Clinical trial NCT05526118: Advanced HIV: Outcomes for Rapid ART
Official title: Advanced HIV: Outcomes for Rapid ART
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: HIV-1-infection
Keywords: rapid start
rapid art initiation
bictegravir
hispanic
latinx
latinos
advanced HIV
AIDS
Lead sponsor: Valley AIDS Council
Sponsor class: OTHER
Collaborators: name: Gilead Sciences
First posted: 2022-09-02
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Viral Suppression
timeFrame: 24 weeks
Secondary outcomes:
measure: Viral Suppression
timeFrame: 48 weeks
measure: CD4 cell recovery
timeFrame: 48 weeks
measure: CD4 cell recovery
timeFrame: 48 weeks
measure: CD4 cell recovery
timeFrame: 48 weeks
Other outcomes:
measure: post-hoc analyses to evaluate potential associations of baseline characteristics on viral suppression
timeFrame: 48-72 weeks
measure: post-hoc analyses to evaluate potential associations of baseline characteristics on viral suppression
timeFrame: 48-72 weeks
measure: post-hoc analyses to evaluate potential associations of baseline characteristics on viral suppression
timeFrame: 48-72 weeks
measure: Post-hoc analyses to evaluate potential associations of baseline characteristics on viral suppression
timeFrame: 48-72 weeks
measure: Post-hoc analyses to evaluate potential associations of baseline characteristics on viral
timeFrame: 48-72 weeks
measure: Post-hoc analyses to evaluate potential associations of baseline characteristics on viral
timeFrame: 48-72 weeks
measure: Post-hoc analyses to evaluate potential associations of baseline characteristics on viral
timeFrame: 48-72 weeks
measure: Post-hoc analyses to evaluate potential associations of baseline characteristics on viral
timeFrame: 48-72 weeks
Locations:
Study officials:
References: