A study of a Chinese medicine protocol, to be carried out in the US, was created by two member's of FIAR's team, Mark Kuebel and Fred Blair. Both are Chinese medicine practitioners. The hope is that the herbal formula they developed will be a novel means of extending a structured treatment interruptions. Rather than simply stop medications and await the inevitable decline in CD4 count and rise in viral load, might it be possible to reduce viral activity to a low level with a treatment that detoxifies the body and prevents major AIDS symptoms from developing during the interruption? Using their formula of Chinese herbs, a pilot study is being conducted with volunteers to evaluate its anti-HIV effects.

Objective: Develop an herbal antiviral intervention using principles of Traditional Chinese herbology with input from the western study of Chinese herbs.

Primary Aim: To test the effecacy, in a preliminary pilot study, of an herbal formula on HIV+ volunteers who are beginning a structured treatment interruption (STI) from antiretroviral therapy (ARVT) to evaluate its ability to affect viral load. This will be open label, unblinded and randomized and is intended to serve as a proof of concept in a best case series format.

Lead Personnel: Mark Kuebel, L.Ac., Alfred Blair, L.Ac.

Theoretical Brief: Attempts to use Chinese herbology in achieving a direct anti-HIV affect have been abandoned partly because of the advent of ARVT and partly due to the lack of efficacy of formulas created in the past, such as Enhance and Clear Heat in controlling HIV progression. Because both the investigators are HIV+, their experience with HIV/AIDS medications and alternative and herbal interventions have inspired a new investigation of Chinese herbs to evaluate their potential antiviral effect.

Scrutinizing the lab and quality of life results created in this study with patients starting STI's give immediate feedback with savvy HIV patients already in the health care system. Limitations of the study include the potential for selection bias and the open-label, non-randomized nature of this initial pilot study. However, we anticipate that if significant antiviral activity is noted, it will lead to the development of a larger study.

Participants will be monitored closely during their STI and, through standard clinical care of obtaining periodic bloodwork, can provide the data necessary to determine if the formula works. This model is hoped to result in the retardation of CD4 crashes and viral load spikes in such patients to give them a chance to extend their STI. The study will be undertaken based on the perceived need of the participant to voluntarily begin an STI. This may include relief from toxicities, a high CD4 count that participants feel an STI is warranted or other personal reasons, based on individual choice. Participants will continue to see their physicians for medical advice and other clinical care, including bloodwork.

Materials and Methods: Patients will be selected with specific CD4+/viral load parameters (above 100 T cells), a willingness to comply with herbal therapy, and an impending STI. A Chinese medical diagnosis will aid in determining eligibility. Herb formulas have been assembled using a combination of traditional principles and western scientific research into properties of herbs. Herb formula will be provided to the patients, and endpoint will be exactly the same criterion for reinitiating ARVT, with data collected (CBC, CD4 count, viral load) at markers before, during and at the conclusion of the STI.

Drawing Conclusions: Response to the formula will be determined by analysis of changes in viral load and quality of life evaluation (a modified version of a standardized instrument, with modifications reflecting a Chinese medicine perspective). If no response is achieved, the intervention will either be changed for a future study or abandoned. If a positive response is observed, more careful testing may be undertaken in a larger cohort of STI patients and groups of non-ARVT HIV+ patients with less immediate and less dire circumstances, such as recent HIV seroconverters with near-normal bloodwork.

Progress so far: Gross study design has been mapped out, and formula has been created. Testing of the formula has begun on a pilot study basis. Initial feedback has already generated a modification to the formula. Additional funding is being sought and donations may be made to FIAR earmarked for this specific study. Funds will be utilized to underwrite data collection and analysis, as well as the cost of the intervention so that it may be provided without cost to low-income participants. The investigators are actively looking for volunteer study subjects, and appreciate your contacting them at either of the email addresses below.