HIV-1-infectionEarly Phase 1NCT04963712
Zadaxin and HIV-positive Patients With Immune Reconstitution Disorder
A Early Phase 1 study testing Zadaxin in people with HIV-1-infection, run by Shanghai Public Health Clinical Center at 1 site in China.
Trial summary
The purpose of this study is to evaluate the safety and efficacy of Zadaxin® in the treatment of HIV-positive patients with immune reconstitution disorders. Researchers previously used Zadaxin® (Thymosin α-1, Tα1) as an immune adjuvant for people infected with HIV-1 and found that Tα1 and Interferon-α (IFN-α) have a… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- HIV-1-infection
- What is being tested?
- Zadaxin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteChina
- Study dates
- 1 Sep 2021to 11 Aug 2022
- Phase
- Early Phase 1
- 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
- Age 18-65 years old;
- HIV serology is positive;
- Volunteer to participate;
- CD4+T cell count >100 and <350 cells/mm3;
- People who have received HAART treatment and the viral load is undetected for at least 2 years, but have immune reconstitution disorder;
- Without active opportunistic infection;
Who cannot join
- History of allergy or contraindications to Zadaxin;
- Skin basal cell carcinoma, cervical carcinoma in situ or other concurrent tumors other than Kaposi's sarcoma;
- The expected survival time is less than 1 year;
- Women of childbearing age have a positive pregnancy test;
- Major heart disease or central nervous system disease or other nervous system abnormalities;
- ACTG-AIDS dementia syndrome staging score> 0.5;
Show all 14Show fewer
- Organ transplantation;
- Received chemotherapy and radiotherapy for malignant tumors within 6 months;
- Known immunomodulators (such as systemic steroids, interferons, interleukins) or other immunotherapy within 30 days before the start of the study;
- Blood transfusion within 30 days before the start of the study;
- Have a history of iritis, endophthalmitis, scleritis or retinitis;
- Within 30 days before the screening assessment, accept any experimental treatment for HIV-positive patients with or without symptoms of infection;
- Drug abuse;
- The doctor's decision is that participation in the trial is not in the patient's best interests, or any situation that does not allow safe compliance with the protocol.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Prospective Single-arm Cohort Study Evaluating the Safety and Efficacy of Thymalfasin (Zadaxin®) in the Treatment of HIV-positive Patients With Immune Reconstitution Disorders
The purpose of this study is to evaluate the safety and efficacy of Zadaxin® in the treatment of HIV-positive patients with immune reconstitution disorders. Researchers previously used Zadaxin® (Thymosin α-1, Tα1) as an immune adjuvant for people infected with HIV-1 and found that Tα1 and Interferon-α (IFN-α) have a synergistic effect in immune enhancement. In addition, studies have found that the triple combination of Tα1, IFN-α and Zidovudine has better tolerability, safety and efficacy. After treatment, patients have lower HIV RNA and more stable high CD4+ T cell counts. In addition, extensive studies on the administration of Tα1 in thymectomized mice have demonstrated its ability to promote immune reconstitution. The researchers hypothesized that Zadaxin® has a better therapeutic effect on HIV-positive patients with immune reconstitution disorders, can increase the CD4+T cell count, reduce the viral load, and has better safety.
Read the detailed description
All patients received Zadaxin (1.6 mg subcutaneous injection, once a day) in the first 2 weeks, and changed frequency (1.6 mg subcutaneous injection, twice a week) in the successive 22 weeks. It is still recommended to continue treatment until the end of the study. All subjects were given HAART treatment throughout. In 4th week, 8th week, 12th week and 24th week, perform 4 follow-up and record the changes in CD4+ T cell count and proportion, CD8+ T cell count and proportion, proportions of T cell subsets, PBMC sjTREC, proportions of exhauseted T cell expressed PD-1 and Tim-3, and HIV viral load. During the process, safety assessment is performed, including adverse events, electrocardiogram and a series of laboratory tests (blood routine, liver and kidney function, etc.).
- Conditions
- HIV-1-infection
- Being tested
- Zadaxin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ZadaxinDrug
Also called Thymosin α1
1.6 mg subcutaneous injection, once a day in the first 2 weeks, and 1.6 mg subcutaneous injection, twice a week in the successive 22 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Zadaxin-HIV(n=20) | Experimental | Study participants will be given Zadaxin (1.6 mg subcutaneous injection, once a day) in the first 2 weeks, and changed frequency (1.6 mg subcutaneous injection, twice a week) in the successive 22 weeks. Receives: Drug: Zadaxin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in CD4+T cell counts
Peripheral blood
Measured: Measured on week 24
Change in CD4/CD8 ratio
Peripheral blood
Measured: Measured on week 24
Secondary outcomes (6)
Change in CD4+T cell count and proportion
Peripheral blood
Measured: Measured on week 0, 4, 8, 12, 24
Change in CD8+T cell count and proportion
Peripheral blood
Measured: Measured on week 0, 4, 8, 12, 24
Change in proportions of T cell subsets
Peripheral blood mononuclear cell
Measured: Measured on week 0, 4, 8, 12, 24
Change in proportions of immune exhausted T cells expressed PD-1 and TIM-3
Peripheral blood mononuclear cell
Measured: Measured on week 0, 4, 8, 12, 24
Change in PBMC sjTREC
Peripheral blood mononuclear cell
Measured: Measured on week 0, 4, 8, 12, 24
Change in HIV-1 RNA
Plasma
Measured: Measured on week 0, 4, 8, 12, 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2021
- Study start1 Sep 2021
- Primary completion22 Jul 2022
- Study completion11 Aug 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HIV-1-infectionStudies 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
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- All participants eligible for study received the same open label drug
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shanghai Public Health Clinical Center
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Hongzhou Lu, Shanghai Public Health Clinical Center
- Investigators
- Hongzhou Lu, Ph.D, Study director, Shanghai Public Health Clinical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04963712
- Sponsor's protocol ID
- Zadaxin-HIV
- Status last verified
- Jul 2023
- First submitted
- 7 Jul 2021
- Last updated
- 18 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Chen C, Wang J, Xun J, Zhang X, Liu L, Song Z, Zhang R, Chen J, Lu H. Role of thymosin alpha1 in restoring immune response in immunological nonresponders living with HIV. BMC Infect Dis. 2024 Jan 17;24(1):97. doi: 10.1186/s12879-024-08985-y.
PubMed 38233816
Study at a glance
From the registry record, last updated by the sponsor on 18 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Single-arm Cohort Study Evaluating the Safety and Efficacy of Thymalfasin (Zadaxin®) in the Treatment of HIV-positive Patients With Immune Reconstitution Disorders
- ClinicalTrials.gov ID
- NCT04963712
- Acronym / sponsor ID
- Zadaxin-HIV
- Conditions
- HIV-1-infection
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Shanghai Public Health Clinical CenterOther government
- Study start
- 1 Sep 2021 (actual)
- Primary completion
- 22 Jul 2022 (actual)
- Study completion
- 11 Aug 2022 (actual)
- First posted
- 15 Jul 2021 (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 purpose of this study is to evaluate the safety and efficacy of Zadaxin® in the treatment of HIV-positive patients with immune reconstitution disorders. Researchers previously used Zadaxin® (Thymosin α-1, Tα1) as an immune adjuvant for people infected with HIV-1 and found that Tα1 and Interferon-α (IFN-α) have a synergistic effect in immune enhancement. In addition, studies have found that the triple combination of Tα1, IFN-α and Zidovudine has better tolerability, safety and efficacy. After treatment, patients have lower HIV RNA and more stable high CD4+ T cell counts. In addition, extensive studies on the administration of Tα1 in thymectomized mice have demonstrated its ability to promote immune reconstitution. The researchers hypothesized that Zadaxin® has a better therapeutic effect on HIV-positive patients with immune reconstitution disorders, can increase the CD4+T cell count, reduce the viral load, and has better safety.
Detailed description
All patients received Zadaxin (1.6 mg subcutaneous injection, once a day) in the first 2 weeks, and changed frequency (1.6 mg subcutaneous injection, twice a week) in the successive 22 weeks. It is still recommended to continue treatment until the end of the study. All subjects were given HAART treatment throughout. In 4th week, 8th week, 12th week and 24th week, perform 4 follow-up and record the changes in CD4+ T cell count and proportion, CD8+ T cell count and proportion, proportions of T cell subsets, PBMC sjTREC, proportions of exhauseted T cell expressed PD-1 and Tim-3, and HIV viral load. During the process, safety assessment is performed, including adverse events, electrocardiogram and a series of laboratory tests (blood routine, liver and kidney function, etc.).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- All participants eligible for study received the same open label drug
| Arm | Type | Receives |
|---|---|---|
| Zadaxin-HIV(n=20) | Experimental | Drug: ZadaxinStudy participants will be given Zadaxin (1.6 mg subcutaneous injection, once a day) in the first 2 weeks, and changed frequency (1.6 mg subcutaneous injection, twice a week) in the successive 22 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)
- Age 18-65 years old;
- HIV serology is positive;
- Volunteer to participate;
- CD4+T cell count >100 and <350 cells/mm3;
- People who have received HAART treatment and the viral load is undetected for at least 2 years, but have immune reconstitution disorder;
Key exclusion criteria (14 listed)
- History of allergy or contraindications to Zadaxin;
- Skin basal cell carcinoma, cervical carcinoma in situ or other concurrent tumors other than Kaposi's sarcoma;
- The expected survival time is less than 1 year;
- Women of childbearing age have a positive pregnancy test;
- Major heart disease or central nervous system disease or other nervous system abnormalities;
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 |
|---|---|---|
| ZadaxinAlso: Thymosin α11.6 mg subcutaneous injection, once a day in the first 2 weeks, and 1.6 mg subcutaneous injection, twice a week in the successive 22 weeks. | Drug | Zadaxin-HIV(n=20) |
Primary outcome
Change in CD4+T cell counts
Time frame: Measured on week 24
Peripheral blood
Change in CD4/CD8 ratio
Time frame: Measured on week 24
Peripheral blood
6 secondary outcomes
Change in CD4+T cell count and proportion
Time frame: Measured on week 0, 4, 8, 12, 24
Change in CD8+T cell count and proportion
Time frame: Measured on week 0, 4, 8, 12, 24
Change in proportions of T cell subsets
Time frame: Measured on week 0, 4, 8, 12, 24
Change in proportions of immune exhausted T cells expressed PD-1 and TIM-3
Time frame: Measured on week 0, 4, 8, 12, 24
Change in PBMC sjTREC
Time frame: Measured on week 0, 4, 8, 12, 24
Change in HIV-1 RNA
Time frame: Measured on week 0, 4, 8, 12, 24
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jul 2023.
- Derived from this study: PubMed 38233816Chen C, Wang J, Xun J, Zhang X, Liu L, Song Z, Zhang R, Chen J, Lu H. Role of thymosin alpha1 in restoring immune response in immunological nonresponders living with HIV. BMC Infect Dis. 2024 Jan 17;24(1):97. doi: 10.1186/s12879-024-08985-y.
- Individual participant dataSharing planned: No
Related trials for HIV-1-infection
RecruitingPhase 4
A Study to Provide Continued Access to Study Drug to Children and Adolescents Who Have Completed Clinical Studies Involving Gilead HIV Treatments
HIV-1-infection
Not yet recruitingPhase 4
NOTRE: Optimizing Long-Acting Pre-Exposure Prophylaxis and Medications for Opioid Use Disorder Interventions in Carceral Settings
HIV Infections, Opioid Use Disorder
Enrolling by invitation
Effect of Omega-3 Supplementation on Pregnant Outcomes and Inflammation Markers of Women Infected With HIV Using Antiretroviral Therapy
Pregnant HIV Positive Women
Not yet recruiting
HealthMpowerment Korea: Pilot Testing the Cultural Adaptation of a Digital HIV Intervention for Men Who Have Sex With Men in South Korea
HIV Infections, HIV Prevention and Care
Not yet recruiting
HC-HMP: Healthy Choices Implementation Trial
Alcohol Drinking, HIV Infections
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.
Hongzhou Lu, Ph.D study director
Shanghai Public Health Clinical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Zadaxin in people with HIV-1-infection, run by Shanghai Public Health Clinical Center 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 14 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: finished, as of the sponsor's last update on 18 Jul 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?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in CD4+T cell counts (time frame: Measured on week 24). 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?
On the ClinicalTrials.gov record for NCT04963712, which also lists 1 linked publication.
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 18 Jul 2023; AzTrials last refreshed its copy on 8 Nov 2026.