Immunomodulators on HIV-1 Reservoir

NCT05598580 | Unknown Phase 4

• 1 other identifier: 2022IMs
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

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.

Conditions

HIV Infections

Outcome Measures

Primary Outcomes (2)

• HIV reservoirs

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

  48 weeks

• Decreased inflammatory factors in HIV-infected patients

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

  48 weeks

Secondary Outcomes (4)

• T-cell subsets

  48 weeks

• Immune activation

  48 weeks

• Gut microbiome

  48 weeks

• Tolerability and safety outcomes

  48 weeks

Study Arms (3)

Lenalidomide

EXPERIMENTAL

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

Adenosylmethionine

EXPERIMENTAL

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

Control

NO INTERVENTION

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

Interventions

Lenalidomide DRUG

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

Lenalidomide

Adenosylmethionine DRUG

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

Adenosylmethionine

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• First Affiliated Hospital of Zhejiang University: lead

Study Sites (1)

the first affiliated hospital of Zhejiang university school of medicine

Hangzhou, Zhejiang, 310000, China

RECRUITING

MeSH Terms

Conditions

HIV Infections

Interventions

Lenalidomide

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Intervention Hierarchy (Ancestors)

Phthalimides; Phthalic Acids; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Piperidones; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Isoindoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Biao Zhu

  Zhejiang University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Biao Zhu

CONTACT

+86-0571-87236437; zhubiao1327@zju.edu.cn

Xiaorong Peng

CONTACT

+86-0571-87236417; 699xiaorong@163.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 26, 2022
• First Posted: October 28, 2022
• Study Start: November 20, 2022
• Primary Completion: May 1, 2024
• Study Completion: November 1, 2024
• Last Updated: September 14, 2023

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)