Health TrialsbyHealthPanel

Optimization of Antiretroviral Therapy in Patients With AIDS-Related Lymphoma

ConditionsAIDS-related LymphomaHIV Infection
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorShanghai Public Health Clinical Center

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

None

Disqualifiers

None

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

Treatment groups

60 Participants
are divided into 3 treatment groups
Group A: Oral ARTOther 1 intervention
Group B: Oral ART Plus AlbuvirtideOther 2 interventions
Group C: Long-Acting Cabotegravir/RilpivirineOther 1 intervention

Trial outcomes

Primary outcomes

1

Virological Suppression Rate at Week 24

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

Time frame
Week 24

Secondary outcomes

1

CD4 Cell Count Change

Change from baseline in CD4+ T-cell count.

Time frame
Week 24 Week 48
2

Low-Level Viremia

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

Time frame
Week 24 and Week 48
3

Virological Failure

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

Time frame
Week 24
4

Adverse Events

Incidence of adverse events and serious adverse events.

Time frame
Baseline through Week 48

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Shanghai Public Health Clinical Center

Lead sponsor

Source ClinicalTrials.gov
Apply now