Bictegravir/Emtricitabine/Tenofovir Alafenide Plus Doravirine
NCT ID: NCT04538040
Last Updated: 2024-03-05
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE4
20 participants
INTERVENTIONAL
2019-12-19
2021-11-11
Brief Summary
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Hypothesis:
Patients with prior NUC or NNRTI resistance (but not to rilpivirine or doravirine) will maintain their virologic suppression after a drug regimen switch from rilpivirine/emtricitabine/tenofovir alafenamide in combination with dolutegravir, to bictegravir/emtricitabine/tenofovir alafenamide in combination with doravirine. The switch therapy will avoid food interactions, and will be well tolerated by subjects.
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Biktarvy + Doravirine Switch
bictegravir 50mg/emtricitabine 200mg/tenofovir alafenamide 25mg tablets + doravirine 100mg tablets taken orally once per day
Bictegravir/emtricitabine/tenofovir alafenamide + Doravirine switch
Safety and efficacy of switching from rilpivirine/emtricitabine/tenofovir alafenamide in combination with dolutegravir, to bictegravir/emtricitabine/tenofovir alafenamide in combination with doravirine in male, 45+ year old subjects. The study will also include secondary outcomes of quality of life (QOL) and weight changes.
Interventions
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Bictegravir/emtricitabine/tenofovir alafenamide + Doravirine switch
Safety and efficacy of switching from rilpivirine/emtricitabine/tenofovir alafenamide in combination with dolutegravir, to bictegravir/emtricitabine/tenofovir alafenamide in combination with doravirine in male, 45+ year old subjects. The study will also include secondary outcomes of quality of life (QOL) and weight changes.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Any genotypic or phenotypic resistance except k65R, 69 insertion, integrase resistance, or resistance to rilpivarine or doravirine.
* Receiving combination antiretroviral regimen of rilpivirine/emtricitabine/tenofovir alafenamide in combination with dolutegravir \> 12 months and with viral load \<50 copies/ mL on at least one occasion within the six months prior to switch.
* Suppressed viral load as defined by one plasma HIV RNA level \< 50 copies/mL within previous 6 months.
* Capable of providing informed consent
Exclusion Criteria
* Nucleoside reverse transcriptase (NRTI) mutation 69 insertion or k65R mutation
* Documented second generation non-nucleoside reverse transcriptase inhibitor (NNRTI) resistance (rilpivirine or doravirine)
45 Years
MALE
No
Sponsors
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Gilead Sciences
INDUSTRY
Quest Clinical Research
OTHER
Responsible Party
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Locations
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SFOMG Private Practice
San Francisco, California, United States
Countries
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Document Type: Informed Consent Form
Other Identifiers
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BETD-001
Identifier Type: -
Identifier Source: org_study_id
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