Immunologic Response to Kansui in Treated HIV+ Individuals: a Dose Escalation Study

HIV Clinical Trial

Official title: Immunologic Response to Euphorbia Kansui Extract Powder Prepared as Tea in HIV-infected Antiretroviral Therapy (ART)-Suppressed Individuals: a Dose Escalation Study

Status Terminated

Clinical Trial Summary

The purpose of this study is to determine the safety and bioactivity of an herbal supplement called "kansui," which contains several active ingredients such as ingenols that may have a role in helping clear HIV from the body. Kansui has been used in traditional Chinese medicine for centuries to treat various ailments such as for eliminating excess fluid in the abdomen or lungs, loosening phlegm from the chest, and relieving constipation. Based on preliminary in vitro data from our group, kansui extract powder is a potent activator of HIV transpcription in latently infected Jurkat cells. The investigators' hypothesis is that kansui extract powder prepared as tea will be safe and well-tolerated, elicit an in vivo immunologic response, and at the doses administered, increase HIV transcription in latently-infected cells among HIV-infected patients on suppressive antiretroviral therapy.

Clinical Trial Description

Millions HIV-infected individuals are now receiving life-saving antiretroviral therapy (ART). However, mortality remains high, particularly in resource-limited countries. Chronic HIV-infected individuals demonstrate evidence of persistent immune activation despite ART, which is an independent predictor of mortality in this setting. Given the current absence of an effective HIV vaccine, finding a cure for HIV will have a large impact on the long-term health of treated HIV-infected individuals. The key challenge of HIV eradication strategies is the persistence of a small pool of resting memory CD4+ T cells that harbor latent replication-competent HIV, untouched by current ART. One potential strategy to eliminate this reservoir in a "shock and kill" approach in which latency reactivating agents (LRAs) are used to "shock" the virus out of these cells in order for the host immune response, ART, and/or additional immunomodulatory agents to then kill the virus-expressing cells. The goal of the current study is to evaluate the safety and in vivo biological response to an herbal supplement used in traditional Chinese medicine ("kansui)" that has potent in vitro latency reactivating capabilities. Kansui is an inexpensive, readily available herbal supplement prescribed for thousands of years in traditional Chinese medicine and contains active compounds such as ingenols that have been shown to reverse latency in an animal model. A semi-synthetic form of ingenol has been shown to potently reactivate latent simian immunodeficiency virus (SIV) in rhesus macaques and is currently undergoing early drug development. Though kansui has been studied extensively in traditional Chinese medicine, this herbal supplement has never been evaluated for biologic activity in HIV disease using Western scientific research methods. This pilot clinical trial will generate preliminary results regarding the safety and in vivo biologic activity of kansui. Promising results from this study may allow future larger studies which can evaluate the efficacy of this non-pharmacologic agent in the treatment of HIV disease. ;

Related Conditions & MeSH terms

• Acquired Immunodeficiency Syndrome
• HIV
• HIV Infections
• Human Immunodeficiency Virus

• NCT number: NCT02531295
• Study type: Interventional
• Source: University of California, San Francisco
• Status: Terminated
• Phase: Phase 1
• Start date: May 15, 2019
• Completion date: March 19, 2020