AIDS-related Lymphoma, HIV Infection
Conditions
Keywords
HIV, AIDS-Related Lymphoma, Antiretroviral Therapy, Albuvirtide, Cabotegravir, Rilpivirine, Long-Acting Injectable ART, Virological Suppression
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.
Interventions
DRUGOral Antiretroviral Therapy
Bictegravir/Emtricitabine/Tenofovir Alafenamide (BIC/FTC/TAF) or Current Oral ART Regimen at lymphoma diagnosis
DRUGalbuvirtide
Albuvirtide 640 mg intravenously every 4 weeks for five doses.
long-acting intramuscular cabotegravir and rilpivirine according to the approved dosing schedule.
Sponsors
Shanghai Public Health Clinical Center
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Virological Suppression Rate at Week 24 | Week 24 | Percentage of participants achieving plasma HIV RNA \<50 copies/mL at Week 24. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| CD4 Cell Count Change | Week 24 Week 48 | Change from baseline in CD4+ T-cell count. |
| Low-Level Viremia | Week 24 and Week 48 | Percentage of participants with HIV RNA between 50 and 200 copies/mL. |
| Virological Failure | Week 24 | Percentage of participants with HIV RNA ≥200 copies/mL. |
| Adverse Events | Baseline through Week 48 | Incidence of adverse events and serious adverse events. |
| Virological Suppression Rate at Week 48 | Week 48. | Percentage of participants achieving plasma HIV RNA \<50 copies/mL at Week 48. |
Countries
China
Contacts
CONTACTZhenyan Wang
Outcome results
None listed