Advanced HIV: Outcomes for Rapid ART (AHORA)

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.

Study Overview

• Status: Not yet recruiting
• Conditions: HIV-1-infection
• Intervention / Treatment: Drug: Bictegravir/emtricitabine/tenofovir alafenamide

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.

• Study Type: Observational
• Enrollment (Anticipated): 50

Contacts and Locations

• Study Contact: Name: Dora A Martinez, MD; Phone Number: 956-428-2653; Email: dmartinez@westbrookclinic.org
• Study Contact Backup: Name: Jaime Rebeles, LVN; Phone Number: 956-367-3031; Email: jrebeles@westbrookclinic.org

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 99 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

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.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

AHORA group; All 50 prospective subjects are enrolled into a single cohort, all subjects must meet inclusion/exclusion criteria

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.; Other Names: Biktarvy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Viral Suppression	To evaluate efficacy, continued viral suppression of Biktarvy through 48 weeks.	48 weeks
CD4 cell recovery	Secondary objectives would be to evaluate immune function recovery via absolute CD4 cell count	48 weeks
CD4 cell recovery	Secondary objectives would be to evaluate immune function recovery via percent CD4 cell count	48 weeks
CD4 cell recovery	Secondary objectives would be to evaluate immune function recovery via CD4/CD8 ratio	48 weeks

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
post-hoc analyses to evaluate potential associations of baseline characteristics on viral suppression	Descriptive analysis will evaluate potential associations of baseline characteristics on primary endpoint outcomes/ HIV viral suppression: sex at birth	48-72 weeks
post-hoc analyses to evaluate potential associations of baseline characteristics on viral suppression	Descriptive analysis will evaluate potential associations of baseline characteristics on primary endpoint outcomes/ HIV viral suppression: age at HIV diagnosis	48-72 weeks
post-hoc analyses to evaluate potential associations of baseline characteristics on viral suppression	Descriptive analysis will evaluate potential associations of baseline characteristics on primary endpoint outcomes/ HIV viral suppression: CD4 nadir	48-72 weeks
Post-hoc analyses to evaluate potential associations of baseline characteristics on viral suppression	Descriptive analysis will evaluate potential associations of baseline characteristics on primary endpoint outcomes/ HIV viral suppression: initial HIV viral load	48-72 weeks
Post-hoc analyses to evaluate potential associations of baseline characteristics on viral	Descriptive analysis will evaluate potential associations of baseline characteristics on primary endpoint outcomes/ HIV viral suppression: patient reported treatment adherence	48-72 weeks
Post-hoc analyses to evaluate potential associations of baseline characteristics on viral	Descriptive analysis will evaluate potential associations of baseline characteristics on primary endpoint outcomes/ HIV viral suppression: medical insurance status	48-72 weeks
Post-hoc analyses to evaluate potential associations of baseline characteristics on viral	Descriptive analysis will evaluate potential associations of baseline characteristics on primary endpoint outcomes/ HIV viral suppression: housing status	48-72 weeks
Post-hoc analyses to evaluate potential associations of baseline characteristics on viral	Descriptive analysis will evaluate potential associations of baseline characteristics on primary endpoint outcomes/ HIV viral suppression: federal poverty level	48-72 weeks

Collaborators and Investigators

• Sponsor: Valley AIDS Council
• Collaborators: Gilead Sciences

Study record dates

Study Major Dates

• Study Start (Anticipated): August 30, 2022
• Primary Completion (Anticipated): August 30, 2024
• Study Completion (Anticipated): January 15, 2025

Study Registration Dates

• First Submitted: July 25, 2022
• First Submitted That Met QC Criteria: August 30, 2022
• First Posted (Actual): September 2, 2022

Study Record Updates

• Last Update Posted (Actual): September 2, 2022
• Last Update Submitted That Met QC Criteria: August 30, 2022
• Last Verified: August 1, 2022

More Information

Terms related to this study

• Keywords: AIDS; latinos; hispanic; bictegravir; rapid start; rapid art initiation; latinx; advanced HIV
• Additional Relevant MeSH Terms: Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Antiviral Agents; Reverse Transcriptase Inhibitors; Nucleic Acid Synthesis Inhibitors; Enzyme Inhibitors; Anti-HIV Agents; Anti-Retroviral Agents; Tenofovir; Emtricitabine; Emtricitabine tenofovir alafenamide
• Other Study ID Numbers: VAC-AHORA-1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: 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).

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No