NCT00796770

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
19

participants targeted

Target at P25-P50 for phase_1 hiv

Timeline
Completed

Started Nov 2008

Longer than P75 for phase_1 hiv

Geographic Reach
1 country

1 active site

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

November 1, 2008

Completed
20 days until next milestone

First Submitted

Initial submission to the registry

November 21, 2008

Completed
3 days until next milestone

First Posted

Study publicly available on registry

November 24, 2008

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2011

Completed
Last Updated

June 12, 2017

Status Verified

June 1, 2017

Enrollment Period

2.8 years

First QC Date

November 21, 2008

Last Update Submit

June 9, 2017

Conditions

HIV

Keywords

HIVVaccineHAARTHIV-1AIDSDendritic CellsDALIA

Outcome Measures

Primary Outcomes (1)

  • 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.

    May 2010

Secondary Outcomes (1)

  • To evaluate immune responses using several defined assays as well as viral and CD4+ T cell status

    May 2010

Study Arms (1)

Dendritic Cell Vaccine

EXPERIMENTAL

Autologous dendritic cells generated using GM-CSF and interferon alpha, loaded with HIV lipopeptides and activated with lipopolysaccharide

Biological: Dendritic Cell Vaccine

Interventions

Dendritic Cell VaccineBIOLOGICAL

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.

Dendritic Cell Vaccine

Eligibility Criteria

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

You may qualify if:

  • ≥ 18 years old
  • written informed consent
  • HIV1 infection documented by any licensed ELISA test kit and confirmed by Western Blot at anytime prior to study entry
  • 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)
  • 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)
  • nadir CD4+ T cell counts \> 300 cells/mm3 prior HAART
  • 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)
  • no history of CDC class C event (Appendix 2)
  • no vaccination in the last 3 months
  • blood cells and chemistry:
  • neutrophils ≥ 1,000/mm3
  • platelets ≥ 100,000/mm3
  • hemoglobin ≥ 10 g/dl
  • creatinin ≤ 1.5 x N
  • ASAT, ALAT, conjugated bilirubin ≤ 2.5 x N
  • +1 more criteria

You may not qualify if:

  • Nadir CD4+ T cell counts \< 300 cells/mm3 prior HAART
  • pregnant or lactating woman
  • any prior chemotherapy treatment
  • interferon alpha (IFN-α-2b) or sargramostim (GM-CSF) \< 12 weeks before the beginning of the trial
  • interleukin-2 (IL-2) \<12 weeks before the beginning of the trial,
  • corticosteroids or other immunosuppressive agents \<12 weeks before beginning the trial
  • active asthma and/or on treatment for asthma,
  • 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
  • angina pectoris or with congestive heart failure, with auto-immune disease, or evolutive pulmonary disease, or organ failure
  • active infections including viral hepatitis
  • history of thrombocytopenia
  • chronic hepatitis B or C
  • previous exposure to any HIV experimental vaccine.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Baylor University Medical Center

Dallas, Texas, 75204, United States

Location

Related Publications (2)

  • Alexandre M, Prague M, Lhomme E, Lelievre JD, Wittkop L, Richert L, Levy Y, Thiebaut R. Definition of Virological Endpoints Improving the Design of HIV Cure Strategies Using Analytical Antiretroviral Treatment Interruption. Clin Infect Dis. 2024 Dec 17;79(6):1447-1457. doi: 10.1093/cid/ciae235.

    PMID: 38819800DERIVED

  • Cobb A, Roberts LK, Palucka AK, Mead H, Montes M, Ranganathan R, Burkeholder S, Finholt JP, Blankenship D, King B, Sloan L, Harrod AC, Levy Y, Banchereau J. Development of a HIV-1 lipopeptide antigen pulsed therapeutic dendritic cell vaccine. J Immunol Methods. 2011 Feb 28;365(1-2):27-37. doi: 10.1016/j.jim.2010.11.002. Epub 2010 Nov 18.

    PMID: 21093448DERIVED

MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome

Condition Hierarchy (Ancestors)

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

Study Officials

  • Jacques Banchereau, PhD

    Baylor Research Institute

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 21, 2008

First Posted

November 24, 2008

Study Start

November 1, 2008

Primary Completion

September 1, 2011

Study Completion

September 1, 2011

Last Updated

June 12, 2017

Record last verified: 2017-06

Locations

US(1)