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

Last updated: August 21, 2024
Sponsor: Chang Gung Memorial Hospital
Overall Status: Active - Recruiting

Phase

3

Condition

N/A

Treatment

cabotegravir/rilpivirine (600mg/ 900mg)

Antiretroviral Combinations

Clinical Study ID

NCT06507059
202301496A3
MOHW113-CDC-C-114-000106
  • Ages > 18
  • All Genders

Study Summary

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Willing to sign the written informed consent form for male and female participantsaged 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 (provideaccurate and reachable phone numbers, social accounts like Line, or reliable contactinformation of family or friends).

  • Willing to receive gluteal (buttocks) drug injections.

  • Willing to transition back to oral medication or follow the recommended treatmentprescription according to the then-current national treatment guidelines afterdiscontinuation of long-acting injectable drugs.

Exclusion

Exclusion Criteria:

  • For those currently undergoing oral antiretroviral therapy, who have started orrestarted oral ART for less than six consecutive months before screening.

  • Previously undergone HIV drug resistance testing and known to have resistancemutations 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 oftransitioning 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.

Study Design

Total Participants: 40
Treatment Group(s): 2
Primary Treatment: cabotegravir/rilpivirine (600mg/ 900mg)
Phase: 3
Study Start date:
July 19, 2024
Estimated Completion Date:
December 31, 2026

Study Description

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.

Connect with a study center

  • Chang Gung Memorial Hospital, Keelung

    Keelung, 204
    Taiwan

    Active - Recruiting

  • Chang Gung Memorial Hospital, Taipei

    Taipei, 105
    Taiwan

    Active - Recruiting

  • Chang Gung Memorial Hospital, Linkou

    Taoyuan, 333
    Taiwan

    Active - Recruiting

  • Taoyuan General Hospital, Ministry of Health and Welfare

    Taoyuan, 330
    Taiwan

    Active - Recruiting

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