NCT00050726

Brief 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 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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
620

participants targeted

Target at P75+ for phase_2 hiv-infections

Timeline
Completed

Started May 2001

Longer than P75 for phase_2 hiv-infections

Geographic Reach
2 countries

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2001

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

December 17, 2002

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 18, 2002

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2006

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2006

Completed
Last Updated

November 21, 2013

Status Verified

November 1, 2013

Enrollment Period

4.9 years

First QC Date

December 17, 2002

Last Update Submit

November 19, 2013

Conditions

HIV Infections

Keywords

Interleukin-2ImmunotherapyHIVIL-2

Outcome Measures

Primary Outcomes (1)

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

    Month1 post-vaccination.

Interventions

Interleukin-2DRUG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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).
  • 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.

You may not qualify if:

  • 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.)
  • Breast feeding.
  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

National Institutes of Health Clinical Center, 9000 Rockville Pike

Bethesda, Maryland, 20892, United States

Location

Hvidovre University Hospital@@@Copenhagen, Denmark

Copenhagen, 00/00/00, Denmark

Location

Related Links

MeSH Terms

Conditions

HIV Infections

Interventions

Interleukin-2

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System Diseases

Intervention Hierarchy (Ancestors)

InterleukinsCytokinesIntercellular Signaling Peptides and ProteinsPeptidesAmino Acids, Peptides, and ProteinsLymphokinesProteinsBiological Factors

Study Design

Study Type
interventional
Phase
phase 2
Purpose
TREATMENT
Sponsor Type
NIH

Study Record Dates

First Submitted

December 17, 2002

First Posted

December 18, 2002

Study Start

May 1, 2001

Primary Completion

April 1, 2006

Study Completion

April 1, 2006

Last Updated

November 21, 2013

Record last verified: 2013-11

Locations

US(1)DK(1)