NCT04519970Completed
Clinical Opportunities and Management to Exploit Biktarvy as Asynchronous Connection Key (COMEBACK)
(COMEBACK): Biktarvy in PLWH But Not Retained in Care Coupled With a Strengths-based Case Management Approach to Assess Virologic Suppression Rates and Retention in Care, Along With Patient Reported Outcomes (PROS).
Source: ClinicalTrials.gov · Last updated 25 Mar 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 100 (actual)
- First submitted
- 10 Aug 2020
- Start date
- 3 Sept 2020
- Primary completion date
- 6 Oct 2023
- Lead sponsor
- Gregory Huhn
- Diseases
- HIV
- NCT number
- NCT04519970
What you commit to
- Study type: Interventional
- Participants enrolled: 100
- From 3 Sept 2020 to the primary completion date, 6 Oct 2023
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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
- 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
Other illness
- 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.
- 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
Other
- Pregnancy
- Unable or unwilling to provide consent for study participation
- Current participation in another ART adherence study
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Ruth M. Rothstein CORE Center Coordinator of this site? Confirm its status | Chicago | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.