Advanced HIV: Outcomes for Rapid ART
AHORA
1 other identifier
observational
50
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Aug 2022
Typical duration for all trials
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 25, 2022
CompletedStudy Start
First participant enrolled
August 30, 2022
CompletedFirst Posted
Study publicly available on registry
September 2, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 30, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
January 15, 2025
CompletedSeptember 2, 2022
August 1, 2022
2 years
July 25, 2022
August 30, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (4)
Viral Suppression
48 weeks
CD4 cell recovery
48 weeks
CD4 cell recovery
48 weeks
CD4 cell recovery
48 weeks
Other Outcomes (8)
post-hoc analyses to evaluate potential associations of baseline characteristics on viral suppression
48-72 weeks
post-hoc analyses to evaluate potential associations of baseline characteristics on viral suppression
48-72 weeks
post-hoc analyses to evaluate potential associations of baseline characteristics on viral suppression
48-72 weeks
- +5 more other outcomes
Study Arms (1)
AHORA group
All 50 prospective subjects are enrolled into a single cohort, all subjects must meet inclusion/exclusion criteria
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.
Eligibility Criteria
Patients with advanced HIV in the Rio Grande Valley (RGV) of Texas who are receiving treatment services with Valley AIDS Council (VAC) dba Westbrook Clinic (WBC). 92% of patients receiving services at VAC/WBC identify as Hispanic/Latinx.
You may qualify if:
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Valley AIDS Councillead
- Gilead Sciencescollaborator
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 25, 2022
First Posted
September 2, 2022
Study Start
August 30, 2022
Primary Completion
August 30, 2024
Study Completion
January 15, 2025
Last Updated
September 2, 2022
Record last verified: 2022-08
Data Sharing
- IPD Sharing
- Will not share
Coded data will be kept by sponsor for potential future use if patient subject consents to their data being used for future research. Presently there is no plan to share IPD. However, data obtained through this study may be provided to qualified researchers with academic interest in HIV. Data shared will be coded, with no PHI included. Approval of the request and execution of all applicable agreements (i.e. a material transfer agreement) are prerequisites to the sharing of data with the requesting party. Data requests can be submitted starting 9 months after article publication and the data will be made accessible for up to 24 months. Extensions will be considered on a case-by-case basis. Access to trial IPD can be requested by qualified researchers engaging in independent scientific research, and will be provided following review and approval of a research proposal and Statistical Analysis Plan (SAP) and execution of a Data Sharing Agreement (DSA).