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HIV-1-infectionPhase 1NCT04503928

Euphorbia Kansui and HIV/AIDS Functional Cure

A Phase 1 study testing Euphorbia kansui Pill in people with HIV-1-infection, run by Shanghai Public Health Clinical Center at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

The purpose of this study is to determine the safety and bioactivity of Euphorbia kansui, which has been used in traditional Chinese medicine for the treatment of edema, ascites, and asthma. 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?
Euphorbia kansui Pill
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
12 participants
Where
1 siteChina
Study dates
Aug 2020to Dec 2022
Phase
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

  • HIV-1 infection
  • Age ≥18 years; Willingness to give written informed consent.
  • Karnofsky performance status >70.
  • Able, willing to adhere to therapy and adherent to ART.
  • Able, willing to comply with time requirements for study visits and evaluations.
  • On potent combination ART for ≥ 18 months prior to study entry.
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  • Able to swallow pills without difficulty.
  • HIV-1 RNA values <50 copies/mL for at least 18 months.
  • CD4 cell count ≥ 500 cells/µl at screening.
  • CD4 T cells isolated in vitro and stimulated with kansui, and the kansui activation test is positive.
  • All volunteers must agree not to participate in a conception process.
  • Must have adequate organ function as indicated by the following lab values:
  • Hematological: Absolute Neutrophil Count (ANC) ≥ 1,500/mcL Platelets ≥ 125,000/mcL Hgb ≥ 12 g/dL Coagulation: Prothrombin Time or International Normalized Ratio (INR) ≤ 1.5x upper limit of normal (ULN) Chemistry: K+ levels Within normal limits Mg++ levels > Lower limits of normal (LLN) but <1.5 x ULN Glucose Screening serum glucose(fasting/non-fasting) below 120 mg/dl.
  • Renal: Serum creatinine/calculated creatinine clearance ≤ 1.3 X ULN OR ≥ 60 mL/min for participants with creatinine levels > 1.3 X ULN Hepatic: Serum total bilirubin Total bilirubin < 1.5 times ULN. If total bilirubin is elevated, direct bilirubin will be measured and the participant will be eligible if the direct bilirubin is < 2 X ULN.
  • Aspartate amino transferase (AST) (SGOT) and Alanine amino transferase (ALT) (SGPT)≤ 2.0 X ULN Lipase <1.6 X ULN Alkaline Phosphatase ≤ 2.5 X ULN.

Who cannot join

  • Acute HIV-1 infection
  • Received blood transfusions or hematopoetic growth factors within 3 months
  • Receipt of compounds with other latency activators within 1 month.
  • Any significant acute medical illness in the past 8 weeks
  • Hepatitis B or C infection as indicated by the presence of Hepatitis B surface antigen (HBsAg) or hepatitis C virus RNA (HCV-RNA) in blood
  • Patient has the following laboratory values within 3 weeks before starting the investigational drug Hepatic transaminases (AST or ALT) ≥3 x upper limit of normal (ULN) Serum total bilirubin ≥1.5 ULN Serum creatinine levels ≥1.5 x ULN, or calculated creatinine clearance ≤60 ml/min Platelet count ≤100 x109/L Absolute neutrophil count ≤1.5x109/L Serum potassium, magnesium, phosphorus outside normal limits Total calcium (corrected for serum albumin) or ionized calcium ≤lower normal limits
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  • A personal history of clinically significant cardiac disease, symptomatic or asymptomatic arrhythmias, syncopal episodes, or additional risk factors for Torsades de pointes (e.g. heart failure)
  • History of malignancy or transplantation, including skin cancers or Kaposi sarcoma
  • History of diabetes mellitus
  • Known hypersensitivity to Kansui
  • Pregnancy or breast feeding, or expecting to father children within the projected duration of the study
  • Known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial

Trial locations and contacts

1 site in 1 country.

Huanzhang Zhu, M.D. contact

31246728

hzzhu@fudan.edu.cn

Jingna Xun, MD contact

37990333 ext. 5321

xunjingna@shphc.org.cn

China1 site

  • Shanghai,China, Fudan University

    Shanghai

    Huanzhang Zhu, M.D.

    Huanzhang Zhu, M.D.

Other trials in China

About this study

Official title: Euphorbia Kansui in Combination With Antiretroviral Therapy for Eradication of the Latent HIV-1 Reservoir

The purpose of this study is to determine the safety and bioactivity of Euphorbia kansui, which has been used in traditional Chinese medicine for the treatment of edema, ascites, and asthma. The investigators previously reported that effective fractions from the dichloromethane extracts of the roots of Euphorbia kansui can reactivate latent HIV-1 replication in different latent cells (The 24th China science technology Forum-High level Forum on HIV cure, December 16-17, 2012, Beijing). Importantly, in resting CD4+ T cells of HIV-1-infected patients on suppressive antiretroviral therapy (ART), it could effectively induce ex vivo latent HIV-1 expression. Sera from rats receiving orally administered effective fractions were able to reactivate latent HIV-1. The investigators also found a substantially potent ingenol derivative EK-16A, EK-1A, EK-5A, EK-15A from Euphorbia kansui and proved that it was potent in reversing HIV-1 latency. The investigators' hypothesis is that Euphorbia kansui Pill will be safe and well-tolerated and at the doses administered, increase HIV transcription in latently-infected cells among HIV-infected patients on suppressive antiretroviral therapy.

Read the detailed description

Every participant will receive oral Euphorbia kansui Pill every day. The dose of Euphorbia kansui will be 1g each time for 7 consecutive days. All participants will keep their antiretroviral therapy during this study.

Each step of this study will last for 21 days, involving 7 study visits (Screening,Day 0, 1, 3, 5, 7, 14, 21) for every participant. At the screening visit, participants will give a medical history and will undergo a physical exam; blood samples will be collected. Participants will undergo pharmacodynamic sampling which will require that blood be collected 12 hours after kansui Pill administration on Day 1, 3, 5,7. If participants agree, their blood samples may be stored for future research.

Conditions
HIV-1-infection
Being tested
Euphorbia kansui Pill

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Euphorbia kansui PillDrug

    Also called kansui

    1 g (10 pills) of Euphorbia kansui Pill taken by mouth, once a day for 7 consecutive days.

Study groups in NCT04503928
Study groupRoleWhat they receive
Experimental: Kansui 1g per day x 7 daysExperimentalStudy participants will be given 1 g of Euphorbia kansui Pill for a total of 7 consecutive daily doses.
Receives: Drug: Euphorbia kansui Pill

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in plasma HIV-1 RNA concentration

    Measured: Measured on day 0; 1, 3, 5, 7 (12 hours post administration); 14, 21.

  2. Change in cell-associated HIV-1 RNA

    Measured: on day 0; 1, 3, 5, 7 (12 hours post administration); 14, 21

  3. Number of participants with treatment-related adverse events as assessed by CTCAE v4.0

    Measured: Measured through 21 days after the first administration of kansui Pill

Secondary outcomes (1)

  1. Change in cell-associated total HIV-1 DNA

    Measured: Measured on day 0, 14, 21

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Aug 2020
  2. Study startAug 2020 (estimated)
  3. Primary completionAug 2022 (estimated)
  4. Study completionDec 2022 (estimated)

Resources

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 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
12 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04503928
Sponsor's protocol ID
Euphorbia kansui V1
Status last verified
Aug 2020
First submitted
5 Aug 2020
Last updated
10 Aug 2020
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Wang P, Lu P, Qu X, Shen Y, Zeng H, Zhu X, Zhu Y, Li X, Wu H, Xu J, Lu H, Ma Z, Zhu H. Reactivation of HIV-1 from Latency by an Ingenol Derivative from Euphorbia Kansui. Sci Rep. 2017 Aug 25;7(1):9451. doi: 10.1038/s41598-017-07157-0.

    PubMed 28842560

  • Yang H, Li X, Yang X, Lu P, Wang Y, Jiang Z, Pan H, Zhao L, Zhu Y, Khan IU, Shen Y, Lu H, Zhang T, Jiang G, Ma Z, Wu H, Zhu H. Dual effects of the novel ingenol derivatives on the acute and latent HIV-1 infections. Antiviral Res. 2019 Sep;169:104555. doi: 10.1016/j.antiviral.2019.104555. Epub 2019 Jul 9.

    PubMed 31295520

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Euphorbia kansui Pill 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 15 inclusion and 12 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 10 Aug 2020. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

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 Huanzhang Zhu, M.D. (31246728, hzzhu@fudan.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in plasma HIV-1 RNA concentration (time frame: Measured on day 0; 1, 3, 5, 7 (12 hours post administration); 14, 21.). 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 NCT04503928, which also lists 2 linked publications.

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 10 Aug 2020.

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