Immunomodulators on HIV-1 Reservoir

HIV Infections Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05598580
• Other study ID #: 2022IMs
• Status: Recruiting
• Phase: Phase 4
• Start date: November 20, 2022
• Est. completion date: November 2024

Study information

• Verified date: October 2022
• Source: First Affiliated Hospital of Zhejiang University
• Contact: Biao Zhu
• Phone: +86-0571-87236437
• Email: zhubiao1327[@]zju.edu.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 48
• Est. completion date: November 2024
• Est. primary completion date: May 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• HIV Infections

Intervention

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

Locations

Country	Name	City	State
China	the first affiliated hospital of Zhejiang university school of medicine	Hangzhou	Zhejiang

Sponsors (1)

Lead Sponsor	Collaborator
First Affiliated Hospital of Zhejiang University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	HIV reservoirs	The size of the HIV reservoir in blood determined by HIV-DNA and CA-HIV-RNA.	48 weeks
Primary	Decreased inflammatory factors in HIV-infected patients	The following inflammatory cytokines: interferon-alpha (IFN-a), TNF-a, IL-1, IL-6.	48 weeks
Secondary	T-cell subsets	Absolute CD4+ and CD8+ T-cell counts and CD4/CD8 ratio were measured on peripheral blood mononuclear cells.	48 weeks
Secondary	Immune activation	Immune activation measured by the percentage of human leukocyte antigen-DR isotype (HLA-DR) and CD38 expressing T-cells in blood.	48 weeks
Secondary	Gut microbiome	Diversity and composition of gut microbiome.	48 weeks
Secondary	Tolerability and safety outcomes	Discontinuation and occurrence of adverse event.	48 weeks