Clinical trial · Interventional
Optimization of Antiretroviral Therapy in Patients With AIDS-Related Lymphoma
Optimization of Antiretroviral Therapy in Patients With AIDS-Related Lymphoma During Anti-Lymphoma Treatment: A Multicenter Prospective Non-Randomized Controlled Study
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| AIDS-related Lymphoma | AIDS-Related Lymphoma | ONTOLOGY_EXACT | 0.98 |
| HIV Infection | — | UNRESOLVED | — |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| albuvirtide | Drug | — | UNRESOLVED |
| Cabotegravir/Rilpivirine | Drug | — | UNRESOLVED |
| Oral Antiretroviral Therapy | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- OTHER
- label
- Oral ART
- description
- Participants will receive standard oral antiretroviral therapy throughout lymphoma treatment.
- interventionNames
- Drug: Oral Antiretroviral Therapy
- type
- OTHER
- label
- Oral ART Plus Albuvirtide
- description
- Participants with viremia who agree to receive long-acting therapy will receive oral ART combined with intravenous albuvirtide.
- interventionNames
- Drug: Oral Antiretroviral Therapy
- Drug: albuvirtide
- type
- OTHER
- label
- Long-Acting Cabotegravir/Rilpivirine
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (2)
- RESULTSax 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
- RESULTFu 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