The goal of this clinical trial is to evaluate the efficacy and safety of different antiretroviral therapy (ART) strategies in adults with AIDS-related lymphoma (ARL) receiving anti-lymphoma treatment. The main questions it aims to answer are: Does long-acting injectable ART, including albuvirtide (ABT) or long-acting cabotegravir/rilpivirine (CAB/RPV), improve virological suppression compared with oral ART during anti-lymphoma treatment? Do different ART strategies differ in immune recovery, virological failure, low-level viremia, and safety in patients with ARL? Researchers will compare three treatment strategies-oral ART alone, oral ART plus long-acting albuvirtide (ABT), and long-acting cabotegravir/rilpivirine (CAB/RPV)-to determine whether long-acting injectable ART provides better virological control and comparable safety during lymphoma treatment. Participants will: Receive one of three ART strategies according to their clinical condition and treatment preference while receiving standard anti-lymphoma therapy. Attend scheduled study visits at baseline and Weeks 4, 8, 12, 24, 36, and 48. Undergo plasma HIV-1 RNA testing, CD4+ T-cell count measurement, laboratory assessments, and safety evaluations throughout the 48-week follow-up period. Be monitored for virological suppression, immune recovery, adverse events, and lymphoma-related clinical outcomes.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
60
Bictegravir/Emtricitabine/Tenofovir Alafenamide (BIC/FTC/TAF) or Current Oral ART Regimen at lymphoma diagnosis
Albuvirtide 640 mg intravenously every 4 weeks for five doses.
long-acting intramuscular cabotegravir and rilpivirine according to the approved dosing schedule.
Shanghai Public Health Clinical Center
Shanghai, Shanghai Municipality, China
RECRUITINGVirological Suppression Rate at Week 24
Percentage of participants achieving plasma HIV RNA \<50 copies/mL at Week 24.
Time frame: Week 24
CD4 Cell Count Change
Change from baseline in CD4+ T-cell count.
Time frame: Week 24 Week 48
Low-Level Viremia
Percentage of participants with HIV RNA between 50 and 200 copies/mL.
Time frame: Week 24 and Week 48
Virological Failure
Percentage of participants with HIV RNA ≥200 copies/mL.
Time frame: Week 24
Adverse Events
Incidence of adverse events and serious adverse events.
Time frame: Baseline through Week 48
Virological Suppression Rate at Week 48
Percentage of participants achieving plasma HIV RNA \<50 copies/mL at Week 48.
Time frame: Week 48.
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