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HIV InfectionsPhase 2NCT00050726

Studies of Influenza Vaccine and Tetanus-Pneumococcal Vaccine in HIV-infected Patients Receiving Interleukin-2

A Phase 2 study testing Interleukin-2 in people with HIV Infections, run by National Institute of Allergy and Infectious Diseases (NIAID) at 2 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
HIV Infections
What is being tested?
Interleukin-2
How many people
620 participants
Where
2 sitesin 2 countries
Study dates
May 2001to Apr 2006
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Documentation of HIV-1 infection by any licensed ELISA test and confirmed by a second method (e.g. Western Blot); or any one of the following at any time: detectable HIV p24 antigen, quantifiable plasma HIV RNA, or detectable proviral DNA.
  • Absolute CD4 plus cell count of greater than or equal to 300/mm(3) within 45 days prior to randomization. (For patients who are status post-splenectomy, also a CD4 plus cell percentage greater than or equal to 20%.)
  • No evidence of active clinical disease for at least one year, in the judgement of the clinician, for any AIDS-defining illness (category C., CDC, 1993) or any of the following conditions: extrapulmonary Pneumocystis carinii disease; multi-dermatomal Herpes zoster (greater than or equal to 10 lesions in a non-contiguous site); American trypanosomiasis (Chagas disease) of the CNS; Penicillium marneffii disease; visceral leishmaniasis; non-Hodgkin's lymphoma of any cell-type; Hodgkin's lymphoma; bartonellosis; microsporidiosis (greater than 1 month's duration); nocardiosis; invasive aspergillosis; or Rhodococcus equi disease.
  • Age greater than or equal to 18 years.
  • Laboratory values (within 45 days prior to randomization):
  • AST or ALT less than or equal to 5 x the upper limit of normal (ULN).
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  • Total or direct bilirubin less than 2 x ULN (Patients with hyperbilirubinemia due to Gilbert's syndrome or indinavir therapy may have a serum bilirubin up to 5 x ULN.)
  • Creatinine less than or equal to 2.0 mg/dl (177 micro mol/L).
  • Platelet count greater than or equal to 50,000/mm(3).
  • On or initiating combination antiretroviral therapy at the time of randomization. Antiretroviral therapy can include agents (approved and investigational) administered through routine care or through participation in clinical trials or expanded access programs.
  • Signed informed consent form.
  • Patients eligible for the ESPRIT trial are eligible for the FLUVAC study, except for patients with known allergy to egg, a history of allergic reaction(s) to influenza vaccination or who had an influenza vaccine less than or equal to 6 months after ESPRIT randomization and during the influenza vaccine season, i.e. between September 1st and January 31st on the Northern hemisphere and between February 1st and June 30th on the Southern hemisphere.
  • The inclusion criteria will be the same as the ESPRIT protocol.

Who cannot join

  • Prior rIL-2 therapy.
  • Concurrent malignancy requiring cytotoxic chemotherapy.
  • Use of systemic corticosteroids, immunosuppressants, or cytotoxic agents within 45 days prior to study randomization.
  • Any CNS abnormality that requires ongoing treatment with antiseizure medication.
  • Current or historical autoimmune/Inflammatory diseases including: Inflammatory bowel disease (Chron's disease, ulcerative colitis); Psoriasis; Optic neuritis; or Any autoimmune/inflammatory diseases with potentially life-threatening complications.
  • Pregnancy (For women of childbearing potential, a negative pregnancy test, serum or urine, is required within 14 days prior to randomization.)
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  • Breast feeding.
  • As for the ESPRIT protocol with the addition patients allergic to egg, with a history of allergic reaction(s) to influenza vaccination or who had a influenza vaccine less than or equal to 6 months before inclusion are not eligible for this study.
  • As for the ESPRIT protocol with the additions of patients with a history of allergic reaction to the study vaccines and/or a planned (or given) vaccination with either of the study vaccines within the 12 months following ESPRIT randomization.

Trial locations and contacts

2 sites in 2 countries.

2 sites in 2 countries

United States1 site

  • National Institutes of Health Clinical Center, 9000 Rockville Pike

    Bethesda, Maryland, 20892

Other trials in United States

Denmark1 site

  • Hvidovre University Hospital@@@Copenhagen, Denmark

    Copenhagen, 00/00/00

Other trials in Denmark

About this study

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:

Read more

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.

Read the detailed description

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.

Conditions
HIV Infections
Being tested
Interleukin-2
Keywords
Interleukin-2, Immunotherapy, HIV, IL-2
Medical subject headings
HIV Infections

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Interleukin-2Drug

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. The proportion of patients with eroconversion to one or more vaccine antigens.

    Measured: Month1 post-vaccination.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Dec 2002 (estimated)
  2. Study startMay 2001
  3. Primary completionApr 2006
  4. Study completionApr 2006

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Enrolment
620 participants
IDs, dates and publications
ClinicalTrials.gov ID
NCT00050726
Sponsor's protocol ID
010171
Other IDs
01-I-0171
Status last verified
Nov 2013
First submitted
17 Dec 2002
Last updated
21 Nov 2013
Results posted
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Interleukin-2 in people with HIV Infections, run by National Institute of Allergy and Infectious Diseases (NIAID) at 2 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 13 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 21 Nov 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States, Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The proportion of patients with eroconversion to one or more vaccine antigens. (time frame: Month1 post-vaccination.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00050726.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Nov 2013.

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