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NCT Number: NCT07727642

Optimization of Antiretroviral Therapy in Patients With AIDS-Related Lymphoma

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.

Recruiting

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Key information

Conditions

AIDS-related Lymphoma Blood-Borne Infections Communicable Diseases Genital Diseases HIV Infection HIV Infections Hemic and Lymphatic Diseases Immune System Diseases Immunologic Deficiency Syndromes Immunoproliferative Disorders Infections Lentivirus Infections Lymphatic Diseases Lymphoma Lymphoma, AIDS-Related Lymphoma, B-Cell Lymphoma, Non-Hodgkin Lymphoproliferative Disorders Neoplasms Neoplasms by Histologic Type RNA Virus Infections Retroviridae Infections Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Urogenital Diseases Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Shanghai Public Health Clinical Center

Shanghai, Shanghai Municipality, 201508, China

Location status: Recruiting

Location contact

Zhenyan Wang

CONTACT

[email protected]

+86021-37990333-3222

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Oral Antiretroviral Therapy

Drug

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

or

Current Oral ART Regimen at lymphoma diagnosis

Albuvirtide

Drug

Albuvirtide 640 mg intravenously every 4 weeks for five doses.

Cabotegravir/Rilpivirine

Drug

long-acting intramuscular cabotegravir and rilpivirine according to the approved dosing schedule.

Primary outcomes

  1. Virological Suppression Rate at Week 24

    Time frame: Week 24

    Percentage of participants achieving plasma HIV RNA <50 copies/mL at Week 24.

Secondary outcomes

  1. CD4 Cell Count Change

    Time frame: Week 24 Week 48

    Change from baseline in CD4+ T-cell count.

  2. Low-Level Viremia

    Time frame: Week 24 and Week 48

    Percentage of participants with HIV RNA between 50 and 200 copies/mL.

  3. Virological Failure

    Time frame: Week 24

    Percentage of participants with HIV RNA ≥200 copies/mL.

  4. Adverse Events

    Time frame: Baseline through Week 48

    Incidence of adverse events and serious adverse events.

  5. Virological Suppression Rate at Week 48

    Time frame: Week 48.

    Percentage of participants achieving plasma HIV RNA <50 copies/mL at Week 48.

Study contacts

Contact information is provided by the study sponsor or research team.

Zhenyan Wang

CONTACT

[email protected]

+86021-37990333-3222

Sponsors and collaborators

Lead sponsor

Shanghai Public Health Clinical Center

Other Gov

Registry information

Official study title

Optimization of Antiretroviral Therapy in Patients With AIDS-Related Lymphoma During Anti-Lymphoma Treatment: A Multicenter Prospective Non-Randomized Controlled Study

Acronym: OPT-ARL

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Jul 27, 2026
Registry last updated
Jul 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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