HIV Infections Clinical Trial
Official title:
Substudies of ESPRIT: ESPRIT Influenza Vaccine Substudy (FLUVAC) and ESPRIT Tetanus-Pneumococcal Vaccine Substudy (TEPVAC)
This investigation is a sub-study of the 6-year multinational ESPRIT (Evaluation of
Subcutaneous Proleukin in a Randomized International Trial) protocol. It will compare the
effectiveness of the influenza (FLUVAC) and tetanus-pneumococcal (TEPVAC) vaccines in
HIV-infected patients receiving interleukin-2 (IL-2) plus anti-HIV drugs with those
receiving only anti-HIV drugs. IL-2 is a protein naturally produced by immune cells called
lymphocytes. Lymphocytes from patients with HIV do not produce IL-2 normally. The ESPRIT
trial is evaluating whether HIV-infected patients treated with antiretroviral drugs plus
IL-2 have fewer serious infections and improved survival than those receiving only anti-HIV
drugs.
Participants in this sub-study will be drawn from patients enrolled in ESPRIT. They must be
18 years of age or older, have HIV infection with no symptoms of significant HIV illness.
They will be vaccinated against either influenza or tetanus and pneumococcus, as follows:
FLUVAC
Potentially eligible patients will be screened for the FLUVAC study during an ESPRIT
follow-up visit. Those who are eligible and agree to participate will have 10 ml (1
tablespoon) of blood drawn to assess baseline antibody levels and then receive the
vaccination. They will be vaccinated annually for 3 years. A blood sample (10 ml) will be
drawn 1 month after each vaccination to measure the immune response. Some of the blood drawn
for this study will be stored and used for research purposes.
TEPVAC
Participants will have 10 ml of blood drawn to assess their baseline antibody levels. They
will receive two vaccinations (tetanus and pneumococcus) 12 months after enrolling in ESPRIT
and another two vaccinations 24 months after enrollment. A blood sample (10 ml) will be
drawn 1 month after each vaccination to measure the immune response. Some of the blood drawn
for this study will be stored and used for research purposes.
Evaluation of Subcutaneous Proleukin in a Randomized International Trial (ESPRIT) is a 4,000 patient, 6-year study investigating the clinical effect of interleukin-2 (IL-2) in patients with HIV infection. Because of the size and duration of this study, substudies to the parent trial are being performed in order to improve the knowledge regarding the use of IL-2 in HIV-infected individuals and to enhance the overall scientific output of this international effort. This protocol will serve as the umbrella under which the ESPRIT substudies will be performed at the National Institutes of Health Clinical Center. ;
Primary Purpose: Treatment
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