Efficacy of Doravirine + Dolutegravir Dual Therapy in the Context of Antiretroviral Therapy Switch
NCT ID: NCT04892654
Last Updated: 2023-10-25
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE3
150 participants
INTERVENTIONAL
2022-08-17
2027-11-30
Brief Summary
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For this reason researchers are interested in looking at alternative therapies that might expose patients to fewer and less severe side effects while providing the same quality of care as antiretroviral therapies most often used to treat HIV.
The purpose of this study is to investigate if the study drug combination that is being tested (doravirine + dolutegravir) is safe compared with other triple cART regimens.
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Detailed Description
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A computer-based software will randomise participants 2:1 to either the (1) experimental arm (early switch group) to take two-pill regimen for 96 weeks, or (2) control arm (delayed switch group) where participants continue their current triple cART regimen for 48 weeks, then switch to the two-pill regimen for another 48 weeks.
Viral load will be measured at each study visit to determine the percentage of participants in each treatment arm with undetectable plasma HIV RNA levels at week 48.
Additional research urine and bloods will be taken, as well as questionnaires completed at baseline and every 24 weeks to further investigate safety, tolerability, and quality of life from switch of suppressive triple cART to doravirine + dolutegravir dual cART.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Immediate Switch
Two-pill regimen, doravirine (100 mg) + dolutegravir (50 mg) tablets taken orally once daily for 96 weeks.
Doravirine
Antiretroviral, Non-nucleoside Reverse Transcriptase Inhibitor
Dolutegravir
Antiretroviral, Integrase strand transfer inhibitors
Delayed Switch
Participants will continue their current triple cART regimen for 48 weeks. Patients will then be switched to two-pill regimen, doravirine (100 mg) + dolutegravir (50 mg) tablets taken orally once daily for 48 weeks.
Doravirine
Antiretroviral, Non-nucleoside Reverse Transcriptase Inhibitor
Dolutegravir
Antiretroviral, Integrase strand transfer inhibitors
Triple cART regimen
Participant standard triple cART regimen
Interventions
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Doravirine
Antiretroviral, Non-nucleoside Reverse Transcriptase Inhibitor
Dolutegravir
Antiretroviral, Integrase strand transfer inhibitors
Triple cART regimen
Participant standard triple cART regimen
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* On stable \& suppressive triple cART for at least 6 months
* No evidence of resistance to DOR or DTG
* No laboratory abnormalities, medical/psychiatric conditions or alcohol/drug use considered a barrier to participation by investigators
* Women who are pre-menopausal and sexually active should be on one of the following methods of contraception:
* Implant
* Depot injection
* Intra-uterine device or system
* Oral hormonal contraception
Exclusion Criteria
* History of virological failure on an INSTI in absence of a post-failure genotypic resistance test proving absence of resistance to DTG (INSTI mutations that will lead to the need of administering DTG twice-daily are considered as resistance to DTG - and the subject will be considered NOT eligible)
* Concomitant medication contra-indicated with DTG or DOR
* Haemoglobin \<9 g/dL
* Platelets \<80,000/mm3
* Creatinine clearance \<30 mL/min
* AST or ALT ≥5N
* Acute Hepatitis A infection.
* Concomitant DAA for anti-HCV therapy
* Known acute or chronic viral hepatitis B or C.
* Individuals testing positive for HBcAb, but negative HBsAg/HBeAg, may be included on the trial.
* Individuals with positive anti-HCV results, but with HCV RNA not detected may be included on the trial.
* Pregnant or breastfeeding women
18 Years
ALL
No
Sponsors
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Chelsea and Westminster NHS Foundation Trust
OTHER
Responsible Party
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Principal Investigators
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Marta Boffito, MD PhD FRCP
Role: PRINCIPAL_INVESTIGATOR
Chelsea and Westminster NHS Foundation Trust
Locations
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Mortimer Market Centre
London, , United Kingdom
Chelsea & Westminster Hospital NHS Foundation Trust
London, , United Kingdom
Imperial College Healthcare NHS Trust
London, , United Kingdom
Countries
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Central Contacts
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Facility Contacts
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Role: backup
Other Identifiers
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2020-003928-17
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
CW004
Identifier Type: -
Identifier Source: org_study_id
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