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CD4 QTest: a CD4 enumeration screening test. The CD4QTest is the only method for obtaining CD4 counts that is cell-free requiring only a saliva sample. Because the CD4 QTest requires no blood or expensive reagents, the cost and implementation of the test is ideal for the resource-limited regions where HIV is endemic. The CD4 QTest has the potential to have a major impact on the number of HIV infected individuals on ART, the frequency of HIV transmission, and the cost and health outcomes of patients, all of which markedly impact global economy.

Therapy for elevating CD4 counts. With collaborators at CSL Behring, Bristow showed in a successful clinical trial that CD4 T cells dramatically increased in HIV and non-HIV patients within 2 weeks of initiating α1PI augmentation therapy unlike anything that has ever been observed previously. CD4 counts in one HIV patient increased to normal levels for the first time in 20 years. The increase in CD4 counts in one patient from the stud y is depicted. Blue circles represent CD4 counts prior to initiating ART, purple triangles represent CD4 counts on ART, and green circles represent CD4 counts following initiation of α1PI therapy. A second, confirmatory clinical trial with additional medical measurements is currently underway in collaboration with Grifols Biotherapeutics.

Therapy for lowering LDL. A remarkable windfall in the discovery that α1PI regulates CD4 counts is that in doing so, α1PI incorporates the same mechanisms that regulate HDL and LDL levels. The same therapy that elevates CD4 counts in HIV disease also raised HDL (good cholesterol) and lowered LDL levels (bad cholesterol).

Small molecule and peptide therapy to elevate CD4 counts. The primary cause of low CD4 counts in cancer is cancer therapy whereas the primary cause of low CD4 counts in HIV/AIDS is the inactivation and deficiency of α1PI which is necessary for regulating CD4 counts. In both cases, CD4 counts can be elevated using small molecules as a substitute for α1PI. In HIV/AIDS, an additional approach is possible.

Small molecule and peptide therapy to lower LDL levels. Dietary fats are transported from the intestinal lumen to blood via migrating CD4 cells, and α1PI is required for CD4 cell migration. There are several clinical situations that produce α1PI deficiency including genetics, liver failure, diabetes, and infection/inflammation including HIV/AIDS. Incidental to theses clinical situations, lower CD4 counts and cardiovascular disease are frequent complications. Bristow has discovered that α1PI regulates HDL and LDL levels as a consequence of its participation in CD4 cell migration. Because of this phenomenon, it is possible to increase or decrease HDL and LDL levels by using small molecules and peptides targeting the mechanism by which α1PI induces cells to migrate.

HIV Vaccine development : HIV and HIV vaccines impede the mechanism that regulates CD4 T cells and LDL levels. Modification of current vaccine designs can provide protection against AIDS as opposed to the current approach to protect against HIV infection. This novel vaccine concept is complementary, not competitive with current vaccine designs.

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