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Optimization of Antiretroviral Therapy in Patients With AIDS-Related Lymphoma During Anti-Lymphoma Treatment: A Multicenter Prospective Non-Randomized Controlled Study

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• \- Age ≥18 years. Confirmed HIV infection. Histologically confirmed AIDS-related lymphoma. Receiving anti-lymphoma treatment. Able and willing to provide written informed consent.

Locations
Other Locations
China
Shanghai Public Health Clinical Center
RECRUITING
Shanghai
Contact Information
Primary
Zhenyan Wang
wangzhenyan@shaphc.org
+86021-37990333-3222
Time Frame
Start Date: 2026-05-26
Estimated Completion Date: 2028-07
Participants
Target number of participants: 60
Treatments
Other: Oral ART
Participants will receive standard oral antiretroviral therapy throughout lymphoma treatment.
Other: Oral ART Plus Albuvirtide
Participants with viremia who agree to receive long-acting therapy will receive oral ART combined with intravenous albuvirtide.
Other: Long-Acting Cabotegravir/Rilpivirine
Eligible participants will receive long-acting intramuscular cabotegravir and rilpivirine according to the approved dosing schedule.
Sponsors
Leads: Shanghai Public Health Clinical Center

This content was sourced from clinicaltrials.gov

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