Advanced HIV: Outcomes for Rapid ART

HIV-1-infection Clinical Trial

— AHORA  

Official title:

Advanced HIV: Outcomes for Rapid ART

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05526118
• Other study ID #: VAC-AHORA-1
• Status: Not yet recruiting
• Start date: August 30, 2022
• Est. completion date: January 15, 2025

Study information

• Verified date: August 2022
• Source: Valley AIDS Council
• Contact: Dora A Martinez, MD
• Phone: 956-428-2653
• Email: dmartinez[@]westbrookclinic.org
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 50
• Est. completion date: January 15, 2025
• Est. primary completion date: August 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

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

Related Conditions & MeSH terms

• HIV-1-infection

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Valley AIDS Council	Gilead Sciences

Outcome

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