drugset / Trial / NCT01433289
Study to Evaluate Safety and Toxicity of Polyphenon E (EGCG) in HIV-1-Infected Individuals
Phase 1
Completed
23 enrolled
Baylor College of Medicine
National Center for Complementary and Integrative Health (NCCIH) · collab
RandomizedParallel-groupDouble-blindTreatment
Summary
The purpose of this study is to determine the safety, toxicity, dosing, and antiviral effects of epigallocatechin gallate (EGCG) in capsule form (Polyphenon® E), administered orally twice daily at three different doses in HIV-1-infected clinically stable, treatment-naïve and treatment-experienced adults not on concomitant antiretroviral (ARV) therapy.
Timeline
- Start
- 2010-12
- Primary completion
- 2014-08
- Completion
- 2015-07
Outcome
Missed primary endpoint
registry analysis (superiority test); Polyphenon E 1600 mg/Day vs Polyphenon E 2400 mg/Day vs Polyphenon E 3200 mg/Day vs Placebo Placebo; p = 0.74 NCT01433289 ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Epigallocatechin gallate | Small molecule | 1600 mg | Oral |
| Subject | Epigallocatechin gallate | Small molecule | 2400 mg | Oral |
| Subject | Epigallocatechin gallate | Small molecule | 3200 mg | Oral |