HIV Infections
Conditions
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.
Interventions
DRUGLenalidomide
Lenalidomide capsules (25 mg) were administered orally on days 1-21 of a 28-day cycle for 24 weeks with continuous antiretroviral therapy.
DRUGAdenosylmethionine
Adenosylmethionine capsules (1000 mg, twice a day) were administered orally for 24 weeks with continuous antiretroviral therapy.
Sponsors
First Affiliated Hospital of Zhejiang University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| HIV reservoirs | 48 weeks | The size of the HIV reservoir in blood determined by HIV-DNA and CA-HIV-RNA. |
| Decreased inflammatory factors in HIV-infected patients | 48 weeks | The following inflammatory cytokines: interferon-alpha (IFN-α), TNF-α, IL-1, IL-6. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| T-cell subsets | 48 weeks | Absolute CD4+ and CD8+ T-cell counts and CD4/CD8 ratio were measured on peripheral blood mononuclear cells. |
| 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. |
| Gut microbiome | 48 weeks | Diversity and composition of gut microbiome. |
| Tolerability and safety outcomes | 48 weeks | Discontinuation and occurrence of adverse event. |
Countries
China
Contacts
Primary ContactBiao Zhu
Backup ContactXiaorong Peng
Outcome results
None listed