Clinical Opportunities and Management to Exploit Biktarvy as Asynchronous Connection Key (COMEBACK) (NCT04519970) | Clinical Trial Compass
CompletedNot Applicable
Clinical Opportunities and Management to Exploit Biktarvy as Asynchronous Connection Key (COMEBACK)
United States100 participantsStarted 2020-09-03
Plain-language summary
COMEBACK is an investigator-initiated, 48-week study. The study will be conducted in 100 persons living with HIV (PLWH) who have been off ART for two or more weeks. All enrolled participants will be prescribed Biktarvy, if determined appropriate upon review of past historical resistance tests, for use throughout the study period. Participants will also complete a series of Patient Reported Outcomes (PROs) at screening and be assigned one of three tiers of case management intervention (Piggyback, Got Your Back, Backbone), with each tier increasing in intensity regarding intervention techniques and options provided. Participants will be assessed for virologic suppression, retention in care, and PROS throughout study follow up and at study end.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. HIV-infected
✓. Not on ART for \>2 weeks
✓. History of estimated eGFR \> 30 ml3/min
✓. Baseline labs (CBC, CMP, CD4+, HIV-1 RNA) and resistance genotype test collected \<2 weeks or on day of Biktarvy ART reinitiation
✓. 18 years or older
Exclusion criteria
✕. No history of primary integrase inhibitor mutations, \>3 TAMs, K70E, Q151M, T69 insertion, or K65R + M184V/I on prior resistance testing
✕. Drug-drug interactions with Biktarvy
✕. Pregnancy
✕. Unable or unwilling to provide consent for study participation
✕. Any condition that, in the opinion of the Investigator of Record (IoR), would make participation in the study unsafe, complicate interpretation of outcome data, or otherwise interfere with achieving the study objective.
✕. Current participation in another ART adherence study
✕. Allergy to bictegravir, emtricitabine or tenofovir alafenamide
✕. Signs or symptoms of opportunistic infection with cryptococcal meningitis, tuberculosis or other infection that requires delay of reinitiation of antiretroviral therapy