Optimization of Antiretroviral Therapy in Patients With AIDS-Related Lymphoma
OPT-ARL
1 other identifier
interventional
60
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started May 2026
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 26, 2026
CompletedFirst Submitted
Initial submission to the registry
July 22, 2026
CompletedFirst Posted
Study publicly available on registry
July 27, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
July 1, 2028
July 27, 2026
July 1, 2026
2.1 years
July 22, 2026
July 22, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Virological Suppression Rate at Week 24
Percentage of participants achieving plasma HIV RNA \<50 copies/mL at Week 24.
Week 24
Secondary Outcomes (5)
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.
Study Arms (3)
Oral ART
OTHERParticipants will receive standard oral antiretroviral therapy throughout lymphoma treatment.
Oral ART Plus Albuvirtide
OTHERParticipants with viremia who agree to receive long-acting therapy will receive oral ART combined with intravenous albuvirtide.
Long-Acting Cabotegravir/Rilpivirine
OTHEREligible participants will receive long-acting intramuscular cabotegravir and rilpivirine according to the approved dosing schedule.
Interventions
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.
Eligibility Criteria
You may qualify if:
- \- Age ≥18 years. Confirmed HIV infection. Histologically confirmed AIDS-related lymphoma. Receiving anti-lymphoma treatment. Able and willing to provide written informed consent.
You may not qualify if:
- \- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Shanghai Public Health Clinical Center
Shanghai, Shanghai Municipality, 201508, China
Related Publications (2)
Sax PE, Thompson MA, Saag MS; IAS-USA Treatment Guidelines Panel. Updated Treatment Recommendation on Use of Cabotegravir and Rilpivirine for People With HIV From the IAS-USA Guidelines Panel. JAMA. 2024 Mar 26;331(12):1060-1061. doi: 10.1001/jama.2024.2985. No abstract available.
PMID: 38427337RESULTFu Y, Xie X, Gan L, Yang X, Song Y, Song C, Sun F, Guo L, Long H. Safety, pharmacokinetics, and efficacy of albuvirtide administered by intravenous bolus every 4 weeks in combination with oral dolutegravir in virologically suppressed adults living with HIV: A 24-week study. Int J Infect Dis. 2026 Jan;162:108163. doi: 10.1016/j.ijid.2025.108163. Epub 2025 Oct 25.
PMID: 41429707RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER GOV
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Chief Physician
Study Record Dates
First Submitted
July 22, 2026
First Posted
July 27, 2026
Study Start
May 26, 2026
Primary Completion (Estimated)
July 1, 2028
Study Completion (Estimated)
July 1, 2028
Last Updated
July 27, 2026
Record last verified: 2026-07
Data Sharing
- IPD Sharing
- Will not share