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Immunomodulators on HIV-1 Reservoir

Primary Purpose

HIV Infections

Status

Recruiting

Phase

Phase 4

Locations

China

Study Type

Interventional

Intervention

Lenalidomide

Adenosylmethionine

About this trial

This is an interventional treatment trial for HIV Infections

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

the first affiliated hospital of Zhejiang university school of medicineRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

No Intervention

Arm Label

Lenalidomide

Adenosylmethionine

Control

Arm Description

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.

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.

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

Outcomes

Primary Outcome Measures

HIV reservoirs

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

Decreased inflammatory factors in HIV-infected patients

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

Secondary Outcome Measures

T-cell subsets

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

Immune activation

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

Gut microbiome

Diversity and composition of gut microbiome.

Tolerability and safety outcomes

Discontinuation and occurrence of adverse event.

Full Information

NCT ID

NCT05598580

First Posted

October 26, 2022

Last Updated

September 12, 2023

Sponsor

First Affiliated Hospital of Zhejiang University

1. Study Identification

Unique Protocol Identification Number

NCT05598580

Brief Title

Immunomodulators on HIV-1 Reservoir

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

October 2022

Overall Recruitment Status

Recruiting

Study Start Date

November 20, 2022 (Actual)

Primary Completion Date

May 2024 (Anticipated)

Study Completion Date

November 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

First Affiliated Hospital of Zhejiang University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Data Monitoring Committee

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

HIV Infections

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

48 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Lenalidomide

Arm Type

Experimental

Arm Description

Arm Title

Adenosylmethionine

Arm Type

Experimental

Arm Description

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.

Arm Title

Control

Arm Type

No Intervention

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

Lenalidomide

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Adenosylmethionine

Intervention Description

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

Primary Outcome Measure Information:

Title

HIV reservoirs

Description

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

Time Frame

48 weeks

Title

Decreased inflammatory factors in HIV-infected patients

Description

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

Time Frame

48 weeks

Secondary Outcome Measure Information:

Title

T-cell subsets

Description

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

Time Frame

48 weeks

Title

Immune activation

Description

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

Time Frame

48 weeks

Title

Gut microbiome

Description

Diversity and composition of gut microbiome.

Time Frame

48 weeks

Title

Tolerability and safety outcomes

Description

Discontinuation and occurrence of adverse event.

Time Frame

48 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Biao Zhu

Phone

+86-0571-87236437

zhubiao1327@zju.edu.cn

First Name & Middle Initial & Last Name or Official Title & Degree

Xiaorong Peng

Phone

+86-0571-87236417

699xiaorong@163.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Biao Zhu

Organizational Affiliation

Zhejiang University

Official's Role

Principal Investigator

Facility Information:

Facility Name

the first affiliated hospital of Zhejiang university school of medicine

City

Hangzhou

State/Province

Zhejiang

ZIP/Postal Code

310000

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Xiaorong Peng, MD

Phone

15158843398

699xiaorong@163.com

12. IPD Sharing Statement

Plan to Share IPD

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Immunomodulators on HIV-1 Reservoir

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