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Abstract
Grant Number: 1R21AT004673-01 Project Title: Phase I Study to Evaluate Safety and Toxicity of EGCG in HIV-1-Infected Subjects
PI Information: Name Title NANCE, CHRISTINA L. clnance@texaschildrenshospital.org Abstract: DESCRIPTION (provided by applicant): More than 30 million adults and children worldwide have died from acquired immunodeficiency syndrome (AIDS) and 40 million are living with the human immunodeficiency virus (HIV). A new infection occurs somewhere in the world approximately every six seconds. More than 95% of new infections occur in developing countries where limited resources and cultural factors make containment of the epidemic difficult. The impact of the current level of HIV seroprevalence is enormous in terms of mortality, resource depletion, and human suffering. There is clearly an unmet need for treatment of individuals already infected. However, there is also a desperate need to prevent further infection. Novel therapeutic complementary and alternative medicines (CAM) have been found in natural products. One such CAM candidate is the green tea catechin, epigallocatechin gallate (EGCG). EGCG, a naturally-derived anti-HIV agent, has been shown to bind to the HIV-1-gp120 binding site on the CD4 molecule with sufficient affinity to prevent the HIV-1 virion from attaching to the target cell, CD4, thus inhibiting infection. Phase I clinical trials have established EGCG to be safe and well tolerated in healthy participants. Therefore, the purpose of this study is to determine the safety, toxicity, pharmacokinetics, HIV-1 viral load change, and dosage of EGCG administered orally once (600 or 1000mg) or twice (800mg) daily in HIV-1-infected clinically stable, individuals not currently on antiretroviral (ARV) therapy. This is a single-site, phase I, placebo-controlled, dose-blinded, randomized study of EGCG as monotherapy in participants who are HIV-1-infected with a CD4+ T lymphocyte count of at least 250 cells/mm3 and are ARV- na ve or ARV-experienced. The primary outcome of safety and tolerability will be measured by monitoring adverse events, vital signs, and clinical laboratory data. Plasma pharmacokinetic parameters of EGCG will be determined after a single-dose and at steady state. HIV-1 viral load evaluation will be assessed based on mean change of log10 HIV-1 RNA in participants who have completed treatment. In order to achieve blinding of the study, the total number of capsules that each participant is to take will be the same (five capsules by mouth twice daily). The results from this preliminary research in humans will lay a foundation for justification of larger clinical trials and the development and advancement of EGCG as an inexpensive, readily available, non-toxic, naturally derived anti-HIV agent as CAM in the management of HIV/AIDS. As the global HIV/AIDS epidemic continues largely unchecked without the development of a vaccine on the horizon, there is an urgent need to expand the range of interventions. The data generated from this clinical study of the safety, toxicity, tolerability, and pharmacokinetics of the green tea catechin, EGCG could lead to the successful development of an inexpensive, readily available, non-toxic, naturally-derived anti-HIV agent, EGCG. This could result in a significant reduction in the national and global spread of HIV-1 infection with an enormous impact on public health. PUBLIC HEALTH RELEVANCE: As the global HIV/AIDS epidemic continues largely unchecked without the development of a vaccine on the horizon, there is an urgent need to expand the range of interventions. The data generated from this clinical study of the safety, toxicity, tolerability, and pharmacokinetics of the green tea catechin, EGCG could lead to the successful development of an inexpensive, readily available, non-toxic, naturally-derived anti-HIV agent, EGCG. This could result in a significant reduction in the national and global spread of HIV-1 infection with an enormous impact on public health.
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Institution: BAYLOR COLLEGE OF MEDICINE 1 BAYLOR PLAZA HOUSTON, TX 770303498 Fiscal Year: 2008 Department: PEDIATRICS Project Start: 01-AUG-2008 Project End: 31-JUL-2011 ICD: NATIONAL CENTER FOR COMPLEMENTARY & ALTERNATIVE MEDICINE IRG: ZAT1