Brief Summary
The investigators are collecting data on ViraPhyte™ to determine whether it is able to slow disease progression in HIV+ patients. In order to study ViraPhyte™, the study is collecting blood work on participants who are not currently using antiretrovirals, and who are taking the formula on a daily basis. The study looks at changes in T-cell and HIV viral load counts, changes in other blood work values, and changes in quality of life. We are also looking for any side effects that might occur from the herbs.
The study is straightforward: a volunteer who meets the criteria, as stated below, gives us a confidential copy of his/her most recent blood work, including a T-cell and viral load counts. He/she begins the herb formula, and stays in contact with the investigators, especially during the first 2 months. This allows the investigator to evaluate whether any side effects are occuring, and offers the patient the opportunity to have any questions answered. This is also the period when the dose may be adjusted. Every 3 months, the volunteer should have blood work done, and share those results with the investigators. Data is recorded anonymously, and will help to determine, along with other collected results, how well ViraPhyte™ works against HIV. We encourage, if feasible, at least a 6-month course of herbs, with blood work results shared before and during the use of ViraPhyte™. A participant is not obligated to stay on ViraPhyte™, and can stop the formula at any time. There is no compensation for participating, but investigators are available to consult with participants and answer questions at no cost.
Criteria/Exclusion Criteria
The investigators are enrolling persons with T-cells of 250 and higher. This is because the anti-HIV effects of ViraPhyte™ are still under investigation, and persons with less than 250 T-cells may be at risk for opportunistic infections. The participant can previously have been on antiretroviral drugs, or can be treatment naive, and should:
1.
Not be currently taking antiretroviral drugs
2.
Have no current AIDS-defining opportunistic
infections
3.
Have access to blood work every 3 months
4.
Be willing to sign a consent form so that the
investigators can use the data for the study
Exceptions: If a participant does not have access to blood work due to lack of coverage, we will still want people in need to participate. We welcome anyone who meets criteria #1 and #2 to use our product, and report their results to us, even if the information is anecdotal.
History of this Study
In 2002 the investigators, Fred Blair and Mark Kuebel, started a review of medical literature on Chinese medicine and HIV. The goal of this project was to develop an herbal treatment that could delay the need for HIV drug treatment, as well as provide a beneficial stopgap for patients experiencing antiretroviral treatment interruptions. A model or “treatment principle” was developed based on integrating the observations of Chinese medical practitioners who have treated HIV over the last 25 years. Within this Chinese medical model, the investigators further refined herb choices by utilizing information gathered from Western medical studies specific to HIV disease. Herbs were chosen not only for their potential anti-HIV (anti-viral) properties, but also for their ability to moderate host cellular factors, which are not prone to mutation, such as cytokine dysregulation, immune hyper-activation, inflammation and apoptosis. The investigators then developed a preliminary version of ViraPhyte™. Volunteers tested this formula in 2003–2004 to gauge its safety, as well as to observe if there were any positive effects. Although the number of volunteers was small, the formula was well-tolerated, and exhibited beneficial effects on blood work parameters and quality of life. This encouraged the investigators to further develop the formula, and to refine it as on ongoing HIV research has developed.
In September of 2006, the investigators, with the aid of FIAR (Foundation for Integrative AIDS Research), were awarded a capacity development grant from NCCAM, the National Center for Complementary and Alternative Medicine, a division of the National Institutes of Health. The purpose of the grant has been to develop the ability of the clinicians in a in non-pharmaceutical system of medicine to research their methods of treating HIV disease. This grant has enabled the investigators to study ViraPhyte™ and further research herbs and HIV disease.
The investigators are reaching out to the HIV/AIDS community to generate interest in testing and studying ViraPhyte™, and appreciate your interest. We want to answer any questions from potential participants or from practitioners who are interested in this work. Our goal is to have enough data to apply for a clinical trial grant through the National Institutes of Health or other granting institutions who are interested in sponsoring herbal medicine research.
