AIDS-related LymphomaOPT-ARLNCT07727642
Optimization of Antiretroviral Therapy in Patients With AIDS-Related Lymphoma
A study testing Oral Antiretroviral Therapy, albuvirtide and Cabotegravir/Rilpivirine in people with AIDS-related Lymphoma and HIV Infection, run by Shanghai Public Health Clinical Center at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- AIDS-related Lymphoma, HIV Infection
- What is being tested?
- Oral Antiretroviral Therapy, albuvirtide and Cabotegravir/Rilpivirine
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- 26 May 2026to Jul 2028
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥18 years. Confirmed HIV infection. Histologically confirmed AIDS-related lymphoma. Receiving anti-lymphoma treatment. Able and willing to provide written informed consent.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Shanghai Public Health Clinical Center
Shanghai, Shanghai Municipality, 201508
Zhenyan Wang, +86021-37990333-3222, wangzhenyan@shaphc.org
About this study
Official title: Optimization of Antiretroviral Therapy in Patients With AIDS-Related Lymphoma During Anti-Lymphoma Treatment: A Multicenter Prospective Non-Randomized Controlled Study
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?
Read more
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
- AIDS-related Lymphoma, HIV Infection
- Being tested
- Oral Antiretroviral Therapy, albuvirtide, Cabotegravir/Rilpivirine
- Keywords
- HIV, AIDS-Related Lymphoma, Antiretroviral Therapy, Albuvirtide, Cabotegravir, Rilpivirine, Long-Acting Injectable ART, Virological Suppression
- Medical subject headings
- Lymphoma, AIDS-Related, HIV Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oral Antiretroviral TherapyDrug
Bictegravir/Emtricitabine/Tenofovir Alafenamide (BIC/FTC/TAF)
or
Current Oral ART Regimen at lymphoma diagnosis
albuvirtideDrug
Albuvirtide 640 mg intravenously every 4 weeks for five doses.
Cabotegravir/RilpivirineDrug
long-acting intramuscular cabotegravir and rilpivirine according to the approved dosing schedule.
| Study group | Role | What they receive |
|---|---|---|
| Oral ART | Other | Participants will receive standard oral antiretroviral therapy throughout lymphoma treatment. Receives: Drug: Oral Antiretroviral Therapy |
| Oral ART Plus Albuvirtide | Other | Participants with viremia who agree to receive long-acting therapy will receive oral ART combined with intravenous albuvirtide. Receives: Drug: Oral Antiretroviral Therapy; Drug: albuvirtide |
| Long-Acting Cabotegravir/Rilpivirine | Other | Eligible participants will receive long-acting intramuscular cabotegravir and rilpivirine according to the approved dosing schedule. Receives: Drug: Cabotegravir/Rilpivirine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Virological Suppression Rate at Week 24
Percentage of participants achieving plasma HIV RNA <50 copies/mL at Week 24.
Measured: Week 24
Secondary outcomes (5)
CD4 Cell Count Change
Change from baseline in CD4+ T-cell count.
Measured: Week 24 Week 48
Low-Level Viremia
Percentage of participants with HIV RNA between 50 and 200 copies/mL.
Measured: Week 24 and Week 48
Virological Failure
Percentage of participants with HIV RNA ≥200 copies/mL.
Measured: Week 24
Adverse Events
Incidence of adverse events and serious adverse events.
Measured: Baseline through Week 48
Virological Suppression Rate at Week 48
Percentage of participants achieving plasma HIV RNA <50 copies/mL at Week 48.
Measured: Week 48.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2026
- Study start26 May 2026
- Primary completionJul 2028 (estimated)
- Study completionJul 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for AIDS-related LymphomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Public Health Clinical Center
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Zhenyan Wang, Shanghai Public Health Clinical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07727642
- Sponsor's protocol ID
- 2025-S128-04
- Acronym
- OPT-ARL
- Status last verified
- Jul 2026
- First submitted
- 22 Jul 2026
- Last updated
- 27 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 38427337Fu 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.
PubMed 41429707