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 range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
. 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