The Antiretroviral Speed Access Program Switch (ASAP-Switch) Study

Официальное название

Antiretroviral Speed Access Program Switch Study (The ASAP Switch Study) - A Pilot Study to Switch ART-experienced and Newly-referred Migrant People With HIV to B/F/TAF

Обзор

This project builds on our experience with the ASAP Study (McGill University Health Centre research ethics board: MP-37-2020-4911). The goal of this study is to better understand the experience of migrant people with Human Immunodeficiency Virus (HIV) of having their treatment switched to Bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF). In other words, the investigators want to evaluate how feasible and acceptable this switch is, and how participants will take B/F/TAF (fidelity) and remain on it. The investigators also want to know more about migrant people with HIV's experience of care; namely, how often they see their HIV specialist or other healthcare professionals, and their healthcare coverage (the type of insurance that they have).

Подробное описание

International migrants represent an increasing portion of people with HIV in Canada. Making sure migrant people with HIV have access to treatment and care is crucial for their health and wellbeing. It is also important to make sure that they have a good experience of care and treatment. Several treatments exist for HIV, and many migrant people with HIV arrive in Quebec with a current or past experience of taking an HIV treatment. Sometimes, it is a treatment that cannot be continued here, for different reasons. Thus, their treatment must be 'switched', that is, changed to another treatment more affordable, simpler, or more efficient.

B/F/TAF is one HIV treatment. B/F/TAF is simple to take (one small-sized pill a day), safe, highly effective for almost all people with HIV, and ideal when one switches from one treatment to another. If participants take part in this study, their treatment will be switched to B/F/TAF; it will be provided free of charge for the participants.

The goal of this study is to better understand the experience of migrant people with HIV of having their treatment switched to B/F/TAF. In other words, the investigators want to evaluate how feasible and acceptable this switch is, and how participants will take B/F/TAF (fidelity) and remain on it. The investigators also want to know more about migrant people with HIV's experience of care; namely, how often they see their HIV specialist or other healthcare professionals, and their healthcare coverage (the type of insurance that they have).

Вмешательства

• Препарат B/F/TAF
  The intervention consists of prescribing B/F/TAF to eligible ART-experienced migrant patients, free of charge, in four care settings, for 12 months (48 weeks). B/F/TAF is a fixed-dose combination of bictegravir (50 mg), emtricitabine (200 mg), and tenofovir alafenamide (25 mg), administered orally, once daily, without food requirements.

Первичные конечные точки

• Feasibility of the switch [Срок оценки: within 7 days of first clinic visit]
• Acceptability [Срок оценки: From baseline to week 48.]
• acceptability of the regimen [Срок оценки: From baseline to week 48.]
• Acceptability of the intervention [Срок оценки: From baseline to week 48.]
• Fidelity [Срок оценки: From enrolment to week 72.]

Вторичные конечные точки (6)

• ART initiation (HIV care cascade milestones) [Срок оценки: From enrolment to baseline.]
• Viral suppression (HIV care cascade milestones) [Срок оценки: From enrolment to week 72 or until viral suppression happens (whichever comes first).]
• Retention in HIV care (HIV care cascade milestones) [Срок оценки: From enrolment to week 48.]
• consultations at the study site (Nature of clinical pathways) [Срок оценки: From enrolment to week 72.]
• consultations at other care centres or organizations (Nature of clinical pathways) [Срок оценки: From enrolment to week 72.]
• healthcare coverage [Срок оценки: From enrolment to week 72.]

Критерии участия

Критерии включения

• Willing and able to understand the requirements of study participation and provide signed and dated written informed consent prior to performing study procedures;
• 18 years of age or older;
• Living with HIV (type 1) (as confirmed by a fourth generation HIV Ag/Ab combination assay);
• Patients at their first visits ever at the study site;
• Born outside of Canada, and arrived in the province of Quebec from another province or country to reside temporarily or permanently in the last 24 months;
• ART-experienced, that is, with past or current experience of taking ART to treat HIV, with or without treatment interruption(s) for any clinical or personal reason;
• Individuals assigned female at birth may be eligible to enter and participate in the study in the following circumstances:

• is of non-child-bearing potential defined as either post-menopausal (12 months of spontaneous amenorrhea and 45 years of age) or physically incapable of becoming pregnant with documented tubal ligation, hysterectomy, or bilateral oophorectomy or,
• is of child-bearing potential with a negative pregnancy test at Screening (\& baseline visit) and reporting no plans to become pregnant in the next year.

Patients with documented historical resistance to HIV-1 reverse transcriptase inhibitors will be eligible, including: M184I/V alone or in combination with up to 2 thymidine analogue-associated mutations (TAMs) (M41L, D67N, K70R, L210W, T215F/Y, or K219Q/E/N/R).

Критерии исключения

• Pregnant, breastfeeding, or planning to become pregnant;
• Current alcohol or substance use judged by the investigator to potentially interfere with participant study compliance;
• Active tuberculosis infection;
• Acute hepatitis < 30 days before enrollment;
• Known hypersensitivity to B/F/TAF, its metabolite or formulation excipient;
• Documented or suspected resistance to integrase inhibitors as per clinical judgment (e.g., history of poor adherence and/or poor virological control on an InSTI-based regimen);
• Documented multi-NRTI resistance mutations/substitutions: K65R/N/E, T69 insertion, or 3 or more TAMs (M41L, D67N, K70R, L210W, T215F/Y, K219E/Q);
• Any of the following laboratory values at screening:

• Alkaline Phosphatase>3 × ULN
• aspartate aminotransferase (AST) >5 × upper limit of normal
• alanine aminotransferase (ALT) >5 × upper limit of normal
• Hemoglobin<8.0 g/dL
• Estimated creatinine clearance (CrCL) ≤30 mL/min/1.73 m2 based on the Cockcroft-Gault equation for creatinine clearance (CLcr)
• Platelets< 50,000/mm3
• Participation or planned participation in any other clinical study (including observational studies) without prior approval from the sponsor;
• Any reason, in the opinion of the investigator, which would make the candidate inappropriate for participation in an investigative study involving oral medications (e.g., inability to understand the study information leaflet, to provide written consent);
• Concomitant use of drugs with contraindication or drug-drug interactions with B/F/TAF;
• Active malignancy requiring acute systemic therapy;
• History of or current clinical decompensated liver cirrhosis (e.g., ascites, encephalopathy, or variceal bleedings).

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Канада · 1 центр

• Research Institute of the McGill University Health Centre — Montreal

Идентификаторы

NCT: NCT06375304 · MP-37-2024-10384

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗