In lipid coated virus (LCV) and lipid coated bacterium (LCB) research, a proof-of-concept clinical trial is an organized study conducted on people with specific LCVs and/or LCBs to answer specific questions about new treatments and/or new ways of using known treatments.  Besides studying monoglycerides, proof-of-concept clinical trials can also look at monoglycerides as adjunct to existing drugs already used in LCV and LCB treatment, as well as how changes in dietary intake of monoglycerides can help patients prevent LCVs and LCBs from occurring.

Lauric.org proposes to find a sponsor for a six month, three-site, proof-of-concept trial in the U.S. that lauric.org is developing based on newly designed lauric/capric acid protocols for HIV/AIDS (A-0114) and Mother-Infant HIV Transmission (A-0118).  Below is an outline for the proposed HIV/AIDS (A-0114) trial that provides a description, length of trial, objective, inclusion criteria, exclusion criteria, statistical design, and study design.

If your hospital, university research facility, or HIV/AIDS treatment clinic is interested in participating in this proposed trial and would like to be considered as a possible site, please go to the Proof-of-Concept Trial Preliminary Budget Cost form and provide the necessary information about your institution, patient population, and funding requirements, if any.  After your form submission has been received and reviewed, lauric.org may invite your institution to submit a formal proposal for inclusion in our proposal for funding.

• Proof-of-concept trial with pharmacologically-naive subjects, and/or
• Salvage trial with failed treatment subjects.

• 6 months

Objective:

• This study will test the use of lauric fats in the diet as physiologically functional foods for the following objectives:

1. To lower viral load in HIV-infected individuals;
2. To lower P24 antigen;
3. To raise CD4 and/or CD4/CD8.

• The study will also determine subjective sense of well-being.

Inclusion criteria:

• HIV+ individuals with an elevated viral load that is sufficiently elevated so that a measure of reduction could be determined.
• Individuals with a low CD4 or a low CD4/CD8 value.

Exclusion criteria:

• HIV+ individuals who are on polydrugs including protease inhibitors and whose viral loads have been reduced to a level that is not measurable.

• n=1, individual pretreatment as own control