HivCOMEBACKNCT04519970
Clinical Opportunities and Management to Exploit Biktarvy as Asynchronous Connection Key (COMEBACK)
A study testing Case Management in people with Hiv, run by Gregory Huhn at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Hiv
- What is being tested?
- Case Management
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Sep 2020to 6 Apr 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Ruth M. Rothstein CORE Center
Chicago, Illinois, 60612
About this study
Official title: (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).
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.
Read the 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, healthcare benefits are reassessed, and the most recent ART regimen is restarted if the patient agrees to treatment. There may be characteristics of these regimens that may present barriers to sufficient adherence, or perform suboptimally in patients with certain immunologic and/or viral factors, which may impact virologic suppression, including multiple pills, drug-drug interactions, variable tolerability, low CD4, high VL, or low thresholds for resistance. Biktarvy is a Single Tablet Regimen (STR) with high potency and good tolerability that can be safely used in multiple patient groups, with features, including activity in patients with a history of multi-class resistance, that may facilitate immediate ART reinitiation among a broad population of patients reengaging in care in order to promote rapid virologic suppression. Addressing this important patient population with poor retention with support mechanisms to reengage in care and reinitiate effective ART immediately may improve retention in care and accelerate virologic suppression as likewise derived in immediate ART models in treatment-naïve patients, and represent a touchstone to drive sustainability in preventing new HIV transmissions in a high burden area to meet the goals of reducing HIV as a public health threat over the next 10 years.
- Conditions
- Hiv
- Being tested
- Case Management
- Keywords
- Adherence, Case Management, Biktarvy
- Medical subject headings
- Acquired Immunodeficiency Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Case ManagementBehavioural
Each tier will have a different level of case management and support, all with the goal of increasing adherence to Biktarvy for HIV management.
| Study group | Role | What they receive |
|---|---|---|
| Highest Tier of Case Management (Piggyback) and Biktarvy | Active comparator | The most intensive tier of case management. Includes three appointment reminders; check ins twice per week; travel compensation; housing support; food insecurity support; follow ups for missed appointments and off pill counts; connections with substance use programs; meetings with the benefits department for health insurance needs; childcare support to make appointments; mental healthcare referrals; open pool appointments as back-up options in case of rescheduling needs; late doctor's appointments and prescription pick up for those working during the day; meetings with the health educators to discuss HIV and ART; and re-motivation of HIV treatment every 3 months. Receives: Behavioral: Case Management |
| Middle Tier of Case Management (Got Your Back) and Biktarvy | Active comparator | The middle tier (Got Your Back) will work closely with the CORE case managers to augment their work in housing support, transportation assistance, mental healthcare referrals, childcare assistance, substance use program referrals, food insecurity support and health insurance needs. The retention specialist will additionally provide this middle tier 2 reminders for appointments; check ins once per week; follow ups for missed appointments or off pill counts; support with scheduling appointments for limited availability; meetings with the health educators for information on HIV or ART; and re-motivation for treatment at the 6 and 9 month marks of participation. Receives: Behavioral: Case Management |
| Lowest Tier of Case Management (Backbone) and Biktarvy | Active comparator | The top tier (Backbone) will need the least amount of support and also have a CORE Center case manager for a majority of the support in housing, food, insurance, transportation, childcare, substance use, and mental healthcare. The retention specialist will still provide an appointment reminder; check ins every other week; text checkups after missed appointments or off pill counts; support with scheduling for appointments or prescription pick up for limited availability; and re-motivation of treatment for HIV at the 9 month mark of study participation. Receives: Behavioral: Case Management |
What is being measured
The primary outcome is the main question the study is designed to answer.
Virologic Suppression Rates
Number of patients with virologic suppression, defined as HIV RNA <200 copies/ml at week 48 RNA.
Measured: 1 year
Retention in Care
Number of patients retained in study, defined as at least 2 visits or 2 HIV-1 RNA viral load reports occurring at least 3 months apart within the 12-month study time period
Measured: 1 year
Secondary outcomes (1)
Patient Reported Outcomes concerning social and health related barriers
Favorable outcomes concerning health and and social related determinants as assessed by responses to a series of Patient Reported Outcomes at 6 and 12 months. See full list in attached documents.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2020
- Study start3 Sep 2020
- Primary completion6 Oct 2023
- Study completion6 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HivStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gregory Huhn
- Sponsor type
- University, hospital or other
- Collaborators
- Gilead Sciences
- Responsible party
- Sponsor-investigator, Gregory Huhn, Ruth M. Rothstein CORE Center
- Investigators
- Gregory Huhn, MD, MPHTM, Principal investigator, Ruth M. Rothstein CORE Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04519970
- Sponsor's protocol ID
- IN-US-380-5725
- Acronym
- COMEBACK
- Status last verified
- Aug 2024
- First submitted
- 10 Aug 2020
- Last updated
- 25 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- (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).
- ClinicalTrials.gov ID
- NCT04519970
- Acronym / sponsor ID
- COMEBACK / IN-US-380-5725
- Conditions
- Hiv
- Keywords
- Adherence, Case Management, Biktarvy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Gregory HuhnUniversity, hospital or other
- Collaborators
- Gilead Sciences
- Study start
- 3 Sep 2020 (actual)
- Primary completion
- 6 Oct 2023 (actual)
- Study completion
- 6 Apr 2024 (actual)
- First posted
- 20 Aug 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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, healthcare benefits are reassessed, and the most recent ART regimen is restarted if the patient agrees to treatment. There may be characteristics of these regimens that may present barriers to sufficient adherence, or perform suboptimally in patients with certain immunologic and/or viral factors, which may impact virologic suppression, including multiple pills, drug-drug interactions, variable tolerability, low CD4, high VL, or low thresholds for resistance. Biktarvy is a Single Tablet Regimen (STR) with high potency and good tolerability that can be safely used in multiple patient groups, with features, including activity in patients with a history of multi-class resistance, that may facilitate immediate ART reinitiation among a broad population of patients reengaging in care in order to promote rapid virologic suppression. Addressing this important patient population with poor retention with support mechanisms to reengage in care and reinitiate effective ART immediately may improve retention in care and accelerate virologic suppression as likewise derived in immediate ART models in treatment-naïve patients, and represent a touchstone to drive sustainability in preventing new HIV transmissions in a high burden area to meet the goals of reducing HIV as a public health threat over the next 10 years.
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Highest Tier of Case Management (Piggyback) and Biktarvy | Active comparator | Behavioral: Case ManagementThe most intensive tier of case management. Includes three appointment reminders; check ins twice per week; travel compensation; housing support; food insecurity support; follow ups for missed appointments and off pill counts; connections with substance use programs; meetings with the benefits department for health insurance needs; childcare support to make appointments; mental healthcare referrals; open pool appointments as back-up options in case of rescheduling needs; late doctor's appointments and prescription pick up for those working during the day; meetings with the health educators to discuss HIV and ART; and re-motivation of HIV treatment every 3 months. |
| Middle Tier of Case Management (Got Your Back) and Biktarvy | Active comparator | Behavioral: Case ManagementThe middle tier (Got Your Back) will work closely with the CORE case managers to augment their work in housing support, transportation assistance, mental healthcare referrals, childcare assistance, substance use program referrals, food insecurity support and health insurance needs. The retention specialist will additionally provide this middle tier 2 reminders for appointments; check ins once per week; follow ups for missed appointments or off pill counts; support with scheduling appointments for limited availability; meetings with the health educators for information on HIV or ART; and re-motivation for treatment at the 6 and 9 month marks of participation. |
| Lowest Tier of Case Management (Backbone) and Biktarvy | Active comparator | Behavioral: Case ManagementThe top tier (Backbone) will need the least amount of support and also have a CORE Center case manager for a majority of the support in housing, food, insurance, transportation, childcare, substance use, and mental healthcare. The retention specialist will still provide an appointment reminder; check ins every other week; text checkups after missed appointments or off pill counts; support with scheduling for appointments or prescription pick up for limited availability; and re-motivation of treatment for HIV at the 9 month mark of study participation. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Case ManagementEach tier will have a different level of case management and support, all with the goal of increasing adherence to Biktarvy for HIV management. | Behavioural | Highest Tier of Case Management (Piggyback) and Biktarvy, Lowest Tier of Case Management (Backbone) and Biktarvy, Middle Tier of Case Management (Got Your Back) and Biktarvy |
Primary outcome
Virologic Suppression Rates
Time frame: 1 year
Number of patients with virologic suppression, defined as HIV RNA <200 copies/ml at week 48 RNA.
Retention in Care
Time frame: 1 year
Number of patients retained in study, defined as at least 2 visits or 2 HIV-1 RNA viral load reports occurring at least 3 months apart within the 12-month study time period
1 secondary outcome
Patient Reported Outcomes concerning social and health related barriers
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Mar 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gregory Huhn, MD, MPHTM principal investigator
Ruth M. Rothstein CORE Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Case Management in people with Hiv, run by Gregory Huhn at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Virologic Suppression Rates (time frame: 1 year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Mar 2025.