At a glance
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Placebo-Controlled, Dose-Blinded, Dose Escalation Study to Evaluate Safety, Tolerability, Pharmacokinetics and Antiviral Activity of Polyphenon E (EGCG) 14 Day Monotherapy in Antiretroviral Naïve and Experienced, HIV-1-Infected Subjects
In Brief
A Phase 1 clinical trial evaluating Polyphenon E and Placebo for HIV Infection. Completed, enrolled 23 participants across 2 sites.
Detailed 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.
Study Details
Timeline
Interventions
There will be 3 dose levels and for each dose level, there will be 6 subjects who will receive the study drug and 2 subjects who will be randomized to take placebo. Dosing will be escalated sequentially contingent on the safety profile of previous doses. Safety data from all participants receiving Polyphenon® E in the preceding dose level will be evaluated and considered acceptable prior to escalation to the next higher dose. PK analyses will be also performed as each dose level is completed. It is necessary to confirm EGCG pharmacokinetics in the event that the primary outcome measure of virologic response is not observed for each arm. For each PK visit on Study Days 1 and 14, a total of 10 blood samples will be obtained per subject.