Advanced HIV: Outcomes for Rapid ART
NCT05526118 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 50
Last updated 2022-09-02
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.
Conditions
Interventions
- DRUG
-
Bictegravir/emtricitabine/tenofovir alafenamide
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 & Collaborators
- collaborator INDUSTRY
-
Valley AIDS Council
lead OTHER
Eligibility
- Min Age
- 18 Years
- Max Age
- 99 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2022-08-30
- Primary Completion
- 2024-08-30
- Completion
- 2025-01-15
- FDA Drug
- Yes
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