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

Phase 3

Recruiting

• Conditions: HIV-1-infection; Non-Adherence, Medication

• Registration Number: NCT06507059
• Lead Sponsor: Chang Gung Memorial Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2024-7-7
• Last Update Posted: 2 September 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

Inclusion Criteria:<br><br> - Willing to sign the written informed consent form for male and female participants<br> aged 18 and above.<br><br> - At the time of enrollment, diagnosed with HIV infection for a minimum of 12 months.<br><br> - Under oral antiretroviral treatment (ART), which can be irregular or interrupted,<br> with the most recent viral load = 200 copies/mL.<br><br> - Body weight = 35Kg.<br><br> - Willing to maintain contact with the research team throughout the study (provide<br> accurate and reachable phone numbers, social accounts like Line, or reliable contact<br> information of family or friends).<br><br> - Willing to receive gluteal (buttocks) drug injections.<br><br> - Willing to transition back to oral medication or follow the recommended treatment<br> prescription according to the then-current national treatment guidelines after<br> discontinuation of long-acting injectable drugs.<br><br>Exclusion Criteria:<br><br> - For those currently undergoing oral antiretroviral therapy, who have started or<br> restarted oral ART for less than six consecutive months before screening.<br><br> - Previously undergone HIV drug resistance testing and known to have resistance<br> mutations to either cabotegravir or rilpivirine.<br><br> - Unable to commit to maintaining contact with the research team throughout the study.<br><br> - Individuals who cannot receive treatment for hepatitis B during the period of<br> transitioning to long-acting injections, if they are hepatitis B carriers.<br><br> - Individuals with buttock fillers.<br><br> - Women who are planning to become pregnant, pregnant, or currently breastfeeding.

Exclusion Criteria

Not provided

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
HIV-1 RNA <200 copies/mL

Secondary Outcome Measures

Name	Time	Method
HIV-1 RNA <50 copies/mL;HIV-1 RNA <200 copies/mL;Change of plasma HIV-1 viral load;Change of CD4 count;Occurrence of HIV and non-HIV related conditions;Lost F/U rate;Usage of outreach drug delivery service;Resistant variant emergence;Adverse events;Discontinuation due to AEs;Change of depression score;Change of self-stigma score;Change of metabolic parameters