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

NCT06507059 | Recruiting Phase 3 DMC

• 2 other identifiers: 202301496A3MOHW113-CDC-C-114-000106
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 4

Brief 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.

Conditions

HIV-1-infection; Non-Adherence, Medication

Keywords

HIV-1, non-adherence

Outcome Measures

Primary Outcomes (1)

• HIV-1 RNA <200 copies/mL

  Percentage of study participants with plasma HIV-1 RNA \<200 copies/mL at week 24

  Week 24

Secondary Outcomes (13)

• HIV-1 RNA <50 copies/mL

  Week 24, week 52

• HIV-1 RNA <200 copies/mL

  Week 52

• Change of plasma HIV-1 viral load

  Week 24, week 52

• Change of CD4 count

  Week 24, week 52

• Occurrence of HIV and non-HIV related conditions

  Week 24, week 52

Other Outcomes (4)

• Achieved ART trough level assessment

  Week 52

• Change of acceptability score

  Day1 (post-injection), week 24, 52 for the immediate LA treatment group; week 24 (post-injection), and week 52 for the delayed switch to LA group.

• Delayed injections

  up to week 52

Study Arms (2)

Immediate Long-Acting Injectable Treatment Group

EXPERIMENTAL

Immediate switch to long-acting injectable antiretrovirals on enrollment

Drug: cabotegravir/rilpivirine (600mg/ 900mg)

Delayed Long-Acting Injectable Treatment Group

ACTIVE COMPARATOR

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

Drug: Antiretroviral Combinations

Interventions

cabotegravir/rilpivirine (600mg/ 900mg) DRUG

Immediate switch from oral antiretroviral to long-acting injectables

Also known as: Cabenuva

Immediate Long-Acting Injectable Treatment Group

Antiretroviral Combinations DRUG

Standard all-oral antiretroviral combinations

Delayed Long-Acting Injectable Treatment Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Chang Gung Memorial Hospital: lead
• Taoyuan General Hospital: collaborator

Study Sites (4)

Chang Gung Memorial Hospital, Keelung

Keelung, 204, Taiwan

RECRUITING

Chang Gung Memorial Hospital, Taipei

Taipei, 105, Taiwan

RECRUITING

Taoyuan General Hospital, Ministry of Health and Welfare

Taoyuan District, 330, Taiwan

RECRUITING

Chang Gung Memorial Hospital, Linkou

Taoyuan District, 333, Taiwan

RECRUITING

MeSH Terms

Conditions

Medication Adherence

Interventions

cabotegravir; Rilpivirine; cabotegravir, rilpivirine drug combination

Condition Hierarchy (Ancestors)

Patient Compliance; Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior

Intervention Hierarchy (Ancestors)

Nitriles; Organic Chemicals; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Nan-Yu Chen, MD, PhD

  Chang Gung Memorial Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Nan-Yu Chen, MD, PhD

CONTACT

+886 3 3281200; nanyuchen@cgmh.org.tw

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 7, 2024
• First Posted: July 18, 2024
• Study Start: July 19, 2024
• Primary Completion: July 1, 2025
• Study Completion (Estimated): December 31, 2026
• Last Updated: August 23, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

TW (4)