Advanced HIV: Outcomes for Rapid ART

Study Overview
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Brief Summary
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AHORA is designed as a single-arm, open label, non-comparative, real-world prospective, observational study evaluating the outcomes for viral control and CD4 recovery/immune reconstitution in predominantly Hispanic/Latinx patients of the Rio Grande Valley (RGV) with advanced HIV who are rapidly initiated on bictegravir/emtricitabine/tenofovir alafenamide (Biktarvy) at Valley AIDS Council (VAC) dba Westbrook Clinic (WBC). This research will help to fill data gaps still present for Biktarvy in a rapid start setting among an Hispanic/Latinx population, including those with advanced HIV.

Detailed Description
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VAC is the primary provider of HIV prevention, education and testing services and the only Ryan White funded agency providing medical care and supportive services for people with HIV in the RGV. VAC provides services to over 1700 patients with HIV, 52% of patients at VAC are diagnosed with advanced HIV disease. Generally speaking, HIV clinical trials have often lacked representation and enrollment of patients of Hispanic/Latinx ethnicity, and those with advanced HIV and this study has the potential to fill in those data gaps. For AHORA, data from ART-naive, newly diagnosed HIV-1+ adults (18 years of age and older) with late presentation (CD4<200 or diagnosed Opportunistic infection/AIDS-defining illness) initiated on Biktarvy within 7 days from diagnosis will be collected and analyzed. Patients will be enrolled through VAC's linkage to care and RAPIDO (Rapid Start) programs. Patients appropriate for Rapid ART initiation with Biktarvy will be recruited, with a goal of 50 enrollees. Patients who agree to participate will have data collected at weeks 1,4,12, 24, 36, and 48 weeks for evaluation of time to viral suppression and efficacy, as well as evaluation of CD4 cell recovery.

Official Title
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Advanced HIV: Outcomes for Rapid ART

Conditions
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HIV-1-infection

Intervention / Treatment
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* Drug: Bictegravir/emtricitabine/tenofovir alafenamide


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: ART-naive adults,18 years of age and older diagnosed with HIV within 7 days of study entry diagnosis of Advanced HIV: clinical (diagnosed Opportunistic Infection/AIDS-defining illness) or laboratory (CD4<200) diagnosis of advanced HIV. Exclusion Criteria: Known severe renal impairment (CrCl <30 mL/min/1.73 m2); Known or suspected severe hepatic impairment or unstable liver disease (Child Pugh Class C); Use of rifamycins for treatment of OIs use of concomitant medications that would be contraindicated for coadministration with Biktarvy; OI diagnosis requiring initiation of OI treatment for >7 days prior to initiation of ART. pregnant at time of diagnosis

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 99 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| AHORA group<br>All 50 prospective subjects are enrolled into a single cohort, all subjects must meet inclusion/exclusion criteria | Drug: Bictegravir/emtricitabine/tenofovir alafenamide<br>* Patients who are ART-naive adults,18 years of age and older, diagnosed with HIV within 7 days of study entry who have a clinical (diagnosed Opportunistic Infection/AIDS-defining illness) or laboratory (CD4<200) diagnosis of advanced HIV, who are clinically appropriate for Rapid ART initiation, and are initiated on bic/f/taf per DHHS guidelines at their initial clinic visit will be monitored for time to viral suppression, efficacy and CD4 cell recovery over the course of 48 weeks.<br>* Other names: Biktarvy;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Viral Suppression | To evaluate efficacy and time to HIV viral suppression of Biktarvy in Rapid Start setting for persons with Advanced HIV | 24 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Viral Suppression | To evaluate efficacy, continued viral suppression of Biktarvy through 48 weeks. | 48 weeks | 
| CD4 cell recovery | Secondary objectives would be to evaluate immune function recovery via absolute CD4 cell count | 48 weeks | 
| CD4 cell recovery | Secondary objectives would be to evaluate immune function recovery via percent CD4 cell count | 48 weeks | 
| CD4 cell recovery | Secondary objectives would be to evaluate immune function recovery via CD4/CD8 ratio | 48 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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rapid start, rapid art initiation, bictegravir, hispanic, latinx, latinos, advanced HIV, AIDS