Advanced HIV: Outcomes for Rapid ART

NCT05526118 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 50

Last updated 2022-09-02

No results posted yet for this study

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

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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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05526118 on ClinicalTrials.gov