397that compared a genotypic test with a phenotypic test for identifying patients who
may benefi t from Celsentri/Selzentry. Siemens Healthcare Diagnostics (SHD) pro-
vided genotypic testing in the trial, while Monogram Biosciences (subsidiary of
LabCorp) provided phenotyping testing. In 2011, SHD started a partnership to make
its Trugene molecular HIV-1 test compatible with Illumina’s MiSeq benchtop
sequencing system and to set new standards for the use of NGS for the identifi cation
of HIV-1 and potential treatments paths. The study was terminated in 2013 follow-
ing a preliminary review of the Week 48 primary effi cacy data by the study’s exter-
nal independent Data Monitoring Committee (DMC). The DMC assessed the data
as demonstrating signifi cant differences between the treatment arms in virologic
responses and failures. The DMC recommended and the Sponsor concurred that the
study be terminated because of the inferior effi cacy of the Maraviroc arm as com-
pared to the comparator arm (Emtricitabine/Tenofovir).
CD4 Counts as a Guide to Drug Therapy for AIDS
When patients are infected with HIV/AIDS, the number of circulating CD4 T-cells
drops signifi cantly. CD4 counts assist in the decisions on when to initiate and when
to stop the treatment, which makes this test so important. While such testing is rou-
tine in Western countries and used repeatedly over the course of treatment to see if
interventions are effective it is unavailable to many people in the developing world,
especially in rural areas. A cheap test for CD4 plus T lymphocytes in the blood is in
development using biosensor nanovesicles to enhance the signal.
Role of Biomarkers in Management of HIV/AIDS
Direct detection of HIV-1 is diffi cult because only a small number of cells harbor
the virus, a small number of proviral copies exist in each infected cell, and the viral
genome has a tendency toward transcriptional dormancy. There is a need for bio-
markers that can be used to monitor the course of HIV/AIDS and to assess the effect
of antiretroviral therapy.
APOBEC3G (apolipoprotein B mRNA-editing enzyme, catalytic polypeptide-
like 3G; also known as CEM15, or hA3G) is a novel cellular factor of innate immu-
nity that inhibits HIV replication in vitro by causing G to A hypermutations, and
consequently reduced relative infectivity of each virus produced by infected cells.
Quantifi cation of CEM15 mRNA levels in patient samples has been used as a prog-
nostic indicator of innate HIV/AIDS disease resistance and for predicting whether
a viral infected patient will be categorized as a long term nonprogressor, which has
a much slower disease progression rate (Jin et al. 2007 ). This also provides a method
of predicting the level of CD4 cells in a patient, as well as a method of optimizing
antiviral therapy in a viral infected patient and has signifi cant implications on new
development of diagnostic tools and therapeutic targets to treat viral infections.
Personalized Management of Viral Infections