AIDS and HIV Related Research
National Institutes
of Health (NIH)
National Institute of Allergy
and Infectious Disease (NIAID) Intramural Program
Volunteer Recruitment
NIH houses the nation’s
most renowned biomedical research institutions. These studies
are conducted by the NIAID and the NIH Clinical Center, located
in Bethesda, Maryland. For additional information on the specific
studies listed here, contact the appropriate coordinator listed
below.
HIV
Studies of Lymphocyte
Kinetics Using Stable Isotopes (Deuterium - 97-I-0191)
Contact: William Sachau,
RN 1-800-772-5464 ext. 5-7940
The purpose of this study
is to learn more about how quickly blood cells, especially
CD4 lymphocytes, replicate and how long they live. Understanding
what happens to CD4 lymphocytes in HIV-infected patients should
provide a better understanding of how certain therapies, such
as antiretroviral treatments and/or IL-2, affect the immune
system. Study requirements include admission to the inpatient
unit for a 5-day glucose infusion and apheresis procedures
during study visits. Participants will be reimbursed for their
time and inconvenience.
Interrupted vs Continuous
Anti-viral Thearpy (HAART) in HIV-infected individuals (M77-02-1-0013)
Contact: Diane Rock-Kress,
RN 1-800-772-5464 ext. 5-8003
This 72 week study will have
2 groups: one group will continue receiving their current
therapy and one group will stop their therapy every other
week (7 days). You may be eligible if you are: (1) 18 years
or older (2) receiving effective anti-HIV medications with
an undetectable viral load for >= 1 month (3) have a CD4
T-cell count of >= 175 cells/mm3 and (4) NOT receiving
nevirapine or abacavir containing regimen. Study related medications
and clinical care will be provided during the study. Many
studies of HIV and the immune response to HIV will also be
done.
Study of Lymphocyte
Kinetics using Bromodeoxyuridine (BrDu)
Contact: Betsey Herpin,
RN, MSN 1-800-772-5464 ext. 5-7630
This study is designed to
measure the rate of lymphocyte replication and destruction
in persons with HIV infection who have virologic but not immunologic
response to HAART. Patients must have a viral load less than
500 copies/ml for greater than one year and less than 50 copies/ml
at the NIH, and, (group 1), a CD4 count of less than 300 cells/mm3,
or, for comparison, (group 2), a CD4 count of greater than
350 cells/mm3, with a pre-HAART CD4 count of less than 300
cells/mm3. Participants will receive one to two 30-minute
infusions of BrDu and will be followed with frequent serial
laboratory studies. Additional laboratory studies and a CT
scan of the thymus will also be performed. HIV-infected patients
with viral loads greater than 20,000 copies/ml will also be
evaluated for study participation. Compensation for study
participation will be provided.
A Phase III Multicenter
Randomized Study of the Biological and Clinical Efficacy of
Subcutaneous Recombinant, Human Interleukin-2 in HIV-infected
Patients with Low CD4+ Counts Under Active Antiretroviral
Therapy (SILCAAT-01-I-0126)
Contact: Linda Coe, RN,
MSN 1-800-772-5464 ext. 2-1420
This is an open-label, phase
III, multicenter international trial to evaluate and compare
the effectiveness of IL-2 combined with antiretroviral therapy,
versus antiretroviral therapy alone, on disease progression
of people with HIV infection. Patients with CD4 cell counts
between 50-299 cells/mm3 will be randomized to receive either
subcutaneous IL-2 plus antiretroviral therapy, or antiretroviral
therapy alone.
Lymphapheresis
(81-I-0164)
Contact: Linda Ehler,
RN, MN 1-800-772-5464 ext. 5-7687
This study is seeking HIV-infected
volunteers with CD4 counts > 200. Volunteers will participate
in a 45-minute apheresis procedure involving removal of some
white blood cells from the circulating blood. Study is only
recruiting patients residing in the Washington, DC, Maryland,
Virginia metropolitan area. Financial compensation is provided
for participating in this study.
Pregnancy Pharmacokinetics
(00-I-0213)
Contact: Barbara Hahn,
RN 1-800-772-5464 ext. 5-8007
This study is seeking pregnant
HIV-infected women on HAART therapy. The purpose of this study
is to see if the amount of antiretroviral drugs in the blood
of pregnant women changes during the different stages of pregnancy.
Blood samples will be collected intermittently for 12 hours
at two to four different time points, every 6-12 weeks. Financial
compensation is provided.
ESPRIT Interleukin-2
(00-I-0071)
Contact: Doreen Chaitt,
RN, MPH 1-800-772-5464 ext. 5-8008
This is an open label, phase
III, international trial to determine if IL-2, combined with
antiretroviral therapy, prolongs the health of people with
HIV infection. Patients with CD4 cell counts > 300 cells/mm3
will be randomized to receive either subcutaneous IL-2 plus
antiretroviral therapy or antiretroviral therapy alone.
Analysis of HIV
Genetic Variation (00-CC-0110)
Contact: Diane M. Rock-Kress,
RN 1-800-772-5464 ext. 5-8003
This study will attempt to
derive a comprehensive description of HIV population genetics.
This study seeks men and women who are HIV positive with CD4+
cell counts in all ranges and viral load of at least 1000
copies/ml at time of screening. Participants must be antiretroviral
naïve. All participants will have viral load and CD4 testing
of blood as well as genotyping/phenotyping of HIV. Two leukophereses
(removal of white cells from the blood) are required. Optional
are lumbar puncture and lymph node biopsy procedures and semen
donation or genital secretion collection for which participants
will be compensated.
Use of Combination
Antiretroviral Therapy to Delineate the Persistence of HIV
Infection (97-I-0082)
Contact: Betsey Herpin,
RN, MSN 1-800-772-5464 ext. 5-7630
This study will attempt to
identify and define potential reservoirs (sites in the body)
of HIV-1 that permit the maintenance of persistent HIV-1 infection
and whether antiviral therapy can reverse the effects of HIV-1
infection. The study is seeking men and women who are HIV
positive with CD4+ cell counts less than 500. Participants
will receive AZT, 3TC, indinavir, and nevirapine therapy for
at least 12 months. All participants will have viral load
testing of the blood, up to 4 leukophereses (removal of white
cells from the blood), and up to 3 lymph node biopsies.
Vaccine
Evaluation of an
HIV-1 DNA Vaccine Encoding a Modified Gag-Pol in Uninfected
Adult Volunteers (01-I-0079)
Contact: Grace Kelly,
RN 1-800-772-5464 ext. 5-7744
The vaccine in this trial,
VRC 4302, is classified as a genetic vaccine. Genetic vaccines
contain the genes (hereditary material) which direct the production
of the proteins of the HIV virus. VRC 4302 contains the gene
for the gag and pol proteins of HIV. It is important to know
that you cannot catch HIV or AIDS from this vaccine. Volunteers
will be randomized in a blinded manner to receive either active
vaccine (at one of 3 doses, 0.5 mg, 1.5 mg or 4.0 mg) or vehicle
(“control”) alone. Participants will receive VRC 4302 by intramuscular
injection once a month for 3 months. The injection is given
using a needleless injection device. A total of approximately
21 individuals will be evaluated. Volunteers will be evaluated
over the course of one year (approximately 15 visits).
Hepatitis
Study of the Safety and
Efficacy of the Addition of Adefovir Dipivoxil to Lamivudine
for the Treatment of Chronic Hepatitis B in HIV-infected and
HIV-uninfected Patients (01-I-0239)
This is a randomized placebo-controlled
study of the safety and efficacy of the addition of ADV to
lamivudine for the treatment of hepatitis B in both HIV positive
and negative persons who have persistent HBV viremia and active
HBV despite at least a year of lamivudine therapy. Subjects
will be randomly allocated to receive either adefovir 10 mg
daily or matching placebo. The study duration is 48 weeks
with possible open-label ADV extension. Some travel costs
will be reimbursed.
Adefovir for Hepatitis
B in Patients with HIV Infection (01-I-0134)
This is a single-arm,
open-label study of the addition of adefovir at 10 mg/day
to lamivudine for the treatment of hepatitis B in people who
have HIV infection, HBV viremia of at least 1,000,000 copies/mL,
and decompensated HBV-associated liver disease. Participants
must have been taking lamivudine (Epivir) for at least the
past year and may not have hepatitis C or D or other active
serious systemic infections.
Visit the web site: www.niaid.nih.gov/hivclinic
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