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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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| Control | No Intervention | Participants will continue to receive antiretroviral therapy without other intervention and be monitored for 48 weeks. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| T-cell subsets | Absolute CD4+ and CD8+ T-cell counts and CD4/CD8 ratio were measured on peripheral blood mononuclear cells. | 48 weeks |
| Immune activation | Immune activation measured by the percentage of human leukocyte antigen-DR isotype (HLA-DR) and CD38 expressing T-cells in blood. |
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Inclusion Criteria:
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:
Known allergy/sensitivity or any hypersensitivity to components of study drug or their formulation.
Unwilling to provide written informed consent.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Biao Zhu | Contact | +86-0571-87236437 | zhubiao1327@zju.edu.cn | |
| Xiaorong Peng | Contact | +86-0571-87236417 | 699xiaorong@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Biao Zhu | Zhejiang University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| the first affiliated hospital of Zhejiang university school of medicine | Recruiting | Hangzhou | Zhejiang | 310000 | China |
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| ID | Term |
|---|---|
| D015658 | HIV Infections |
| ID | Term |
|---|---|
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D015229 | Sexually Transmitted Diseases, Viral |
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| ID | Term |
|---|---|
| D000077269 | Lenalidomide |
| ID | Term |
|---|---|
| D010797 | Phthalimides |
| D010795 | Phthalic Acids |
| D000146 | Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
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| Adenosylmethionine | Drug | Adenosylmethionine capsules (1000 mg, twice a day) were administered orally for 24 weeks with continuous antiretroviral therapy. |
|
| 48 weeks |
| Gut microbiome | Diversity and composition of gut microbiome. | 48 weeks |
| Tolerability and safety outcomes | Discontinuation and occurrence of adverse event. | 48 weeks |
| D012749 | Sexually Transmitted Diseases |
| D016180 | Lentivirus Infections |
| D012192 | Retroviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D007153 | Immunologic Deficiency Syndromes |
| D007154 | Immune System Diseases |
| D009930 |
| Organic Chemicals |
| D010881 | Piperidones |
| D010880 | Piperidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D054833 | Isoindoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |