
21. Phase 3: Number of Participants With Evidence of Viral Drug Resistance-Associated Substitutions at Week 48
22. Phase 3: Number of Participants With Evidence of Viral Drug Resistance-Associated Substitutions at Week 96
23. Phase 3: Mean Change From Baseline in Body Weight at Week 48
24. Phase 3: Mean Change From Baseline in Body Weight at Week 96

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 3

Comparator 1

Placebo 2

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Merck Sharp & Dohme LLC

Sponsor organisation

Merck Sharp & Dohme LLC

Address

126 East Lincoln Avenue, P. O. Box 2000 P. O. Box 2000

City

Rahway

Postcode

07065-4607

Country

United States

Scientific contact point

Organisation

Merck Sharp & Dohme LLC

Contact name

Randolph Matthews

Public contact point

Organisation

Merck Sharp & Dohme LLC

Contact name

Randolph Matthews

Third parties 7

Locations

2 EU/EEA countries · 25 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 14 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

1 submissions — initial application plus substantial / non-substantial modifications