HIV-1 InfectionPhase 2NCT04564547
Dose Ranging, Switch Study of Islatravir (MK-8591) and Ulonivirine (MK-8507) Once-Weekly in Virologically-Suppressed Adults With Human Immunodeficiency Virus Type 1 (HIV-1) [MK-8591-013]
A Phase 2 study testing Islatravir, Ulonivirine and BIC/FTC/TAF in people with HIV-1 Infection, run by Merck Sharp & Dohme LLC at 23 sites in 3 countries.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HIV-1 Infection
- What is being tested?
- Islatravir, Ulonivirine and BIC/FTC/TAF
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 161 participants
- Where
- 23 sitesin 3 countries
- Study dates
- 9 Mar 2021to 30 Jan 2025
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Is HIV-1 positive with plasma human immunodeficiency virus type 1 (HIV-1) RNA <50 copies/mL at screening
- Has been virologically suppressed on bictegravir/emtricitabine/tenofovir alafenamide (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 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)
Who cannot join
- 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
Show all 10Show fewer
- 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
Trial locations and contacts
23 sites in 3 countries.
23 sites in 3 countries
United States10 sites
Saint Hope Foundation, Inc. ( Site 2716)
Bellaire, Texas, 77401
Infectious Disease Specialists Of Atlanta PC ( Site 2704)
Decatur, Georgia, 30033
Texas Centers for Infectious Disease Associates P.A. ( Site 2709)
Fort Worth, Texas, 76104
Midway Immunology and Research ( Site 2713)
Ft. Pierce, Florida, 34982
Kansas City CARE Clinic ( Site 2703)
Kansas City, Missouri, 64111
DCOL Center for Clinical Research ( Site 2715)
Longview, Texas, 75605
Men's Health Foundation ( Site 2710)
Los Angeles, California, 90069
Pueblo Family Physicians ( Site 2702)
Phoenix, Arizona, 85015
Chatham County Health Department ( Site 2707)
Savannah, Georgia, 31410
Triple O Research Institute, P.A. ( Site 2712)
West Palm Beach, Florida, 33407
France8 sites
Hopital Avicenne ( Site 2305)
Bobigny, Seine-Saint-Denis, 93000
Hopital Gui de Chauliac. ( Site 2303)
Montpellier, Herault, 34295
CHU Hotel Dieu Nantes ( Site 2310)
Nantes, Loire-Atlantique, 44093
Centre Hospitalier Regional du Orleans ( Site 2304)
Orléans, Loiret, 45100
Hopital Saint Louis ( Site 2308)
Paris, 75010
Hopital Saint-Antoine ( Site 2307)
Paris, 75012
Pitie Salpetriere University Hospital-Infectious Disease - Tropical Diseases ( Site 2306)
Paris, Île-de-France Region, 75013
CHU de Toulouse - Hopital Purpan ( Site 2302)
Toulouse, Haute-Garonne, 31059
Switzerland5 sites
Universitaetsspital Basel ( Site 2602)
Basel, Canton of Basel-City, 4031
Inselspital Universitaetsspital Bern ( Site 2603)
Bern, Canton of Bern, 3010
Hopitaux Universitaires de Geneve HUG ( Site 2604)
Geneva, Canton of Geneva, 1211
CHUV (centre hospitalier universitaire vaudois) ( Site 2605)
Lausanne, Canton of Vaud, 1011
Universitaetsspital Zuerich ( Site 2601)
Zuerich, Canton of Aargau, 8091
About this study
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
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.
Read the detailed description
Based on laboratory findings of decreased lymphocyte and CD4+ T-cell counts across the islatravir program and as described in protocol amendment 2 (approved 01-Dec-2021), participants in study Part 1 (double-blind treatment period) were unblinded, discontinued all study interventions, and switched to standard of care non-study antiretroviral (ART) therapy. Participants who received ISL + ulonivirine (Groups 1 to 3) may have then entered into an unblinded safety monitoring period and were monitored for ≥6 months. As specified in protocol amendment 2, study Parts 2 and 3 were no longer planned or initiated for any participant.
- Conditions
- HIV-1 Infection
- Being tested
- Islatravir, Ulonivirine, BIC/FTC/TAF, Placebo to ISL, Placebo to Ulonivirine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IslatravirDrug
Also called MK-8591
ISL capsule taken by mouth.
UlonivirineDrug
Also called MK-8507
Ulonivirine tablet taken by mouth.
BIC/FTC/TAFDrug
Also called BIKTARVY®
BIC/FTC/TAF tablet taken by mouth.
Placebo to ISLDrug
Placebo capsule matched to ISL taken by mouth.
Placebo to UlonivirineDrug
Placebo tablet matched to ulonivirine taken by mouth.
Placebo to BIC/FTC/TAFDrug
Placebo tablet matched to BIC/FTC/TAF taken by mouth.
| Study group | Role | What they receive |
|---|---|---|
| Group 1: ISL 20 mg + Ulonivirine 100 mg | Experimental | Participants receive ISL 20 mg + ulonivirine 100 mg once weekly (QW) and placebo to BIC/FTC/TAF once daily (QD). Following study-wide discontinuation of study intervention, participants may have entered the optional unblinded safety monitoring period and received standard of care non-study ART. Receives: Drug: Islatravir; Drug: Ulonivirine; Drug: Placebo to Ulonivirine; Drug: Placebo to BIC/FTC/TAF |
| Group 2: ISL 20 mg + Ulonivirine 200 mg | Experimental | Participants receive ISL 20 mg + ulonivirine 200 mg QW and placebo to BIC/FTC/TAF QD. Following study-wide discontinuation of study intervention, participants may have entered the optional unblinded safety monitoring period and received standard of care non-study ART. Receives: Drug: Islatravir; Drug: Ulonivirine; Drug: Placebo to Ulonivirine; Drug: Placebo to BIC/FTC/TAF |
| Group 3: ISL 20 mg + Ulonivirine 400 mg | Experimental | Participants receive ISL 20 mg + ulonivirine 400 mg QW and placebo to BIC/FTC/TAF QD. Following study-wide discontinuation of study intervention, participants may have entered the optional unblinded safety monitoring period and received standard of care non-study ART. Receives: Drug: Islatravir; Drug: Ulonivirine; Drug: Placebo to BIC/FTC/TAF |
| Group 4: BIC/FTC/TAF | Active comparator | Participants receive placebo to ISL + placebo to ulonivirine QW and BIC/FTC/TAF 50 mg/200 mg/25 mg QD. Receives: Drug: BIC/FTC/TAF; Drug: Placebo to ISL; Drug: Placebo to Ulonivirine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants Who Experienced One or More Adverse Events (AEs) During the Double-Blind Treatment Period +42 Days Post-Blind
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. As pre-specified in the protocol and supplemental statistical analysis plan (sSAP), presented here is the percentage of participants who experienced one or more AEs during the Double-blind Treatment Period and includes the 42 days following the final dose of double-blind study intervention.
Measured: Up to approximately 9 months
Percentage of Participants Who Discontinued Study Intervention Due to an AE During the Double-Blind Treatment Period
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. As pre-specified in the protocol and sSAP, presented here is the percentage of participants who discontinued double-blind study intervention due to an AE during the Double-Blind Treatment Period.
Measured: Up to approximately 8 months
Percentage of Participants Who Experienced One or More AEs During the Unblinded Safety Monitoring Period
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. As pre-specified in the protocol and sSAP, presented here is the percentage of participants who experienced one or more AEs during the Unblinded Safety Monitoring Period, beginning 42 days following the final dose of double-blind study intervention.
Measured: Up to approximately 37 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2020
- Study start9 Mar 2021
- Primary completion30 Jan 2025
- Study completion30 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for HIV-1 InfectionStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 161 participants (actual)
Sponsor and investigators
- Lead sponsor
- Merck Sharp & Dohme LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Director, Study director, Merck Sharp & Dohme LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04564547
- Sponsor's protocol ID
- 8591-013
- Other IDs
- MK-8591-013, 2024-511041-19-00, U1111-1302-9886, 2020-003071-18
- Status last verified
- Jan 2026
- First submitted
- 21 Sep 2020
- Last updated
- 26 Jan 2026
- Results posted
- Yes, on ClinicalTrials.gov
- 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 26 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04564547
- Acronym / sponsor ID
- 8591-013
- Conditions
- HIV-1 Infection
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 161 participants (actual)
- Lead sponsor
- Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
- Study start
- 9 Mar 2021 (actual)
- Primary completion
- 30 Jan 2025 (actual)
- Study completion
- 30 Jan 2025 (actual)
- First posted
- 25 Sep 2020 (actual)
- Results
- Posted 26 Jan 2026
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 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.
Detailed description
Based on laboratory findings of decreased lymphocyte and CD4+ T-cell counts across the islatravir program and as described in protocol amendment 2 (approved 01-Dec-2021), participants in study Part 1 (double-blind treatment period) were unblinded, discontinued all study interventions, and switched to standard of care non-study antiretroviral (ART) therapy. Participants who received ISL + ulonivirine (Groups 1 to 3) may have then entered into an unblinded safety monitoring period and were monitored for ≥6 months. As specified in protocol amendment 2, study Parts 2 and 3 were no longer planned or initiated for any participant.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Group 1: ISL 20 mg + Ulonivirine 100 mg | Experimental | Drug: Islatravir, Drug: Ulonivirine, Drug: Placebo to Ulonivirine, Drug: Placebo to BIC/FTC/TAFParticipants receive ISL 20 mg + ulonivirine 100 mg once weekly (QW) and placebo to BIC/FTC/TAF once daily (QD). Following study-wide discontinuation of study intervention, participants may have entered the optional unblinded safety monitoring period and received standard of care non-study ART. |
| Group 2: ISL 20 mg + Ulonivirine 200 mg | Experimental | Drug: Islatravir, Drug: Ulonivirine, Drug: Placebo to Ulonivirine, Drug: Placebo to BIC/FTC/TAFParticipants receive ISL 20 mg + ulonivirine 200 mg QW and placebo to BIC/FTC/TAF QD. Following study-wide discontinuation of study intervention, participants may have entered the optional unblinded safety monitoring period and received standard of care non-study ART. |
| Group 3: ISL 20 mg + Ulonivirine 400 mg | Experimental | Drug: Islatravir, Drug: Ulonivirine, Drug: Placebo to BIC/FTC/TAFParticipants receive ISL 20 mg + ulonivirine 400 mg QW and placebo to BIC/FTC/TAF QD. Following study-wide discontinuation of study intervention, participants may have entered the optional unblinded safety monitoring period and received standard of care non-study ART. |
| Group 4: BIC/FTC/TAF | Active comparator | Drug: BIC/FTC/TAF, Drug: Placebo to ISL, Drug: Placebo to UlonivirineParticipants receive placebo to ISL + placebo to ulonivirine QW and BIC/FTC/TAF 50 mg/200 mg/25 mg QD. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Is HIV-1 positive with plasma human immunodeficiency virus type 1 (HIV-1) RNA <50 copies/mL at screening
- Has been virologically suppressed on bictegravir/emtricitabine/tenofovir alafenamide (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 not pregnant or breastfeeding, and at least one of the following conditions applies:
Key exclusion criteria (10 listed)
- 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
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 |
|---|---|---|
| IslatravirAlso: MK-8591ISL capsule taken by mouth. | Drug | Group 1: ISL 20 mg + Ulonivirine 100 mg, Group 2: ISL 20 mg + Ulonivirine 200 mg, Group 3: ISL 20 mg + Ulonivirine 400 mg |
| UlonivirineAlso: MK-8507Ulonivirine tablet taken by mouth. | Drug | Group 1: ISL 20 mg + Ulonivirine 100 mg, Group 2: ISL 20 mg + Ulonivirine 200 mg, Group 3: ISL 20 mg + Ulonivirine 400 mg |
| BIC/FTC/TAFAlso: BIKTARVY®BIC/FTC/TAF tablet taken by mouth. | Drug | Group 4: BIC/FTC/TAF |
| Placebo to ISLPlacebo capsule matched to ISL taken by mouth. | Drug | Group 4: BIC/FTC/TAF |
| Placebo to UlonivirinePlacebo tablet matched to ulonivirine taken by mouth. | Drug | Group 1: ISL 20 mg + Ulonivirine 100 mg, Group 2: ISL 20 mg + Ulonivirine 200 mg, Group 4: BIC/FTC/TAF |
| Placebo to BIC/FTC/TAFPlacebo tablet matched to BIC/FTC/TAF taken by mouth. | Drug | Group 1: ISL 20 mg + Ulonivirine 100 mg, Group 2: ISL 20 mg + Ulonivirine 200 mg, Group 3: ISL 20 mg + Ulonivirine 400 mg |
Primary outcome
Percentage of Participants Who Experienced One or More Adverse Events (AEs) During the Double-Blind Treatment Period +42 Days Post-Blind
Time frame: Up to approximately 9 months
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. As pre-specified in the protocol and supplemental statistical analysis plan (sSAP), presented here is the percentage of participants who experienced one or more AEs during the Double-blind Treatment Period and includes the 42 days following the final dose of double-blind study intervention.
Percentage of Participants Who Discontinued Study Intervention Due to an AE During the Double-Blind Treatment Period
Time frame: Up to approximately 8 months
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. As pre-specified in the protocol and sSAP, presented here is the percentage of participants who discontinued double-blind study intervention due to an AE during the Double-Blind Treatment Period.
Percentage of Participants Who Experienced One or More AEs During the Unblinded Safety Monitoring Period
Time frame: Up to approximately 37 months
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. As pre-specified in the protocol and sSAP, presented here is the percentage of participants who experienced one or more AEs during the Unblinded Safety Monitoring Period, beginning 42 days following the final dose of double-blind study intervention.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jan 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Merck Clinical Trials InformationLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. https://trialstransparency.msdclinicaltrials.com/pdf/ProcedureAccessClinicalTrialData.pdf
Related trials for HIV-1 Infection
RecruitingObservational study
Cohort of Women Living With HIV-1 and Receiving Bictegravir/Emtricitabine/Tenofovir Alafenamide
HIV (Human Immunodeficiency Virus), Pregnancy
RecruitingPhase 4
A Study to Provide Continued Access to Study Drug to Children and Adolescents Who Have Completed Clinical Studies Involving Gilead HIV Treatments
HIV-1-infection
RecruitingObservational study
Leukapheresis Procedures to Obtain Plasma and Lymphocytes for Research Studies on Antiretroviral Naive HIV-1 Research Participants
HIV
Active, not recruitingPhase 3
Study to Compare Bictegravir/Lenacapavir Versus Current Therapy in People With HIV-1 Who Are Successfully Treated With Biktarvy
HIV-1-infection
Active, not recruitingPhase 2/3
Study to Compare Bictegravir/Lenacapavir Versus Current Therapy in People With HIV-1 Who Are Successfully Treated With a Complicated Regimen (ARTISTRY-1)
HIV-1-infection
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. This study is not recruiting at the moment.
Medical Director study director
Merck Sharp & Dohme LLC
23 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Islatravir, Ulonivirine and BIC/FTC/TAF in people with HIV-1 Infection, run by Merck Sharp & Dohme LLC at 23 sites in 3 countries.
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 7 inclusion and 10 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: finished, as of the sponsor's last update on 26 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 23 sites in United States, France, Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Yes. Results are posted in the registry (first posted 26 Jan 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Percentage of Participants Who Experienced One or More Adverse Events (AEs) During the Double-Blind Treatment Period +42 Days Post-Blind (time frame: Up to approximately 9 months). The study lists 3 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 26 Jan 2026.