Status:
UNKNOWN
Euphorbia Kansui and HIV/AIDS Functional Cure
Lead Sponsor:
Shanghai Public Health Clinical Center
Collaborating Sponsors:
Fudan University
Shanghai Xinhao Biological Technology Co., Ltd.
Conditions:
HIV-1-infection
Eligibility:
All Genders
18-65 years
Phase:
PHASE1
Brief 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. The inves...
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 d...
Eligibility Criteria
Inclusion
- 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.
- 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.
Exclusion
- 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
- 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
Key Trial Info
Start Date :
August 1 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2022
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT04503928
Start Date
August 1 2020
End Date
December 1 2022
Last Update
August 10 2020
Active Locations (1)
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1
Shanghai,China, Fudan University
Shanghai, China