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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT05705349




Registration number
NCT05705349
Ethics application status
Date submitted
20/01/2023
Date registered
30/01/2023
Date last updated
27/06/2024

Titles & IDs
Public title
DOR/ISL in HIV-1 Antiretroviral Treatment-naïve Participants (MK-8591A-053)
Scientific title
A Phase 3, Randomized, Active-Controlled, Double-Blind Clinical Study to Evaluate the Antiretroviral Activity, Safety, and Tolerability of Doravirine/Islatravir (DOR/ISL 100 mg/0.25 mg) Once-Daily in HIV-1 Infected Treatment-Naïve Participants
Secondary ID [1] 0 0
2022-502099-22-00
Secondary ID [2] 0 0
8591A-053
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
HIV-1 Infection 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - DOR/ISL
Treatment: Drugs - BIC/FTC/TAF
Treatment: Drugs - Placebo to DOR/ISL
Treatment: Drugs - Placebo to BIC/FTC/TAF

Experimental: DOR/ISL - Participants take DOR/ISL and placebo to BIC/FTC/TAF once daily (qd) for 96 weeks.

Active comparator: BIC/FTC/TAF - Participants take BIC/FTC/TAF and placebo to DOR/ISL qd for 96 weeks.


Treatment: Drugs: DOR/ISL
Fixed dose combination tablet containing DOR/ISL 100 mg/0.25 mg taken by mouth.

Treatment: Drugs: BIC/FTC/TAF
Fixed dose combination tablet containing BIC/FTC/TAF 50 mg/200 mg/25 mg taken by mouth.

Treatment: Drugs: Placebo to DOR/ISL
Placebo tablet matched to DOR/ISL tablet taken by mouth.

Treatment: Drugs: Placebo to BIC/FTC/TAF
Placebo tablet matched to BIC/FTC/TAF tablet taken by mouth.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Percentage of participants with human immunodeficiency virus type 1 (HIV-1) ribonucleic acid (RNA) <50 copies/mL at Week 48
Timepoint [1] 0 0
Week 48
Primary outcome [2] 0 0
Percentage of participants experiencing =1 adverse event (AE) through Week 48
Timepoint [2] 0 0
Up to 48 weeks
Primary outcome [3] 0 0
Percentage of participants discontinuing from study treatment due to an AE through Week 48
Timepoint [3] 0 0
Up to 48 weeks
Secondary outcome [1] 0 0
Percentage of participants with HIV-1 RNA <50 copies/mL at Week 96
Timepoint [1] 0 0
Week 96
Secondary outcome [2] 0 0
Percentage of participants with HIV-1 RNA <200 copies/mL at Week 48
Timepoint [2] 0 0
Week 48
Secondary outcome [3] 0 0
Percentage of participants with HIV-1 RNA <200 copies/mL at Week 96
Timepoint [3] 0 0
Week 96
Secondary outcome [4] 0 0
Change from baseline in cluster of differentiation 4+ (CD4+) T-cells at Week 48
Timepoint [4] 0 0
Baseline (Day 1) and Week 48
Secondary outcome [5] 0 0
Change from baseline in CD4+ T-cells at Week 96
Timepoint [5] 0 0
Baseline (Day 1) and Week 96
Secondary outcome [6] 0 0
Incidence of viral drug resistance
Timepoint [6] 0 0
Up to 96 weeks
Secondary outcome [7] 0 0
Change from baseline in body weight at Week 48
Timepoint [7] 0 0
Baseline (Day 1) and Week 48
Secondary outcome [8] 0 0
Change from baseline in body weight at Week 96
Timepoint [8] 0 0
Baseline (Day 1) and Week 96
Secondary outcome [9] 0 0
Percentage of participants experiencing =1 AE through Week 96
Timepoint [9] 0 0
Up to 96 weeks
Secondary outcome [10] 0 0
Percentage of participants discontinuing from study treatment due to an AE through Week 96
Timepoint [10] 0 0
Up to 96 weeks

Eligibility
Key inclusion criteria
* Is HIV-1 positive with plasma HIV-1 RNA =500 copies/mL at screening
* Is naïve to antiretroviral therapy (ART) defined as having received no prior therapy with any antiretroviral agent following a diagnosis of HIV-1 infection
* If female, is not a participant of childbearing potential (POCBP); or if a POCBP, is not pregnant or breastfeeding, and is willing to use an acceptable contraceptive method or abstain from heterosexual intercourse for study duration
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
* Has HIV-2 infection
* Has hypersensitivity or other contraindication to any of the components of the study interventions as determined by the investigator
* Has a diagnosis of an active AIDS-defining opportunistic infection within 30 days prior to screening
* Has active hepatitis B infection (defined as hepatitis B surface antigen [HBsAg]-positive or HBV deoxyribonucleic acid [DNA]-positive).
* Has chronic hepatitis C virus (HCV) infection (detectable HCV ribonucleic acid [RNA]) and lab values are consistent with cirrhosis
* 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 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, such that it is not in the best interest of the participant to participate

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
8/03/2023
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/11/2026
Actual
Sample size
Target
500
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
United States of America
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Arizona
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United States of America
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California
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District of Columbia
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United States of America
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Florida
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United States of America
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Georgia
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United States of America
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Illinois
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Michigan
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Missouri
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Nevada
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New Jersey
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New York
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North Carolina
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Ohio
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United States of America
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Texas
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Argentina
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Buenos Aires
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Argentina
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Santa Fe
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Argentina
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Cordoba
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Canada
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Quebec
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Chile
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Araucania
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Chile
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Maule
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Chile
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Region M. De Santiago
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Colombia
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Atlantico
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Colombia
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Distrito Capital De Bogota
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Colombia
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Valle Del Cauca
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Dominican Republic
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Santo Domingo
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France
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Alpes-Maritimes
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France
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Ile-de-France
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France
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Nord
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France
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Paris
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Germany
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Baden-Wurttemberg
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Germany
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Bayern
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Germany
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Nordrhein-Westfalen
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Germany
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Hamburg
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Guatemala
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Guatemala
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Israel
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Haifa
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Israel
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Jerusalem
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Israel
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Ramat Gan
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Israel
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Tel Aviv
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Japan
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Aichi
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Japan
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Tokyo
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Japan
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Osaka
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Malaysia
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Kedah
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Malaysia
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Kuala Lumpur
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Malaysia
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Pulau Pinang
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Malaysia
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Sarawak
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Malaysia
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Selangor
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Puerto Rico
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Ponce
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Puerto Rico
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San Juan
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South Africa
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Free State
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South Africa
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Gauteng
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South Africa
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Kwazulu-Natal
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South Africa
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North-West
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South Africa
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Western Cape
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Spain
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Alicante
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Spain
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Barcelona
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Spain
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Cataluna
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Spain
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Madrid, Comunidad De
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Spain
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Madrid
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Spain
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Malaga
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Switzerland
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Basel-Stadt
Country [61] 0 0
Switzerland
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Geneve
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Thailand
State/province [62] 0 0
Krung Thep Maha Nakhon
Country [63] 0 0
Thailand
State/province [63] 0 0
Chiang Mai
Country [64] 0 0
Turkey
State/province [64] 0 0
Ankara
Country [65] 0 0
United Kingdom
State/province [65] 0 0
Bristol, City Of
Country [66] 0 0
United Kingdom
State/province [66] 0 0
England
Country [67] 0 0
United Kingdom
State/province [67] 0 0
London, City Of

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Merck Sharp & Dohme LLC
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
This is a randomized, active-controlled, double-blind clinical study designed to evaluate the antiretroviral activity, safety, and tolerability of doravirine/islatravir (DOR/ISL \[MK-8591A\]) in treatment-naïve participants with human immunodeficiency virus type 1 (HIV-1) infection. It is hypothesized that DOR/ISL is non-inferior to bictegravir/emtricitabine/tenofovir alafenamide (BIC/FTC/TAF) as assessed by the percentage of participants with HIV-1 ribonucleic acid (RNA) \<50 copies/mL at Week 48.
Trial website
https://clinicaltrials.gov/study/NCT05705349
Trial related presentations / publications
Public notes
This record is viewable in the ANZCTR as it had previously listed Australia and/or New Zealand as a recruitment site, however these sites have since been removed

Contacts
Principal investigator
Name 0 0
Medical Director
Address 0 0
Merck Sharp & Dohme LLC
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Toll Free Number
Address 0 0
Country 0 0
Phone 0 0
1-888-577-8839
Fax 0 0
Email 0 0
Trialsites@merck.com
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT05705349