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Optimization of Antiretroviral Therapy in Patients With AIDS-Related Lymphoma

NCT07727642 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2026-07-27

No results posted yet for this study

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. 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

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.

Sponsors & Collaborators

  • Shanghai Public Health Clinical Center

    lead OTHER_GOV

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-05-26
Primary Completion
2028-07-31
Completion
2028-07-31

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07727642 on ClinicalTrials.gov