HIV InfectionsPhase 4NCT05598580
Immunomodulators on HIV-1 Reservoir
A Phase 4 study testing Lenalidomide and Adenosylmethionine in people with HIV Infections, run by First Affiliated Hospital of Zhejiang University at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- HIV Infections
- What is being tested?
- Lenalidomide and Adenosylmethionine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteChina
- Study dates
- 20 Nov 2022to Nov 2024
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
the first affiliated hospital of Zhejiang university school of medicine
Hangzhou, Zhejiang, 310000
Xiaorong Peng, MD, 15158843398, 699xiaorong@163.com
About this study
Official title: Functional Cure Strategy and Clinical Study of AIDS--Study on the Reduction of HIV Viral Reservoir by Immunomodulators (IMs)
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.
- Conditions
- HIV Infections
- Being tested
- Lenalidomide, Adenosylmethionine
- Medical subject headings
- HIV Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LenalidomideDrug
Lenalidomide capsules (25 mg) were administered orally on days 1-21 of a 28-day cycle for 24 weeks with continuous antiretroviral therapy.
AdenosylmethionineDrug
Adenosylmethionine capsules (1000 mg, twice a day) were administered orally for 24 weeks with continuous antiretroviral therapy.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Lenalidomide |
| 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. Receives: Drug: Adenosylmethionine |
| Control | No intervention | Participants will continue to receive antiretroviral therapy without other intervention and be monitored for 48 weeks. |
What is being measured
The primary outcome is the main question the study is designed to answer.
HIV reservoirs
The size of the HIV reservoir in blood determined by HIV-DNA and CA-HIV-RNA.
Measured: 48 weeks
Decreased inflammatory factors in HIV-infected patients
The following inflammatory cytokines: interferon-alpha (IFN-α), TNF-α, IL-1, IL-6.
Measured: 48 weeks
Secondary outcomes (4)
T-cell subsets
Absolute CD4+ and CD8+ T-cell counts and CD4/CD8 ratio were measured on peripheral blood mononuclear cells.
Measured: 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.
Measured: 48 weeks
Gut microbiome
Diversity and composition of gut microbiome.
Measured: 48 weeks
Tolerability and safety outcomes
Discontinuation and occurrence of adverse event.
Measured: 48 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2022
- Study start20 Nov 2022
- Primary completionMay 2024 (estimated)
- Study completionNov 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIV InfectionsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 48 participants (estimated)
Sponsor and investigators
- Lead sponsor
- First Affiliated Hospital of Zhejiang University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Biao Zhu, Principal investigator, Zhejiang University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05598580
- Sponsor's protocol ID
- 2022IMs
- Status last verified
- Oct 2022
- First submitted
- 26 Oct 2022
- Last updated
- 14 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Functional Cure Strategy and Clinical Study of AIDS--Study on the Reduction of HIV Viral Reservoir by Immunomodulators (IMs)
- ClinicalTrials.gov ID
- NCT05598580
- Acronym / sponsor ID
- 2022IMs
- Conditions
- HIV Infections
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- First Affiliated Hospital of Zhejiang UniversityUniversity, hospital or other
- Study start
- 20 Nov 2022 (actual)
- Primary completion
- May 2024 (estimated)
- Study completion
- Nov 2024 (estimated)
- First posted
- 28 Oct 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Lenalidomide | Experimental | Drug: LenalidomideLenalidomide 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 | Drug: AdenosylmethionineAdenosylmethionine 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LenalidomideLenalidomide capsules (25 mg) were administered orally on days 1-21 of a 28-day cycle for 24 weeks with continuous antiretroviral therapy. | Drug | Lenalidomide |
| AdenosylmethionineAdenosylmethionine capsules (1000 mg, twice a day) were administered orally for 24 weeks with continuous antiretroviral therapy. | Drug | Adenosylmethionine |
Primary outcome
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.
4 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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Sep 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Biao Zhu principal investigator
Zhejiang University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Lenalidomide and Adenosylmethionine in people with HIV Infections, run by First Affiliated Hospital of Zhejiang University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 14 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Biao Zhu (+86-0571-87236437, zhubiao1327@zju.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
HIV reservoirs (time frame: 48 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Sep 2023.