Optimization of Antiretroviral Therapy in Patients With AIDS-Related Lymphoma
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Oral Antiretroviral Therapy, albuvirtide, Cabotegravir/Rilpivirine.
- Who it may be relevant to
- Registry conditions: AIDS-related Lymphoma, HIV Infection. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Optimization of Antiretroviral Therapy in Patients With AIDS-Related Lymphoma During Anti-Lymphoma Treatment: A Multicenter Prospective Non-Randomized Controlled Study
Overview
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
- Drug Oral Antiretroviral Therapy
Bictegravir/Emtricitabine/Tenofovir Alafenamide (BIC/FTC/TAF) or Current Oral ART Regimen at lymphoma diagnosis - Drug albuvirtide
Albuvirtide 640 mg intravenously every 4 weeks for five doses. - Drug Cabotegravir/Rilpivirine
long-acting intramuscular cabotegravir and rilpivirine according to the approved dosing schedule.
Primary outcome measures
- Virological Suppression Rate at Week 24 [Time frame: Week 24]
Secondary outcome measures (5)
- CD4 Cell Count Change [Time frame: Week 24 Week 48]
- Low-Level Viremia [Time frame: Week 24 and Week 48]
- Virological Failure [Time frame: Week 24]
- Adverse Events [Time frame: Baseline through Week 48]
- Virological Suppression Rate at Week 48 [Time frame: Week 48.]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Non-randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
China · 1 center
- Shanghai Public Health Clinical Center — Shanghai
Publications
- 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 38427337
- Fu 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 41429707
Identifiers
NCT: NCT07727642 · 2025-S128-04