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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.
Details
| Lead sponsor | Shanghai Public Health Clinical Center |
|---|---|
| Phase | Phase 1 |
| Status | UNKNOWN |
| Enrolment | 12 |
| Start date | 2020-08 |
| Completion | 2022-12 |
Conditions
- HIV-1-infection
Interventions
- Euphorbia kansui Pill
Primary outcomes
- Change in plasma HIV-1 RNA concentration — Measured on day 0; 1, 3, 5, 7 (12 hours post administration); 14, 21.
- Change in cell-associated HIV-1 RNA — 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 — Measured through 21 days after the first administration of kansui Pill
Countries
China