| CLINICAL
TRIAL UPDATE
The National Institutes
of Health (NIH) in Bethesda, MD is now screening for HIV-positive nonprogressors
to understand how the immune system controls HIV replication. HIV-positive
people who maintain very low plasma viral loads without antiretroviral
therapy are being recruited for the NIH study. In long-term nonprogressors
(LTNPs), the immune system contains HIV for prolonged periods of time without
antiretroviral medication. Immune system-related genes, certain HLA class
I alleles, have been identified to be important in these patients.
The NIH studies require
larger quantities of plasma and mononuclear cells than can be readily obtained
by simple phlebotomy. These components can be easily and safely obtained
using leukapheresis procedures in the Clinical Center Apheresis Unit. Some
of the blood collected through apheresis will be used for HLA haplotyping
and may be stored for future studies of HIV disease and immune function.
The clinical research
project document entitled, "Leukapheresis procedures to obtain plasma or
lymphocytes for research studies of HIV-infected patients, including long-term
nonprogressors," is provided to CPCRA investigators and includes further
details of the screening project being conducted under Mark Connors, MD,
at the National Institute of Allergy and Infectious Disease (NIAID).
Eligibility criteria described
below are broader than those described in the research project document
because patients may be determined to be potentially eligible for additional
research projects. Updated information can be found on the NIAID
web site.
Eligibility criteria for
this study includes:
-
HIV-1-positive Adult (at
least 18 years of age)
-
Stable plasma viral loads
=5000 copies/mL for a minimum of 3 years
-
CD4 counts =350 cells/ L
for a minimum of 3 years
-
Return visits to NIH at approximately
6-month intervals
-
Willingness to provide informed
consent for HLA testing and the storage of blood or tissue samples
Exclusions:
-
Antiretroviral therapy (within
the previous 3 years)
Financial compensation
is provided for study participants and may be discussed with the Study
Coordinator. Patients potentially interested in being screened for study
eligibility should contact the Study Coordinator, Mary McLaughlin, RN,
BSN, at 800/772-5464, extension 58001.
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