Immunomodulators on HIV-1 Reservoir

Zhejiang University

Status and phase: Enrolling; Phase 4

Conditions: HIV Infections

Treatments: Drug: Lenalidomide; Drug: Adenosylmethionine

Study type: Interventional

Funder types: Other

Identifiers

NCT05598580

2022IMs

Details and patient eligibility

About

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.

Enrollment: 48 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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48 participants in 3 patient groups

Lenalidomide

Experimental group

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.

Treatment:

Drug: Lenalidomide

Adenosylmethionine

Experimental group

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.

Treatment:

Drug: Adenosylmethionine

Control

No Intervention group

Description:

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