HIV-1-infectionAHORANCT05526118
Advanced HIV: Outcomes for Rapid ART
An observational study of HIV-1-infection, run by Valley AIDS Council.
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… Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- HIV-1-infection
- What is being tested?
- Bictegravir/emtricitabine/tenofovir alafenamide
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- 30 Aug 2022to 15 Jan 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
No sites are listed yet.
About this study
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.
Read the 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.
- Conditions
- HIV-1-infection
- Being tested
- Bictegravir/emtricitabine/tenofovir alafenamide
- Keywords
- rapid start, rapid art initiation, bictegravir, hispanic, latinx, latinos, advanced HIV, AIDS
- Medical subject headings
- Acquired Immunodeficiency Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bictegravir/emtricitabine/tenofovir alafenamideDrug
Also called Biktarvy
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.
| Study group | Role | What they receive |
|---|---|---|
| AHORA group | All 50 prospective subjects are enrolled into a single cohort, all subjects must meet inclusion/exclusion criteria Receives: Drug: Bictegravir/emtricitabine/tenofovir alafenamide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Viral Suppression
To evaluate efficacy and time to HIV viral suppression of Biktarvy in Rapid Start setting for persons with Advanced HIV
Measured: 24 weeks
Secondary outcomes (4)
Viral Suppression
To evaluate efficacy, continued viral suppression of Biktarvy through 48 weeks.
Measured: 48 weeks
CD4 cell recovery
Secondary objectives would be to evaluate immune function recovery via absolute CD4 cell count
Measured: 48 weeks
CD4 cell recovery
Secondary objectives would be to evaluate immune function recovery via percent CD4 cell count
Measured: 48 weeks
CD4 cell recovery
Secondary objectives would be to evaluate immune function recovery via CD4/CD8 ratio
Measured: 48 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Sep 2022
- Study start30 Aug 2022 (estimated)
- Primary completion30 Aug 2024 (estimated)
- Study completion15 Jan 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIV-1-infectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Valley AIDS Council
- Sponsor type
- University, hospital or other
- Collaborators
- Gilead Sciences
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05526118
- Sponsor's protocol ID
- VAC-AHORA-1
- Acronym
- AHORA
- Status last verified
- Aug 2022
- First submitted
- 25 Jul 2022
- Last updated
- 2 Sep 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: 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).
Study at a glance
From the registry record, last updated by the sponsor on 2 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Advanced HIV: Outcomes for Rapid ART
- ClinicalTrials.gov ID
- NCT05526118
- Acronym / sponsor ID
- AHORA / VAC-AHORA-1
- Conditions
- HIV-1-infection
- Keywords
- rapid start, rapid art initiation, bictegravir, hispanic, latinx, latinos, advanced HIV, AIDS
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Valley AIDS CouncilUniversity, hospital or other
- Collaborators
- Gilead Sciences
- Study start
- 30 Aug 2022 (estimated)
- Primary completion
- 30 Aug 2024 (estimated)
- Study completion
- 15 Jan 2025 (estimated)
- First posted
- 2 Sep 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| AHORA group | – | Drug: Bictegravir/emtricitabine/tenofovir alafenamideAll 50 prospective subjects are enrolled into a single cohort, all subjects must meet inclusion/exclusion criteria |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Bictegravir/emtricitabine/tenofovir alafenamideAlso: BiktarvyPatients 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. | Drug | AHORA group |
Primary outcome
Viral Suppression
Time frame: 24 weeks
To evaluate efficacy and time to HIV viral suppression of Biktarvy in Rapid Start setting for persons with Advanced HIV
4 secondary outcomes
Viral Suppression
Time frame: 48 weeks
CD4 cell recovery
Time frame: 48 weeks
CD4 cell recovery
Time frame: 48 weeks
CD4 cell recovery
Time frame: 48 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Sep 2022.
- Individual participant dataSharing planned: No. 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).
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
An observational study of HIV-1-infection, run by Valley AIDS Council.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 2 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Dora A Martinez, MD (956-428-2653, dmartinez@westbrookclinic.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Viral Suppression (time frame: 24 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Sep 2022; AzTrials last refreshed its copy on 1 Nov 2026.