Immunomodulators on HIV-1 Reservoir

Sponsor
First Affiliated Hospital of Zhejiang University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05598580
Collaborator
(none)
48
3
24

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
Phase 4

Study Design

Study Type:
Interventional
Anticipated Enrollment :
48 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Functional Cure Strategy and Clinical Study of AIDS--Study on the Reduction of HIV Viral Reservoir by Immunomodulators (IMs)
Anticipated Study Start Date :
Nov 1, 2022
Anticipated Primary Completion Date :
May 1, 2024
Anticipated Study Completion Date :
Nov 1, 2024

Arms and Interventions

Arm Intervention/Treatment
Experimental: 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.

Drug: Lenalidomide
Lenalidomide capsules (25 mg) were administered orally on days 1-21 of a 28-day cycle for 24 weeks with continuous antiretroviral therapy.

Experimental: 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.

Drug: Adenosylmethionine
Adenosylmethionine capsules (1000 mg, twice a day) were administered orally for 24 weeks with continuous antiretroviral therapy.

No Intervention: Control

Participants will continue to receive antiretroviral therapy without other intervention and be monitored for 48 weeks.

Outcome Measures

Primary Outcome Measures

  1. HIV reservoirs [48 weeks]

    The size of the HIV reservoir in blood determined by HIV-DNA and CA-HIV-RNA.

  2. Decreased inflammatory factors in HIV-infected patients [48 weeks]

    The following inflammatory cytokines: interferon-alpha (IFN-α), TNF-α, IL-1, IL-6.

Secondary Outcome Measures

  1. T-cell subsets [48 weeks]

    Absolute CD4+ and CD8+ T-cell counts and CD4/CD8 ratio were measured on peripheral blood mononuclear cells.

  2. Immune activation [48 weeks]

    Immune activation measured by the percentage of human leukocyte antigen-DR isotype (HLA-DR) and CD38 expressing T-cells in blood.

  3. Gut microbiome [48 weeks]

    Diversity and composition of gut microbiome.

  4. Tolerability and safety outcomes [48 weeks]

    Discontinuation and occurrence of adverse event.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 65 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • First Affiliated Hospital of Zhejiang University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
First Affiliated Hospital of Zhejiang University
ClinicalTrials.gov Identifier:
NCT05598580
Other Study ID Numbers:
  • 2022IMs
First Posted:
Oct 28, 2022
Last Update Posted:
Oct 28, 2022
Last Verified:
Oct 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Product Manufactured in and Exported from the U.S.:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Oct 28, 2022