Project: Research project

Project Details


DESCRIPTION (adapted from application's abstract): The Miami ACTU has been a
member of the AACTG since its inception and has contributed to a number of
AACTG studies that led to the approval of seven antiretroviral drugs and
numerous HIV treatment strategies including lower and alternative dosing
schedules for all three classes of antiretroviral agents, early treatment
intervention, combination therapies with dual NRTIs and triple-drug therapy.
The Miami ACTU has also actively participated in the Virology Laboratory
Subcommittee working groups with an active role in the standardization of a
PBMC culture assay for determining drug susceptibility, the assessment of
interlaboratory concordance of DNA sequencing analysis of HIV RT, and the
development of a consensus sequencing protocol to detect drug resistant
mutations. This unit has also been involved with the Surrogate Markers
Subcommittee with an active role in the assessment of plasma cytokines and
soluble markers, cytotoxic T-lymphocyte activity, lymphocyte proliferation and
advanced flow cytometry, and defining and validating immunologic markers as
surrogate markers independent of CD4 and HIV RNA. Finally, this unit has
contributed to the Pharmacology Committee with the evaluation of targeted-
concentration control studies and the correlation of drug exposure with
treatment response and failure parameters.

The Miami ACTU will actively participate in HIV Disease RAC efforts and
provide expertise to address study treatment strategies for initial therapy,
treatment options for virologic failure and utilization of phenotypic and
genotypic assessments to direct subsequent therapy and treatment
intensification. The Miami ACTU will also bring expertise in the areas of
hepatitis B and C pathogenesis and treatment, metabolic complications of HIV-1
protease inhibitor pathogenesis and treatment, HIV dementia pathogenesis and
treatment and peripheral neuropathy pain assessment, Kaposi sarcoma (KS)
pathogenesis, intensive immunologic monitoring and definition, and validation
of immunologic determinants of treatment response.

The Miami ACTU plans to enroll 100 subjects per year across AACTG studies and
70 patients into AACTG substudies, including but limited to Compartmental,
Virology, Viral Dynamics, Pharmaceuticals, Metabolic, Neurologic, Women's
Health and Adherence and Outcomes substudies. With a support system in place
for the long-term follow-up of patients, the Miami ACTU anticipates to enroll
approximately 80 patients into the ALLRT study (ACTG 5001) over a 2-year
Effective start/end date1/1/9012/31/06


  • National Institute of Allergy and Infectious Diseases
  • National Institute of Allergy and Infectious Diseases
  • National Institute of Allergy and Infectious Diseases: $1,543,843.00


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