Euphorbia Kansui and HIV/AIDS Functional Cure
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT04503928|
Recruitment Status : Not yet recruiting
First Posted : August 7, 2020
Last Update Posted : August 10, 2020
|Condition or disease||Intervention/treatment||Phase|
|HIV-1-infection||Drug: Euphorbia kansui Pill||Phase 1|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||12 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||All participants eligible for study received the same open label drug|
|Masking:||None (Open Label)|
|Masking Description:||Open label|
|Official Title:||Euphorbia Kansui in Combination With Antiretroviral Therapy for Eradication of the Latent HIV-1 Reservoir|
|Estimated Study Start Date :||August 2020|
|Estimated Primary Completion Date :||August 2022|
|Estimated Study Completion Date :||December 2022|
Experimental: Experimental: Kansui 1g per day x 7 days
Study participants will be given 1 g of Euphorbia kansui Pill for a total of 7 consecutive daily doses.
Drug: Euphorbia kansui Pill
1 g (10 pills) of Euphorbia kansui Pill taken by mouth, once a day for 7 consecutive days.
Other Name: kansui
- Change in plasma HIV-1 RNA concentration [ Time Frame: Measured on day 0; 1, 3, 5, 7 (12 hours post administration); 14, 21. ]
- Change in cell-associated HIV-1 RNA [ Time Frame: on day 0; 1, 3, 5, 7 (12 hours post administration); 14, 21 ]
- Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 [ Time Frame: Measured through 21 days after the first administration of kansui Pill ]
- Change in cell-associated total HIV-1 DNA [ Time Frame: Measured on day 0, 14, 21 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04503928
|Contact: Huanzhang Zhu, M.D.||firstname.lastname@example.org|
|Contact: Jingna Xun, MD||37990333 ext email@example.com|
|Shanghai,China, Fudan University|
|Contact: Huanzhang Zhu, M.D.|
|Principal Investigator: Huanzhang Zhu, M.D.|
|Principal Investigator: Hongzhou Lu, M.D.|
|Principal Investigator:||Hongzhou Lu, M.D.||Shanghai Public Health Clinical Center|
|Principal Investigator:||Huanzhang Zhu, M.D.||Fudan University|