Clinical trial NCT05598580: 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
Overall status: UNKNOWN
Phase: PHASE4
Conditions: HIV Infections
Lead sponsor: First Affiliated Hospital of Zhejiang University
Sponsor class: OTHER
First posted: 2022-10-28
Enrollment: 48
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: HIV reservoirs
timeFrame: 48 weeks
measure: Decreased inflammatory factors in HIV-infected patients
timeFrame: 48 weeks
Secondary outcomes:
measure: T-cell subsets
timeFrame: 48 weeks
measure: Immune activation
timeFrame: 48 weeks
measure: Gut microbiome
timeFrame: 48 weeks
measure: Tolerability and safety outcomes
timeFrame: 48 weeks
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: the first affiliated hospital of Zhejiang university school of medicine
state: Zhejiang
Study officials:
affiliation: Zhejiang University
name: Biao Zhu
role: PRINCIPAL_INVESTIGATOR
References: