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

This study has been completed.
Sponsor:
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: May 23, 2013
Last verified: May 2013
  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: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: 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)

Resource links provided by NLM:


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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • To evaluate immune responses using several defined assays as well as viral and CD4+ T cell status [ Time Frame: May 2010 ] [ Designated as safety issue: Yes ]

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:

  1. two consecutive measurements of CD4+ T cell count below 350x10e6 cells/L and/or 25% of total lymphocytes within at least a 2 weeks
  2. an opportunistic infection
  3. a CDC class C-defining event (defined in appendix 2)
  4. 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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
  11. 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
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

No publications provided by Baylor Research Institute

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Baylor Research Institute
ClinicalTrials.gov Identifier: NCT00796770     History of Changes
Other Study ID Numbers: Baylor IRB #008-017
Study First Received: November 21, 2008
Last Updated: May 23, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Baylor Research Institute:
HIV
Vaccine
HAART
HIV-1
AIDS
Dendritic Cells
DALIA

ClinicalTrials.gov processed this record on August 27, 2014