HIV-1-infection
Conditions
Keywords
rapid start, rapid art initiation, bictegravir, hispanic, latinx, latinos, advanced HIV, AIDS
Brief summary
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
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.
Interventions
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.
Sponsors
Gilead Sciences
Valley AIDS Council
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 99 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Viral Suppression | 24 weeks | To evaluate efficacy and time to HIV viral suppression of Biktarvy in Rapid Start setting for persons with Advanced HIV |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Viral Suppression | 48 weeks | To evaluate efficacy, continued viral suppression of Biktarvy through 48 weeks. |
| CD4 cell recovery | 48 weeks | Secondary objectives would be to evaluate immune function recovery via absolute CD4 cell count |
Other
| Measure | Time frame | Description |
|---|---|---|
| post-hoc analyses to evaluate potential associations of baseline characteristics on viral suppression | 48-72 weeks | Descriptive analysis will evaluate potential associations of baseline characteristics on primary endpoint outcomes/ HIV viral suppression: sex at birth |
| Post-hoc analyses to evaluate potential associations of baseline characteristics on viral suppression | 48-72 weeks | Descriptive analysis will evaluate potential associations of baseline characteristics on primary endpoint outcomes/ HIV viral suppression: initial HIV viral load |
| Post-hoc analyses to evaluate potential associations of baseline characteristics on viral | 48-72 weeks | Descriptive analysis will evaluate potential associations of baseline characteristics on primary endpoint outcomes/ HIV viral suppression: patient reported treatment adherence |
Contacts
Primary ContactDora A Martinez, MD
Backup ContactJaime Rebeles, LVN
Outcome results
None listed