---
title: Immunomodulators on HIV-1 Reservoir
nct_id: NCT05598580
overall_status: UNKNOWN
phase: PHASE4
sponsor: First Affiliated Hospital of Zhejiang University
study_type: INTERVENTIONAL
primary_condition: HIV Infections
countries: China
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT05598580.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT05598580"
ct_last_update_post_date: 2023-09-14
last_seen_at: "2026-05-12T06:58:50.485Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# 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)

**NCT ID:** [NCT05598580](https://clinicaltrials.gov/study/NCT05598580)

## Key Facts

- **Status:** UNKNOWN
- **Phase:** PHASE4
- **Study Type:** INTERVENTIONAL
- **Target Enrollment:** 48
- **Lead Sponsor:** First Affiliated Hospital of Zhejiang University
- **Conditions:** HIV Infections
- **Start Date:** 2022-11-20
- **Completion Date:** 2024-11
- **CT.gov Last Update:** 2023-09-14

## 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

- **Minimum age:** 18 Years
- **Maximum age:** 65 Years
- **Sex:** ALL
- **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.
```

## Arms

- **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.

## Interventions

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

## Primary Outcomes

- **HIV reservoirs** _(time frame: 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** _(time frame: 48 weeks)_ — The following inflammatory cytokines: interferon-alpha (IFN-α), TNF-α, IL-1, IL-6.

## Secondary Outcomes

- **T-cell subsets** _(time frame: 48 weeks)_
- **Immune activation** _(time frame: 48 weeks)_
- **Gut microbiome** _(time frame: 48 weeks)_
- **Tolerability and safety outcomes** _(time frame: 48 weeks)_

## Locations (1)

- the first affiliated hospital of Zhejiang university school of medicine, Hangzhou, Zhejiang, China — _RECRUITING_

## Recent Field Changes (last 30 days)

- `status.overallStatus` — added _(2026-05-12)_
- `status.primaryCompletionDate` — added _(2026-05-12)_
- `status.completionDate` — added _(2026-05-12)_
- `status.lastUpdatePostDate` — added _(2026-05-12)_
- `design.phases` — added _(2026-05-12)_
- `design.enrollmentCount` — added _(2026-05-12)_
- `eligibility.criteria` — added _(2026-05-12)_
- `eligibility.minAge` — added _(2026-05-12)_
- `eligibility.maxAge` — added _(2026-05-12)_
- `eligibility.sex` — added _(2026-05-12)_
- `outcomes.primary` — added _(2026-05-12)_
- `outcomes.secondary` — added _(2026-05-12)_
- `armsInterventions.arms` — added _(2026-05-12)_
- `armsInterventions.interventions` — added _(2026-05-12)_
- `sponsor.lead` — added _(2026-05-12)_
- `results.hasResults` — added _(2026-05-12)_
- `locations.the first affiliated hospital of zhejiang university school of medicine|hangzhou|zhejiang|china` — added _(2026-05-12)_

---

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