Accelerated ART Initiation for HIV

(ACCELERATE Trial)

Recruiting in Saint Louis (>99 mi)

+3 other 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

Trial Summary

What is the purpose of this trial?

The main purpose of the study is to evaluate the effectiveness, of the ACCELERATE model of care to achieve HIV viral suppression at Week 24. The study will also assess the acceptability, appropriateness, feasibility, and sustainability of the ACCELERATE model of care. The ACCELERATE model combines a standardized method for outreach, the use of telehealth for rapid access to an HIV care provider, a simplified pre-approved HIV regimen, a free 30-day medication starter supply, and re-linkage to medical care.

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 data supports the effectiveness of the drug Biktarvy (bictegravir/emtricitabine/tenofovir alafenamide) for treating HIV?

Research shows that Biktarvy is effective in maintaining viral suppression in people with HIV, with studies demonstrating its safety and tolerability over 96 weeks. It is recommended as a once-daily single-tablet regimen for people living with HIV, including those who are older than 55 years. ^{1 2 3 4 5}

Is the treatment with bictegravir/emtricitabine/tenofovir alafenamide generally safe for humans?

The treatment with bictegravir, emtricitabine, and tenofovir alafenamide has been shown to be generally safe and well-tolerated in people with HIV, including older adults and females, with similar safety profiles to other HIV treatments. ^{1 2 6 7 8}

How is the drug Biktarvy different from other HIV treatments?

Biktarvy is unique because it combines three medications (bictegravir, emtricitabine, and tenofovir alafenamide) into a single daily pill, making it easier for patients to take. It is recommended for people who are new to HIV treatment or those who have a stable treatment history, and it may be better tolerated than some other similar treatments. ^{1 2 3 5 7}

Research Team

Dima Dandachi, MD

Principal Investigator

University of Missouri-Columbia

Eligibility Criteria

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

I understand and can follow the study's requirements.

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

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

Treatment Details

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).

Participant Groups

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

Findings from Research

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]

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 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]

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]

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]

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]

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]

References

1. Netherlands 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. [2021]

2. Netherlands 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. [2022]

3. United States pubmed.ncbi.nlm.nih.gov

Brief Report: Pharmacokinetics of Bictegravir and Tenofovir in Combination With Darunavir/Cobicistat in Treatment-Experienced Persons With HIV. [2023]

4. England pubmed.ncbi.nlm.nih.gov

Coformulated bictegravir, emtricitabine, tenofovir alafenamide after initial treatment with bictegravir or dolutegravir and emtricitabine/tenofovir alafenamide. [2019]

5. Switzerland 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. [2023]

6. Netherlands 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. [2021]

7. New Zealand 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. [2021]

8. United States 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. [2023]