Optimization of Antiretroviral Therapy in Patients With AIDS-Related Lymphoma

Condition(s) studied

Investigational drug(s) / intervention(s)

Oral Antiretroviral Therapy: Bictegravir/Emtricitabine/Tenofovir Alafenamide (BIC/FTC/TAF) or Current Oral ART Regimen at lymphoma diagnosis

albuvirtide: Albuvirtide 640 mg intravenously every 4 weeks for five doses.

Cabotegravir/Rilpivirine: long-acting intramuscular cabotegravir and rilpivirine according to the approved dosing schedule.

Study summary

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.

Eligibility

Primary outcome measure(s)

• Virological Suppression Rate at Week 24 — Week 24
  Percentage of participants achieving plasma HIV RNA \<50 copies/mL at Week 24.

Trial sites (1)

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