Status:
COMPLETED
Clinical Opportunities and Management to Exploit Biktarvy as Asynchronous Connection Key (COMEBACK)
Lead Sponsor:
Gregory Huhn
Collaborating Sponsors:
Gilead Sciences
Conditions:
Hiv
Eligibility:
All Genders
18+ years
Phase:
NA
Brief 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 p...
Detailed Description
In most settings in the US when patients out of care and off of ART reengage with clinical providers routine labs are collected, including CMP, CD4, VL, and HIV resistance testing when indicated, heal...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 3 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 6 2024
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT04519970
Start Date
September 3 2020
End Date
April 6 2024
Last Update
March 25 2025
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Ruth M. Rothstein CORE Center
Chicago, Illinois, United States, 60612