Outcomes of the PLHIV With Suboptimal Viral Suppression to Injectable Long-acting Antiretrovirals

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE3

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-07-19

Study Completion Date

2026-12-31

Brief Summary

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This study aims to determine whether people living with HIV (PLHIV) with suboptimal medical adherence can achieve better viral suppression with long-acting antiretrovirals (LA) compared to all-oral antiretrovirals.

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Detailed Description

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This is an open-label, multi-center, randomized, active-controlled, superiority trial on 40 adult subjects who had been diagnosed to have HIV infection for at least 12 months before enrollment but with suboptimal viral suppression despite antiretroviral treatment (ART), with the latest HIV-1 viral load ≥ 200 copies/mL. Participants' eligibility will be assessed through a review of their medical records, and individuals with established resistance to cabotegravir or rilpivirine will be excluded. Enrolled participants will then be randomized 1:1 to either "Delayed Switch to LA Treatment Group" or "Immediate LA Treatment Group" on enrollment. The "Delayed Switch to LA Treatment Group" will also switch to LA on week 24. The proportion of participants with HIV-1 RNA \<200 copies/mL at week 24 in the two study groups will be compared. Psychologic assessments including self-stigma and depression assessment will also be performed on day1, at week 24 and week 52.

Conditions

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HIV-1-infection Non-Adherence, Medication

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Immediate Long-Acting Injectable Treatment Group

Immediate switch to long-acting injectable antiretrovirals on enrollment

Group Type EXPERIMENTAL

cabotegravir/rilpivirine (600mg/ 900mg)

Intervention Type DRUG

Immediate switch from oral antiretroviral to long-acting injectables

Delayed Long-Acting Injectable Treatment Group

Keep on standard all-oral antiretrovirals on enrollment for 24 weeks, then switch to long-acting injectable antiretrovirals

Group Type ACTIVE_COMPARATOR

Antiretroviral Combinations

Intervention Type DRUG

Standard all-oral antiretroviral combinations

Interventions

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cabotegravir/rilpivirine (600mg/ 900mg)

Immediate switch from oral antiretroviral to long-acting injectables

Intervention Type DRUG

Antiretroviral Combinations

Standard all-oral antiretroviral combinations

Intervention Type DRUG

Other Intervention Names

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Cabenuva

Eligibility Criteria

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Inclusion Criteria

* Willing to sign the written informed consent form for male and female participants aged 18 and above.
* At the time of enrollment, diagnosed with HIV infection for a minimum of 12 months.
* Under oral antiretroviral treatment (ART), which can be irregular or interrupted, with the most recent viral load ≥ 200 copies/mL.
* Body weight ≥ 35Kg.
* Willing to maintain contact with the research team throughout the study (provide accurate and reachable phone numbers, social accounts like Line, or reliable contact information of family or friends).
* Willing to receive gluteal (buttocks) drug injections.
* Willing to transition back to oral medication or follow the recommended treatment prescription according to the then-current national treatment guidelines after discontinuation of long-acting injectable drugs.

Exclusion Criteria

* For those currently undergoing oral antiretroviral therapy, who have started or restarted oral ART for less than six consecutive months before screening.
* Previously undergone HIV drug resistance testing and known to have resistance mutations to either cabotegravir or rilpivirine.
* Unable to commit to maintaining contact with the research team throughout the study.
* Individuals who cannot receive treatment for hepatitis B during the period of transitioning to long-acting injections, if they are hepatitis B carriers.
* Individuals with buttock fillers.
* Women who are planning to become pregnant, pregnant, or currently breastfeeding.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No