Optimization of Antiretroviral Therapy in Patients With AIDS-Related Lymphoma (OPT-ARL)

July 22, 2026 updated by: Zhenyan Wang, Shanghai Public Health Clinical Center

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?

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Shanghai Municipality
      • Shanghai, Shanghai Municipality, China, 201508
        • Recruiting
        • Shanghai Public Health Clinical Center
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Oral ART
Participants will receive standard oral antiretroviral therapy throughout lymphoma treatment.
Drug: Oral Antiretroviral Therapy

Bictegravir/Emtricitabine/Tenofovir Alafenamide (BIC/FTC/TAF)

or

Current Oral ART Regimen at lymphoma diagnosis
Other: Oral ART Plus Albuvirtide
Participants with viremia who agree to receive long-acting therapy will receive oral ART combined with intravenous albuvirtide.
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.
Other: Long-Acting Cabotegravir/Rilpivirine
Eligible participants will receive long-acting intramuscular cabotegravir and rilpivirine according to the approved dosing schedule.
Drug: Cabotegravir/Rilpivirine
long-acting intramuscular cabotegravir and rilpivirine according to the approved dosing schedule.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Virological Suppression Rate at Week 24
Time Frame: Week 24
Percentage of participants achieving plasma HIV RNA <50 copies/mL at Week 24.
Week 24

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
CD4 Cell Count Change
Time Frame: Week 24 Week 48
Change from baseline in CD4+ T-cell count.
Week 24 Week 48
Low-Level Viremia
Time Frame: Week 24 and Week 48
Percentage of participants with HIV RNA between 50 and 200 copies/mL.
Week 24 and Week 48
Virological Failure
Time Frame: Week 24
Percentage of participants with HIV RNA ≥200 copies/mL.
Week 24
Adverse Events
Time Frame: Baseline through Week 48
Incidence of adverse events and serious adverse events.
Baseline through Week 48
Virological Suppression Rate at Week 48
Time Frame: Week 48.
Percentage of participants achieving plasma HIV RNA <50 copies/mL at Week 48.
Week 48.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shanghai Public Health Clinical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 26, 2026

Primary Completion (Estimated)

July 1, 2028

Study Completion (Estimated)

July 1, 2028

Study Registration Dates

First Submitted

July 22, 2026

First Submitted That Met QC Criteria

July 22, 2026

First Posted (Actual)

July 27, 2026

Study Record Updates

Last Update Posted (Actual)

July 27, 2026

Last Update Submitted That Met QC Criteria

July 22, 2026

Last Verified

July 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2025-S128-04

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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