Clinical Trials

MainTitle

Vaccination of HIV-1 Infected Patients With Dendritic Cells in Addition to Antiretroviral Treatment - (DALIA Trial)

This study has been completed
Sponsor
Baylor Research Institute

Collaborator
French National Agency for Research on AIDS and Viral Hepatitis

Information provided by (Responsible Party)
Baylor Research Institute
ClinicalTrials.gov Identifier
NCT00796770

First received: November 21, 2008
Last updated: June 9, 2017
Last Verified: June 2017
History of Changes
Purpose

Purpose

The purpose of this study is to determine whether the administration of a dendritic cell vaccine is a safe and effective treatment for HIV-1 patients.

Condition Intervention Phase
HIV

Biological : Dendritic Cell Vaccine
Phase 1

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Vaccination of HIV-1 Infected Patients With Ex-vivo Generated Interferon-α Dendritic Cells Loaded With HIV-1 Lipopeptides and Activated With Lipopolysaccharide in Addition to Antiretroviral Treatment: Exploratory Phase I Study-(DALIA Trial)

Further study details as provided by Baylor Research Institute:

Primary Outcome Measures

  • To evaluate the safety of the vaccination schedule at week 24 and the safety of the Analytical Treatment Interruption at week 48 in HIV-1 infected patients. [ Time Frame: May 2010 ]
Secondary Outcome Measures:
  • To evaluate immune responses using several defined assays as well as viral and CD4+ T cell status [ Time Frame: May 2010 ]

Enrollment: 19
Study Start Date: November 2008
Study Completion Date: September 2011
Primary Completion Date: September 2011 (Final data collection date for primary outcome measure)

Arms Assigned Interventions
Experimental: Dendritic Cell Vaccine
Autologous dendritic cells generated using GM-CSF and interferon alpha, loaded with HIV lipopeptides and activated with lipopolysaccharide
Biological: Dendritic Cell Vaccine
  • Biological/Vaccine: Experimental: Dendritic Cell Vaccine Patients will receive 4 doses of the vaccine at weeks 0, 4, 8 and 12. The vaccine will be injected subcutaneously, in 3 separate injection sites in the upper and lower extremities.
At week 24, patients will have HAART treatment interrupted. The HAART treatment will be resumed at week 48 or earlier at any time point if one of the following occur:
  • two consecutive measurements of CD4+ T cell count below 350x10e6 cells/L and/or 25% of total lymphocytes within at least a 2 weeks
  • an opportunistic infection
  • a CDC class C-defining event (defined in appendix 2)
  • a serious non-AIDS defining event.
  • Patients will have follow-up visits on weeks: 22, 24, 25, 26, 27, 28, 32, 36, 40, 44, and 48.

Detailed Description:

The purpose of this study is to determine whether the administration of a dendritic cell vaccine is a safe and effective treatment for HIV-1 patients. This will be a phase I, single-center, study in HIV infected patients. The primary objective is to evaluate safety of the vaccination schedule (from apheresis procedure to week 24) at week 24 and safety of the Analytical Treatment Interruption (ATI; from week 24 to week 48) at week 48 in HIV-1 infected patients who have been receiving antiretroviral therapy for at least 12 months with HIV-1 RNA ≤50 copies/mL and CD4+ T cell counts >500/mm3 at entry in the trial and who received, in addition to anti-retroviral therapy for 24 weeks, vaccination with ex vivo generated interferon-alpha dendritic cells loaded with HIV-1 lipopeptides and activated with lipopolysaccharide (BIIR/ANRS-HIVax-001, the DC vaccine product).

Eligibility

Eligibility

Ages Eligible for Study: 18 Years and older  
Sexes Eligible for Study: All  
Accepts Healthy Volunteers: No  

Criteria

Inclusion Criteria:

    1. ≥ 18 years old
    2. written informed consent
    3. HIV1 infection documented by any licensed ELISA test kit and confirmed by Western Blot at anytime prior to study entry
    4. on treatment with a combination of antiviral drugs (HAART) for at least 12 months, and stable on treatment for at least 3 months prior to enrollment. HAART is defined as an antiretroviral regimen consisting of at least three registered antiretroviral drugs (other than 3 Nucs only and low dose ritonavir used for boosting other protease inhibitors does not count as one of these three antiretroviral agents)
    5. CD4+ T cell counts > 500 cells/mm3 on at least two consecutive measurements (including the screening value) within the previous 6 months prior to enrollment (occasional CD4 cell counts ranging between 450-500 cells/mm3 is permitted)
    6. nadir CD4+ T cell counts > 300 cells/mm3 prior HAART
    7. plasma HIV-RNA ≤ 50 copies/mL on at least two consecutive measurements (including the screening value) within the previous 3 months prior to enrollment (occasional so called 'blips' up to 200 copies/mL are permitted)
    8. no history of CDC class C event (Appendix 2)
    9. no vaccination in the last 3 months
    10. blood cells and chemistry:
        1. neutrophils ≥ 1,000/mm3
        2. platelets ≥ 100,000/mm3
        3. hemoglobin ≥ 10 g/dl
        4. creatinin ≤ 1.5 x N
        5. ASAT, ALAT, conjugated bilirubin ≤ 2.5 x N
      1. Adequate Kidney Function proteinuria ≤ 1 g/l (++)by urinalysis


    Exclusion Criteria:
      1. Nadir CD4+ T cell counts < 300 cells/mm3 prior HAART
      2. pregnant or lactating woman
      3. any prior chemotherapy treatment
      4. interferon alpha (IFN-α-2b) or sargramostim (GM-CSF) < 12 weeks before the beginning of the trial
      5. interleukin-2 (IL-2) <12 weeks before the beginning of the trial,
      6. corticosteroids or other immunosuppressive agents <12 weeks before beginning the trial
      7. active asthma and/or on treatment for asthma,
      8. any history of malignancy (except basal carcinoma of the skin) including any hematologic malignancy or AIDS defining malignancy, such as lymphoproliferative disorder or Kaposi's sarcoma. Patients with Kaposi's sarcoma limited to the skin that disappeared while on HAART therapy, and without requiring any other systemic therapy, 1 year prior to study entry will be eligible to participate
      9. angina pectoris or with congestive heart failure, with auto-immune disease, or evolutive pulmonary disease, or organ failure
      10. active infections including viral hepatitis
      11. history of thrombocytopenia
      12. chronic hepatitis B or C
      13. previous exposure to any HIV experimental vaccine.

    contacts and locations

    Contacts and Locations

    Choosing to participate in a study is an important personal decision.Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.For general information, see Learn About Clinical Studies.

    Please refer to this study by its ClinicalTrials.gov identifier: NCT00796770

    Locations

    United States, Texas
    Baylor University Medical Center
    Dallas, Texas, United States, 75204

    Sponsors and Collaborators

    Baylor Research Institute
    French National Agency for Research on AIDS and Viral Hepatitis

    Investigators

    Principal Investigator: Jacques Banchereau, PhD Baylor Research Institute
    More Information

    More Information


    Responsible Party: Baylor Research Institute  
    ClinicalTrials.gov Identifier: NCT00796770   History of Changes  
    Other Study ID Numbers: 008-017  
    Study First Received: November 21, 2008  
    Last Updated: June 9, 2017  

    Keywords provided by Baylor Research Institute:

    HIV
    Vaccine
    HAART
    HIV-1
    AIDS
    Dendritic Cells
    DALIA

    Additional relevant MeSH terms:
    Vaccines

    ClinicalTrials.gov processed this data on October 15, 2019
    This information is provided by ClinicalTrials.gov.