Advanced HIV: Outcomes for Rapid ART (AHORA)

Valley AIDS Council

Status

Not yet enrolling

Conditions

HIV-1-infection

Treatments

Drug: Bictegravir/emtricitabine/tenofovir alafenamide

Study type

Observational

Funder types

Other

Industry

Identifiers

NCT05526118

VAC-AHORA-1

Details and patient eligibility

About

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.

Full 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.

Enrollment

50 estimated patients

Sex

All

Ages

18 to 99 years old

Volunteers

No Healthy Volunteers

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