Clinical Opportunities and Management to Exploit Biktarvy as Asynchronous Connection Key (COMEBACK)

Completed · Not applicable

Conditions studied: Hiv

In brief

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.

Key facts

Study ID

NCT04519970

Run by

Gregory Huhn

People needed

100

Starts

2020-09-03

Expected to finish

2024-04-06

Last updated by the study team

2025-03-25

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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
• Concomitant use of medications that are contraindicated with bictegravir, emtricitabine and tenofovir alafenamide including adefovir, carbamazepine, cladribine, dofetilide, fosphenytoin-phenytoin, oxcarbazepine, phenobarbital, primidone, rifampin, rifabutin, rifapentine, St. John's Wort, tipranavir

Where it is running

• Ruth M. Rothstein CORE Center — Chicago, Illinois, United States

Full record on ClinicalTrials.gov

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