Accelerated ART Initiation for HIV

(ACCELERATE Trial)

Recruiting at 4 trial locations

Overseen By Hilal Abdessamad, MD

Age: 18+

Sex: Any

Trial Phase: Phase 4

Sponsor: University of Missouri-Columbia

Must not be taking: Biktarvy contraindicated meds

Disqualifiers: Chronic kidney disease, Pregnancy, HIV-2, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 24

Duration: 24 weeks

120 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new approach to quickly start HIV treatment and achieve viral suppression within 24 weeks. It employs a fast-track care model with telehealth appointments, a pre-approved HIV medication (bictegravir/emtricitabine/tenofovir alafenamide, also known as Biktarvy), and a free 30-day supply of medication to initiate treatment. People with HIV who haven't seen a doctor for over six months and haven't been on treatment for at least a month might be suitable candidates. The trial also evaluates the practicality and acceptability of this care model for patients and healthcare providers. As a Phase 4 trial, this research aims to understand how this FDA-approved and effective treatment benefits more patients.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but it does mention that certain medications cannot be taken with the study drug. It's best to discuss your current medications with the study team to see if any adjustments are needed.

What is the safety track record for bictegravir/emtricitabine/tenofovir alafenamide and the Accelerate model of care?

Research has shown that the treatment using bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF) is generally safe for people with HIV. In studies, this combination proved very effective, and most participants did not experience serious side effects. After 24 weeks, up to 94% of patients had their HIV levels drop to very low amounts. Another study found that 92% of participants maintained these low levels after a year, with no major issues reported.

The Accelerate model of care does not introduce a new physical treatment but aims to enhance how patients begin and continue their HIV care. This includes offering online doctor visits and quickly providing a starter supply of medication. There are no direct safety concerns with this model, as it focuses on how care is delivered rather than introducing new medicines. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

Researchers are excited about the Accelerate Model of Care for HIV treatment because it speeds up the time it takes for patients to start antiretroviral therapy. Unlike traditional methods which often involve waiting for multiple appointments, this model ensures patients can connect with an HIV care provider via telehealth within 24 business hours. Additionally, patients receive a free 30-day starter pack of bictegravir/emtricitabine/tenofovir alafenamide, allowing them to begin treatment immediately while their insurance benefits are verified. This rapid initiation could lead to quicker viral suppression, improving health outcomes and reducing the risk of transmission.

What evidence suggests that the Accelerate model of care is effective for achieving HIV viral suppression?

Research has shown that the combination of bictegravir, emtricitabine, and tenofovir alafenamide (B/F/TAF), which participants in this trial may receive, effectively treats HIV. One study found that 93.8% of patients had very low HIV levels by week 48. Another study reported that 100% of participants had their HIV under control after 24 months. This treatment controls the virus without causing major changes that could lead to resistance.

The Accelerate model of care, another component of this trial, quickly connects patients to HIV treatment. It uses tools like telehealth to reduce delays in starting care, potentially leading to better health outcomes. This model emphasizes fast access and support, which may help reduce missed treatment appointments. ^{6 7 8 9 10}

Who Is on the Research Team?

Dima Dandachi, MD

Principal Investigator

University of Missouri-Columbia

Are You a Good Fit for This Trial?

This trial is for people living with HIV who are not currently receiving care. Participants should be willing to try a new model of care called ACCELERATE, which includes outreach, telehealth services, a simplified HIV treatment regimen, and support for re-linking to medical care.

Inclusion Criteria

Speaks English

HIV care providers, case managers, pharmacists, or administrators involved in administrative or clinical aspects of the intervention at participating sites

Understand the long-term commitment to the study and be willing to participate

Exclusion Criteria

PLWH Participants who meet ANY of the following criteria are excluded:

Biktarvy is not suitable for my treatment.

Pregnant (by self-report) or planning to become pregnant while enrolled in the study

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants receive a telehealth appointment with an HIV care provider and are prescribed B/F/TAF, which is mailed as a free 30-day starter pack.

24 weeks

Telehealth appointment within 24 business hours, followed by a telephone follow-up call within 2-4 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment, with lab results drawn during clinic visits.

48 weeks

Regular clinic visits for lab tests and monitoring

Extension

Participants continue to be monitored for long-term outcomes and sustainability of the ACCELERATE model of care.

1 year

What Are the Treatments Tested in This Trial?

Interventions

• bictegravir/emtricitabine/tenofovir alafenamide
• The Accelerate model of care

Trial Overview

The study tests the effectiveness of the ACCELERATE model in achieving HIV viral suppression by Week 24. It involves rapid access to healthcare via telehealth and starting patients on a pre-approved medication regimen (bictegravir/emtricitabine/tenofovir alafenamide).

How Is the Trial Designed?

Group I: Accelerate Model of Care Experimental Treatment 2 Interventions

Contact is established by the study team The patient is provided with a telehealth appointment with an HIV care provider within 24 business hours of contact At the time of enrollment/initial clinic visit, patients who meet the inclusion and exclusion criteria will be enrolled in the study The HIV care provider will prescribe B/F/TAF to their pharmacy of choice. B/F/TAF is dispensed by the designated study pharmacist and mailed to the patient as a free 30-day starter pack to allow time for benefits verification. A telephone follow-up call by the study team will be conducted within 2 - 4 weeks from the initial clinical visit to assess any adverse events, tolerability, and adherence. Hand-off to HIV clinic to establish care within 4 weeks. Lab results will be drawn during clinic per HIV care provider which might include CBC, CMP, HIV-1 RNA, CD4, and genotype resistance testing when clinically indicated by the HIV care provider.

bictegravir/emtricitabine/tenofovir alafenamide is already approved in European Union, United States, Canada, Japan, Switzerland for the following indications:

Approved in European Union as Biktarvy for:

• HIV-1 infection

Approved in United States as Biktarvy for:

• HIV-1 infection

Approved in Canada as Biktarvy for:

• HIV-1 infection

Approved in Japan as Biktarvy for:

• HIV-1 infection

Approved in Switzerland as Biktarvy for:

• HIV-1 infection

Who Is Running the Clinical Trial?

University of Missouri-Columbia

Lead Sponsor

Trials

387

Recruited

629,000+

Gilead Sciences

Industry Sponsor

Trials

1,150

Recruited

878,000+

Daniel O'Day

Gilead Sciences

Chief Executive Officer since 2019

MBA from Columbia University

Dietmar Berger

Gilead Sciences

Chief Medical Officer

MD and PhD from Albert-Ludwigs University School of Medicine

Published Research Related to This Trial

In a study involving 631 treatment-naive adults with HIV-1, the fixed-dose combination of bictegravir, emtricitabine, and tenofovir alafenamide was found to be non-inferior to the combination of dolutegravir, abacavir, and lamivudine at week 96, with 88% of participants achieving undetectable HIV-1 RNA levels.

Bictegravir was associated with fewer adverse events compared to dolutegravir, with only 28% of participants reporting drug-related side effects, and no participants discontinuing treatment due to adverse events, highlighting its safety and tolerability.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Bictegravir combined with emtricitabine and tenofovir alafenamide versus dolutegravir, abacavir, and lamivudine for initial treatment of HIV-1 infection: week 96 results from a randomised, double-blind, multicentre, phase 3, non-inferiority trial. Wohl, DA., Yazdanpanah, Y., Baumgarten, A., et al.[2022]

In a phase 2 study involving initial antiretroviral therapy, both bictegravir and dolutegravir combined with emtricitabine and tenofovir alafenamide demonstrated excellent efficacy over 60 weeks.

After switching to a single-tablet regimen of bictegravir, all participants maintained viral suppression for 12 weeks in the open-label phase, indicating the treatment's safety and tolerability.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Coformulated bictegravir, emtricitabine, tenofovir alafenamide after initial treatment with bictegravir or dolutegravir and emtricitabine/tenofovir alafenamide. Sax, PE., DeJesus, E., Crofoot, G., et al.[2019]

In a 48-week study involving 86 older adults with HIV, switching to the medication bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF) resulted in a high rate of virologic suppression, with 90.7% of participants maintaining HIV-1 RNA levels below 50 copies/ml.

The treatment was well tolerated, with no serious adverse events related to the drug and a high adherence rate of 98.6%, indicating that B/F/TAF is a safe and effective option for older adults living with HIV.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Bictegravir/Emtricitabine/Tenofovir Alafenamide in Virologically Suppressed People with HIV Aged ≥ 65 Years: Week 48 Results of a Phase 3b, Open-Label Trial. Maggiolo, F., Rizzardini, G., Molina, JM., et al.[2021]

In a study involving 657 treatment-naive adults with HIV-1, the single-tablet regimen of bictegravir, emtricitabine, and tenofovir alafenamide demonstrated non-inferiority to the dolutegravir regimen at week 96, with 84% of participants achieving undetectable HIV-1 RNA levels.

Both treatment regimens were well tolerated over the 96 weeks, with similar rates of adverse events, indicating that bictegravir is a safe and effective long-term option for managing HIV.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Co-formulated bictegravir, emtricitabine, and tenofovir alafenamide versus dolutegravir with emtricitabine and tenofovir alafenamide for initial treatment of HIV-1 infection: week 96 results from a randomised, double-blind, multicentre, phase 3, non-inferiority trial. Stellbrink, HJ., Arribas, JR., Stephens, JL., et al.[2021]

Bictegravir/emtricitabine/tenofovir alafenamide fumarate (BIC/FTC/TAF) is an effective and well-tolerated treatment for people living with HIV, showing low rates of virologic failure after 96 weeks in a cohort of 164 participants, including 106 individuals over 55 years old.

The treatment led to significant improvements in CD4+ T cell counts and CD4+/CD8+ ratios without negatively impacting metabolic health, although some worsening of renal function was noted, indicating the need for ongoing monitoring.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Immune Reconstitution and Safe Metabolic Profile after the Switch to Bictegravir/Emtricitabine/Tenofovir Alafenamide Fumarate among Virologically Controlled PLWH: A 96 Week Update from the BICTEL Cohort. Lazzaro, A., Bianchini, D., Gentilini Cacciola, E., et al.[2023]

In a phase 3 trial involving 567 participants, switching to the fixed-dose combination of bictegravir, emtricitabine, and tenofovir alafenamide was found to be non-inferior to continuing dolutegravir, abacavir, and lamivudine, with only 1% of participants in the bictegravir group showing detectable HIV-1 RNA after 48 weeks.

The bictegravir regimen had a lower incidence of treatment-related adverse events (8%) compared to the dolutegravir regimen (16%), suggesting it may be a safer option for long-term HIV-1 treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Switching to fixed-dose bictegravir, emtricitabine, and tenofovir alafenamide from dolutegravir plus abacavir and lamivudine in virologically suppressed adults with HIV-1: 48 week results of a randomised, double-blind, multicentre, active-controlled, phase 3, non-inferiority trial. Molina, JM., Ward, D., Brar, I., et al.[2021]

Bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF) demonstrated high virologic suppression rates (≥95% for those virologically suppressed at baseline and ≥87% for ART-naive participants) after 48 weeks, indicating its efficacy across a diverse population of females living with HIV.

The treatment was well tolerated, with low rates of treatment-emergent adverse events (9.2% for B/F/TAF compared to 5.5% for comparator regimens) and no detected resistance, confirming its safety profile for long-term use.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Brief Report: Efficacy and Safety of Bictegravir/Emtricitabine/Tenofovir Alafenamide in Females Living With HIV: An Integrated Analysis of 5 Trials. Orkin, C., Ajana, F., Kityo, C., et al.[2023]

In a study of 9 treatment-experienced HIV patients, the combination of Bictegravir, Emtricitabine, and Tenofovir Alafenamide (BIC/FTC/TAF) with Darunavir/Cobicistat (DRV/c) showed a 26% increase in BIC exposure compared to historical data, indicating effective drug absorption in this population.

Despite increased exposure to Tenofovir Alafenamide (TAF), the levels of Tenofovir (TFV) remained only modestly elevated, suggesting that the combination regimen is safe and effective for managing HIV in patients with prior treatment experience.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Brief Report: Pharmacokinetics of Bictegravir and Tenofovir in Combination With Darunavir/Cobicistat in Treatment-Experienced Persons With HIV. Salama, E., Hill, L., Patel, N., et al.[2023]

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