Optimization of Antiretroviral Therapy in Patients With AIDS-Related Lymphoma During Anti-Lymphoma Treatment: A Multicenter Prospective Non-Randomized Controlled Study
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Enrollment
- 60
- Locations
- 1
- Primary Endpoint
- Virological Suppression Rate at Week 24
Study Overview
Brief 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.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •- Age ≥18 years. Confirmed HIV infection. Histologically confirmed AIDS-related lymphoma. Receiving anti-lymphoma treatment. Able and willing to provide written informed consent.
Exclusion Criteria
- •- Expected survival less than 6 months. Severe concomitant malignancy or uncontrolled comorbidity. Refusal to receive antiretroviral therapy or lymphoma treatment. Contraindications to study medications. Inability to complete scheduled follow-up. Any condition considered unsuitable by the investigator.
Outcomes
Primary Outcomes
Virological Suppression Rate at Week 24
Time Frame: Week 24
Percentage of participants achieving plasma HIV RNA \<50 copies/mL at Week 24.
Secondary Outcomes
- CD4 Cell Count Change(Week 24 Week 48)
- Low-Level Viremia(Week 24 and Week 48)
- Virological Failure(Week 24)
- Adverse Events(Baseline through Week 48)
- Virological Suppression Rate at Week 48(Week 48.)
Investigators
Zhenyan Wang
Associate Chief Physician
Shanghai Public Health Clinical Center