Chronic Abnormal Immune Activation in HIV/AIDSPhase 2NCT04084444
Safety and Efficacy of T8 on Treating Chronic Abnormal Immune Activation in HIV/AIDS Patients
A Phase 2 study testing T8 tablet 0.5mg and T8 tablet 1mg in people with Chronic Abnormal Immune Activation in HIV/AIDS, run by Shanghai Pharmaceuticals Holding Co., Ltd at 9 sites in China.
Trial summary
This is a multicenter, randomized, double-blind, dose-finding, placebo-controlled study in patients with chronic HIV infection and inadequate immune restoration treated with long-term highly active antiretroviral therapy (HAART). Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Chronic Abnormal Immune Activation in HIV/AIDS
- What is being tested?
- T8 tablet 0.5mg and T8 tablet 1mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 151 participants
- Where
- 9 sitesChina
- Study dates
- 25 Dec 2019to 5 Jul 2022
- Phase
- Phase 2
- 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
- Chinese subjects aged 18-65, male or female；
- Subjects with Body mass index (BMI) ≥18 (kg/m2); Male weight ≥50kg, female weight ≥45kg；
- Subjects must meet the criteria;
- No birth planning；
- Understand and sign informed consent form voluntarily.
Who cannot join
- allergic constitution；
- Pregnant or lactating women；
- Subjects who have been diagnosed with malignant tumors；
- Subjects whose laboratory tests meet the conditions；
- Subjects who have been diagnosed with severe gastrointestinal diseases；
- Subjects who have been diagnosed with severe cardiovascular disease；
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- Subjects who have been diagnosed with severe cerebrovascular disease；
- Subjects with history of alcohol and drug abuse；
- Subjects who have participated in any other clinical trial；
- Subjects who have any conditions that the investigator considers not suitable for this trial.
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
China9 sites
Peking Union Medical College Hospital
Beijing, Beijing Municipality, 100032
Beijing Dita Hospital, Capital Medical University
Beijing, Beijing Municipality
Beijing You An Hospital, Capital Medical University
Beijing, Beijing Municipality
The First Hospital of Changsha
Changsha, Hunan
Xixi Hospital of Hangzhou
Hangzhou, Zhejiang, 310023
The First Affiliated Hospital, Zhejiang University
Hangzhou, Zhejiang
Yun Provincial Infectious Disease Hospital
Kunming, Yunnan, 650399
The Second Hospital of Nanjing
Nanjing, Jiangsu
Tianjin Second People's Hospital
Tianjin
About this study
Official title: Efficacy and Safety of T8 on Treating Chronic Abnormal Immune Activation in HIV/AIDS Patients: A Multicenter, Randomized, Double-blind, Dose-finding, Placebo-controlled Study
This is a multicenter, randomized, double-blind, dose-finding, placebo-controlled study in patients with chronic HIV infection and inadequate immune restoration treated with long-term highly active antiretroviral therapy (HAART). A total of 150 eligible subjects will be selected and randomized at a ratio of 1:1:1 into T8 0.5 mg QD, 1 mg QD, and placebo group, with background HAART unchanged, for 48 consecutive weeks.
- Being tested
- T8 tablet 0.5mg, T8 tablet 1mg, Placebo
- Keywords
- Chronic abnormal immune activation, AIDS, T8, Efficacy, Safety
- Medical subject headings
- Acquired Immunodeficiency Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
T8 tablet 0.5mgDrug
Also called Leiteng Shu
Immune regulation, inhibition of acute nonspecific inflammation and chronic inflammation.
T8 tablet 1mgDrug
Also called Leiteng Shu
Immune regulation, inhibition of acute nonspecific inflammation and chronic inflammation.
PlaceboDrug
Blank control.
| Study group | Role | What they receive |
|---|---|---|
| T8 tablet 0.5mg | Experimental | Oral T8 tablet with HARRT, 0.5mg, once daily for 48 week Receives: Drug: T8 tablet 0.5mg |
| T8 tablet 1mg | Experimental | Oral T8 tablet with HARRT, 1mg, once daily for 48 week Receives: Drug: T8 tablet 1mg |
| Placebo | Placebo comparator | Oral Placebo with HARRT, once daily for 48 week Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
CD4+ T lymphocyte count
The changes of CD4+ T lymphocyte count from baseline
Measured: 48 week
The proportion of subjects whose CD4+ T lymphocyte count increased by≥50 /μL from baseline
The proportion of subjects whose CD4+ T lymphocyte count increased by≥50 /μL from baseline
Measured: 48 week
The changes of inflammatory factors
The quantitative changes of inflammatory factors（IP-10、hsCRP、IL-6）from baseline
Measured: 48 week
Secondary outcomes (4)
CD4+/CD8+T lymphocyte ratio
The changes of CD4+/CD8+T lymphocytes from baseline
Measured: 24 week and 48 week
The proportion of subjects whose CD4+ T lymphocyte count is increased by ≥20% from baseline
The proportion of subjects whose CD4+ T lymphocyte count is increased by ≥20% from baseline
Measured: 24 week and 48 week
The proportion of subjects whose CD4+ T lymphocyte count ≥ 200 /μL
The proportion of subjects whose CD4+ T lymphocyte count after treatment is≥200/μL, among subjects with CD4+T lymphocyte counts < 200/μL at baseline.
Measured: 24 week and 48 week
Incidence of AE and SAE
The incidence of AE and SAE
Measured: 24 week and 48 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2019
- Study start25 Dec 2019
- Primary completion5 Jul 2022
- Study completion5 Jul 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 Chronic Abnormal Immune Activation in HIV/AIDSStudies of the same condition, open and under way.
- More trials run by Shanghai Pharmaceuticals Holding Co., LtdThe sponsor's other registered studies.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 151 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shanghai Pharmaceuticals Holding Co., Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Taisheng Li, PhD, Principal investigator, Peking Union Medical College Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04084444
- Sponsor's protocol ID
- T8-201
- Status last verified
- Jul 2022
- First submitted
- 5 Sep 2019
- Last updated
- 31 Mar 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Cao W, Liu X, Han Y, Song X, Lu L, Li X, Lin L, Sun L, Liu A, Zhao H, Han N, Wei H, Cheng J, Zhu B, Wang M, Li Y, Ma P, Gao L, Wang X, Yu J, Zhu T, Routy JP, Zuo M, Li T. (5R)-5-hydroxytriptolide for HIV immunological non-responders receiving ART: a randomized, double-blinded, placebo-controlled phase II study. Lancet Reg Health West Pac. 2023 Mar 15;34:100724. doi: 10.1016/j.lanwpc.2023.100724. eCollection 2023 May.
PubMed 37283977
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of T8 on Treating Chronic Abnormal Immune Activation in HIV/AIDS Patients: A Multicenter, Randomized, Double-blind, Dose-finding, Placebo-controlled Study
- ClinicalTrials.gov ID
- NCT04084444
- Acronym / sponsor ID
- T8-201
- Keywords
- Chronic abnormal immune activation, AIDS, T8, Efficacy, Safety
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 151 participants (actual)
- Lead sponsor
- Shanghai Pharmaceuticals Holding Co., LtdIndustry (pharma, biotech, devices)
- Study start
- 25 Dec 2019 (actual)
- Primary completion
- 5 Jul 2022 (actual)
- Study completion
- 5 Jul 2022 (actual)
- First posted
- 10 Sep 2019 (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.
This is a multicenter, randomized, double-blind, dose-finding, placebo-controlled study in patients with chronic HIV infection and inadequate immune restoration treated with long-term highly active antiretroviral therapy (HAART). A total of 150 eligible subjects will be selected and randomized at a ratio of 1:1:1 into T8 0.5 mg QD, 1 mg QD, and placebo group, with background HAART unchanged, for 48 consecutive weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| T8 tablet 0.5mg | Experimental | Drug: T8 tablet 0.5mgOral T8 tablet with HARRT, 0.5mg, once daily for 48 week |
| T8 tablet 1mg | Experimental | Drug: T8 tablet 1mgOral T8 tablet with HARRT, 1mg, once daily for 48 week |
| Placebo | Placebo comparator | Drug: PlaceboOral Placebo with HARRT, once daily for 48 week |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Chinese subjects aged 18-65, male or female；
- Subjects with Body mass index (BMI) ≥18 (kg/m2); Male weight ≥50kg, female weight ≥45kg；
- Subjects must meet the criteria;
- No birth planning；
- Understand and sign informed consent form voluntarily.
Key exclusion criteria (10 listed)
- allergic constitution；
- Pregnant or lactating women；
- Subjects who have been diagnosed with malignant tumors；
- Subjects whose laboratory tests meet the conditions；
- Subjects who have been diagnosed with severe gastrointestinal diseases；
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 |
|---|---|---|
| T8 tablet 0.5mgAlso: Leiteng ShuImmune regulation, inhibition of acute nonspecific inflammation and chronic inflammation. | Drug | T8 tablet 0.5mg |
| T8 tablet 1mgAlso: Leiteng ShuImmune regulation, inhibition of acute nonspecific inflammation and chronic inflammation. | Drug | T8 tablet 1mg |
| PlaceboBlank control. | Drug | Placebo |
Primary outcome
CD4+ T lymphocyte count
Time frame: 48 week
The changes of CD4+ T lymphocyte count from baseline
The proportion of subjects whose CD4+ T lymphocyte count increased by≥50 /μL from baseline
Time frame: 48 week
The proportion of subjects whose CD4+ T lymphocyte count increased by≥50 /μL from baseline
The changes of inflammatory factors
Time frame: 48 week
The quantitative changes of inflammatory factors（IP-10、hsCRP、IL-6）from baseline
4 secondary outcomes
CD4+/CD8+T lymphocyte ratio
Time frame: 24 week and 48 week
The proportion of subjects whose CD4+ T lymphocyte count is increased by ≥20% from baseline
Time frame: 24 week and 48 week
The proportion of subjects whose CD4+ T lymphocyte count ≥ 200 /μL
Time frame: 24 week and 48 week
Incidence of AE and SAE
Time frame: 24 week and 48 week
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 31 Mar 2023.
- Derived from this study: PubMed 37283977Cao W, Liu X, Han Y, Song X, Lu L, Li X, Lin L, Sun L, Liu A, Zhao H, Han N, Wei H, Cheng J, Zhu B, Wang M, Li Y, Ma P, Gao L, Wang X, Yu J, Zhu T, Routy JP, Zuo M, Li T. (5R)-5-hydroxytriptolide for HIV immunological non-responders receiving ART: a randomized, double-blinded, placebo-controlled phase II study. Lancet Reg Health West Pac. 2023 Mar 15;34:100724. doi: 10.1016/j.lanwpc.2023.100724. eCollection 2023 May.
- Individual participant dataSharing planned: Undecided
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.
Taisheng Li, PhD principal investigator
Peking Union Medical College Hospital
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing T8 tablet 0.5mg and T8 tablet 1mg in people with Chronic Abnormal Immune Activation in HIV/AIDS, run by Shanghai Pharmaceuticals Holding Co., Ltd at 9 sites 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 5 inclusion and 10 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 31 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites 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. Some participants in this study may receive a placebo. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
CD4+ T lymphocyte count (time frame: 48 week). The study lists 3 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 NCT04084444, 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 31 Mar 2023.