HIV-1Phase 2NCT07862569
DOR/ISL in Pediatric Participants With HIV-1, <18 Years of Age and ≥ 35 kg
A Phase 2 study testing DOR/ISL in people with HIV-1 and HIV Infection, run by Merck Sharp & Dohme LLC.
Trial summary
This is a phase 2 study of the pharmacokinetics, safety, and efficacy of oral doravirine/islatravir (100 mg/0.25 mg) [MK-8591A] in pediatric participants with human immunodeficiency virus type 1 (HIV-1) infection who are virologically suppressed or treatment-naive. The Base Study will last from Day 1 to Week 96. Read more about this study
- Who is it for?
- Ages Up to 18 years
- Conditions the study is for
- HIV-1, HIV Infection
- What is being tested?
- DOR/ISL
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- No sites listed yet
- Study dates
- 23 Dec 2026to 23 Dec 2033
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Pediatric participant with HIV-1 <18 years of age
- Body weight ≥35 kg
- Is TN (HIV-1 positive with plasma HIV-1 RNA ≥500 copies/mL) or VS (HIV-1 positive at screening with plasma HIV-1 RNA <50 copies/mL AND has received stable, continuous 2- or 3-drug antiretroviral therapy (ART) for ≥3 months prior to providing informed consent)
Who cannot join
- HIV-2 infection
- Hypsensitivity/contraindication to any components of study medication or as determined by the investigator
- Has an active diagnosis of hepatitis due to any cause
- 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, COVID-19, or other infections), 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
- Is taking or is anticipated to require systemic immunosuppressive therapy, immune modulators, or any prohibited therapies
About this study
Official title: A Phase 2 Clinical Study to Evaluate the Pharmacokinetics, Safety, and Efficacy of Oral Doravirine/Islatravir (100 mg/0.25 mg) in Pediatric Participants With HIV-1 Infection Who Are Virologically Suppressed or Treatment-Naïve, Are Less Than 18 Years of Age, and Weigh Greater Than or Equal to 35 kg
This is a phase 2 study of the pharmacokinetics, safety, and efficacy of oral doravirine/islatravir (100 mg/0.25 mg) [MK-8591A] in pediatric participants with human immunodeficiency virus type 1 (HIV-1) infection who are virologically suppressed or treatment-naive.
The Base Study will last from Day 1 to Week 96. At Week 96, participants will be given the option to participate in an optional Study Extension and receive DOR/ISL until Week 240 or until it becomes commercially accessible, whichever is first.
- Conditions
- HIV-1, HIV Infection
- Being tested
- DOR/ISL
- Medical subject headings
- HIV Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DOR/ISLDrug
Also called MK-8591A
DOR/ISL 100 mg/0.25 mg tablet taken by mouth qd
| Study group | Role | What they receive |
|---|---|---|
| DOR/ISL | Experimental | Participants receive DOR/ISL 100 mg/0.25 mg once daily (qd) for 96 weeks. Participants will have the option to participate in the Study Extension and receive DOR/ISL until Week 240 or it becomes commercially available, whichever is first. Receives: Drug: DOR/ISL |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area under the plasma conentration-time curve from dosing to 24 hours postdose (AUC0-24) of ISL
The plasma AUC0-24 will be assessed.
Measured: At designated timepoints on Day 28
Maximum plasma concentration (Cmax) of ISL
The plasma Cmax will be assessed.
Measured: At designated timepoints on Day 28
Time to maximum plasma concentration (Tmax) of ISL
The plasma Tmax will be assessed.
Measured: At designated timepoints on Day 28
Apparent plasma terminal half-life (t½) of ISL
The plasma t½ will be assessed.
Measured: At designated timepoints on Day 28
Apparent clearance (CL/F) of ISL
The CL/F will be assessed.
Measured: At designated timepoints on Day 28
Volume of distribution (Vz/F) of ISL
The Vz/F will be assessed.
Measured: At designated timepoints on Day 28
Percentage of participants with ≥1 adverse event (AE) through Week 24
The percentage of participants with AE(s) will be assessed.
Measured: Up to ~24 weeks
Percentage of participants discontinuing from study therapy due to AE(s) through Week 24
The percentage of participants discontinuing from therapy due to AE(s) will be assessed.
Measured: Up to ~24 weeks
Secondary outcomes (9)
Percentage of participants with ≥1 AE through Week 96
The percentage of participants with AE(s) will be assessed.
Measured: Up to 96 weeks
Percentage of participants discontinuing from study therapy due to AE(s) through Week 96
The percentage of participants with AE(s) will be assessed.
Measured: Up to 96 weeks
Percentage of virologically-suppressed (VS) participants with Human Immunodeficiency Virus Type 1 (HIV-1) ribonucleic acid (RNA) ≥50 copies/mL
The percentage of VS participants with HIV-1 RNA ≥50 copies/mL will be assessed.
Measured: Weeks 24, 48, and 96
Percentage of VS participants with HIV-1 RNA <50 copies/mL
The percentage of VS participants with HIV-1 RNA <50 copies/mL will be assessed.
Measured: Weeks 24, 48, and 96
Percentage of VS participants with HIV-1 RNA <200 copies/mL
The percentage of VS participants with HIV-1 RNA <200 copies/mL will be assessed.
Measured: Weeks 24, 48, and 96
Percentage of treatment-naive (TN) participants with HIV-1 RNA <50 copies/mL
The percentage of TN participants with HIV-1 RNA <50 copies/mL will be assessed.
Measured: Weeks 24, 48, and 96
Percentage of TN participants with HIV-1 RNA <200 copies/mL
The percentage of TN participants with HIV-1 RNA <200 copies/mL will be assessed.
Measured: Weeks 24, 48, and 96
Change from baseline in CD4+ T-cell counts in VS and TN participants
The change from baseline in CD4+ T-cell counts will be assessed in VS and TN participants.
Measured: Weeks 24, 48, and 96
Percentage of participants with viral drug resistance to DOR or ISL
The percentage of participants with viral resistance-associated substitutions will be assessed during Weeks 24, 48, 96, and 144.
Measured: Weeks 24, 48, 96, and 144
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Oct 2026
- Study start23 Dec 2026 (estimated)
- Primary completion24 Sep 2029 (estimated)
- Study completion23 Dec 2033 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIV-1Studies of the same condition, open and under way.
- More trials run by Merck Sharp & Dohme LLCThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Merck Sharp & Dohme LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07862569
- Sponsor's protocol ID
- 8591A-063
- Status last verified
- Sep 2026
- First submitted
- 2 Oct 2026
- Last updated
- 7 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: https://trialstransparency.msdclinicaltrials.com/pdf/ProcedureAccessClinicalTrialData.pdf
Study at a glance
From the registry record, last updated by the sponsor on 7 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2 Clinical Study to Evaluate the Pharmacokinetics, Safety, and Efficacy of Oral Doravirine/Islatravir (100 mg/0.25 mg) in Pediatric Participants With HIV-1 Infection Who Are Virologically Suppressed or Treatment-Naïve, Are Less Than 18 Years of Age, and Weigh Greater Than or Equal to 35 kg
- ClinicalTrials.gov ID
- NCT07862569
- Acronym / sponsor ID
- 8591A-063
- Conditions
- HIV-1, HIV Infection
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
- Study start
- 23 Dec 2026 (estimated)
- Primary completion
- 24 Sep 2029 (estimated)
- Study completion
- 23 Dec 2033 (estimated)
- First posted
- 7 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a phase 2 study of the pharmacokinetics, safety, and efficacy of oral doravirine/islatravir (100 mg/0.25 mg) [MK-8591A] in pediatric participants with human immunodeficiency virus type 1 (HIV-1) infection who are virologically suppressed or treatment-naive.
The Base Study will last from Day 1 to Week 96. At Week 96, participants will be given the option to participate in an optional Study Extension and receive DOR/ISL until Week 240 or until it becomes commercially accessible, whichever is first.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| DOR/ISL | Experimental | Drug: DOR/ISLParticipants receive DOR/ISL 100 mg/0.25 mg once daily (qd) for 96 weeks. Participants will have the option to participate in the Study Extension and receive DOR/ISL until Week 240 or it becomes commercially available, whichever is first. |
Who may qualify
- Ages
- Up to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- Pediatric participant with HIV-1 <18 years of age
- Body weight ≥35 kg
- Is TN (HIV-1 positive with plasma HIV-1 RNA ≥500 copies/mL) or VS (HIV-1 positive at screening with plasma HIV-1 RNA <50 copies/mL AND has received stable, continuous 2- or 3-drug antiretroviral therapy (ART) for ≥3 months prior to providing informed consent)
Key exclusion criteria (6 listed)
- HIV-2 infection
- Hypsensitivity/contraindication to any components of study medication or as determined by the investigator
- Has an active diagnosis of hepatitis due to any cause
- 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, COVID-19, or other infections), 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DOR/ISLAlso: MK-8591ADOR/ISL 100 mg/0.25 mg tablet taken by mouth qd | Drug | DOR/ISL |
Primary outcome
Area under the plasma conentration-time curve from dosing to 24 hours postdose (AUC0-24) of ISL
Time frame: At designated timepoints on Day 28
The plasma AUC0-24 will be assessed.
Maximum plasma concentration (Cmax) of ISL
Time frame: At designated timepoints on Day 28
The plasma Cmax will be assessed.
Time to maximum plasma concentration (Tmax) of ISL
Time frame: At designated timepoints on Day 28
The plasma Tmax will be assessed.
Apparent plasma terminal half-life (t½) of ISL
Time frame: At designated timepoints on Day 28
The plasma t½ will be assessed.
Apparent clearance (CL/F) of ISL
Time frame: At designated timepoints on Day 28
The CL/F will be assessed.
Volume of distribution (Vz/F) of ISL
Time frame: At designated timepoints on Day 28
The Vz/F will be assessed.
Percentage of participants with ≥1 adverse event (AE) through Week 24
Time frame: Up to ~24 weeks
The percentage of participants with AE(s) will be assessed.
Percentage of participants discontinuing from study therapy due to AE(s) through Week 24
Time frame: Up to ~24 weeks
The percentage of participants discontinuing from therapy due to AE(s) will be assessed.
9 secondary outcomes
Percentage of participants with ≥1 AE through Week 96
Time frame: Up to 96 weeks
Percentage of participants discontinuing from study therapy due to AE(s) through Week 96
Time frame: Up to 96 weeks
Percentage of virologically-suppressed (VS) participants with Human Immunodeficiency Virus Type 1 (HIV-1) ribonucleic acid (RNA) ≥50 copies/mL
Time frame: Weeks 24, 48, and 96
Percentage of VS participants with HIV-1 RNA <50 copies/mL
Time frame: Weeks 24, 48, and 96
Percentage of VS participants with HIV-1 RNA <200 copies/mL
Time frame: Weeks 24, 48, and 96
Percentage of treatment-naive (TN) participants with HIV-1 RNA <50 copies/mL
Time frame: Weeks 24, 48, and 96
Percentage of TN participants with HIV-1 RNA <200 copies/mL
Time frame: Weeks 24, 48, and 96
Change from baseline in CD4+ T-cell counts in VS and TN participants
Time frame: Weeks 24, 48, and 96
Percentage of participants with viral drug resistance to DOR or ISL
Time frame: Weeks 24, 48, 96, and 144
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Oct 2026.
- Merck Clinical Trials InformationLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. https://trialstransparency.msdclinicaltrials.com/pdf/ProcedureAccessClinicalTrialData.pdf
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing DOR/ISL in people with HIV-1 and HIV Infection, run by Merck Sharp & Dohme LLC.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 7 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Area under the plasma conentration-time curve from dosing to 24 hours postdose (AUC0-24) of ISL (time frame: At designated timepoints on Day 28). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Oct 2026.