Functional Cure Strategy and Clinical Study of AIDS--Study on the Reduction of HIV Viral Reservoir by Immunomodulators (IMs)

First Affiliated Hospital of Zhejiang University1 site in 1 country48 target enrollmentNovember 20, 2022

ConditionsHIV Infections

InterventionsLenalidomide Adenosylmethionine

DrugsLenalidomide Adenosylmethionine

Overview

Phase: Phase 4
Intervention: Lenalidomide
Conditions: HIV Infections
Sponsor: First Affiliated Hospital of Zhejiang University
Enrollment: 48
Locations: 1
Primary Endpoint: Decreased inflammatory factors in HIV-infected patients
Status: Recruiting
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

The goal of this clinical trial is to learn about the function of immunomodulators in reducing HIV reservoir. The main questions it aims to answer are:

Are immunomodulators able to reduce HIV reservoirs?
How do immunomodulators reduce HIV reservoirs? Participants will be randomly and equally divided into three groups, one control group and two trial groups. All three groups will continue to receive antiretroviral therapy. The two experimental groups will additionally be given different immunomodulators lenalidomide and adenosylmethionine, respectively. The effectiveness of immunomodulatory agents in reducing viral reservoirs will be explored by comparing relevant indicators in the three groups.

Registry

clinicaltrials.gov

Start Date

November 20, 2022

End Date

November 2024

Last Updated

2 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

First Affiliated Hospital of Zhejiang University

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Men and women age ≥ 18 and ≤ 65 years.
•HIV-1 infection, confirmed by any licensed rapid HIV test and then a licensed Western blot.
•Virologic suppression defined as HIV-1 RNA level below the limit of quantification prior to study entry.
•CD4+ T cell count \> 200 cells/mm3 prior to study entry.
•Ability and willingness of participant or legal representative to provide written informed consent and attend study visits as scheduled at a participating site. Willingness of participant to accept the side effects of drugs.
•All participants of reproductive potential, who are participating in sexual activity that could lead to pregnancy, must agree to use at least one reliable method of contraception from 4 weeks before the start of the study to 4 weeks after the end of the study.

Exclusion Criteria

•Breastfeeding or pregnancy, or planned pregnancy during the study.
•Poor treatment adherence.
•Use of immunomodulators or systemic cytotoxic chemotherapy ≤ 6 months prior to study entry.
•Any current diagnosis or past history of a significant cardiovascular, respiratory, hepatic, gastrointestinal, endocrine, hematological, neurological, neuropsychiatric, psychiatric, or other serious illness. The following laboratory values obtained prior to entry:
•Absolute neutrophil count (ANC) ≤ 1000/mm3
•Platelets ≤ 75,000/mm3
•Known allergy/sensitivity or any hypersensitivity to components of study drug or their formulation.
•Unwilling to provide written informed consent.

Arms & Interventions

Lenalidomide

Lenalidomide capsules (25 mg) were administered orally on days 1-21 of a 28-day cycle for 24 weeks with continuous antiretroviral therapy. After that, participants will be monitored for another 24 weeks.

Intervention: Lenalidomide

Adenosylmethionine

Adenosylmethionine capsules (1000 mg, twice a day) were administered orally for 24 weeks with continuous antiretroviral therapy. After that, participants will be monitored for another 24 weeks.

Intervention: Adenosylmethionine