NCT00402142

Brief Summary

  1. 1.To study the efficacy of a therapeutic HIV vaccine consisting of autologous myeloid dendritic cells pulsed ex vivo with high doses of inactivated autologous HIV-1, in HIV-1 infected patients in a very early stages of the disease (CD4 \> 450 x 10 6 /L).
  2. 2.To analyze the HIV-1 humoral and cellular immune responses induced by this immune-based therapy.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P75+ for phase_1 hiv-infections

Timeline
Completed

Started Nov 2006

Longer than P75 for phase_1 hiv-infections

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, 2006

Completed
16 days until next milestone

First Submitted

Initial submission to the registry

November 17, 2006

Completed
5 days until next milestone

First Posted

Study publicly available on registry

November 22, 2006

Completed
5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2011

Completed
Last Updated

February 26, 2014

Status Verified

February 1, 2014

Enrollment Period

5.1 years

First QC Date

November 17, 2006

Last Update Submit

February 25, 2014

Conditions

HIV Infections

Keywords

HIV InfectionDendritic cell vaccineAutologous virusHeat inactivatedHIV Therapeutic Vaccine

Outcome Measures

Primary Outcomes (1)

  • Comparison of steady state viremia (so-called viral set point) after 6-12 months after vaccination with viremia before HAART.

    6 and 12 months

Secondary Outcomes (6)

  • Proportion with evidence of HIV-specific CTL comparing end of immune-based therapy, and end of trial (week 48) with start of immune-based therapy.

    6 and 12 months

  • Proportion with evidence of HIV-specific T-cell proliferative response comparing end of immune-based therapy, and end of trial (week 48) with start of immune-based therapy.

    6 and 12 months

  • Proportion with evidence of HIV-specific neutralizing activity of serum comparing end of immune-based therapy, and end of trial (week 48) with start of immune-based therapy.

    6 and 12 months

  • HIV-1 specific CTL responses in lymphoid tissue

    0 and 6 months

  • DC Migration

    0 and 2 weeks

  • +1 more secondary outcomes

Study Arms (5)

Pulsed dendritic cells untreated patients

ACTIVE COMPARATOR

Untreated patients receiving a dendritic cell based vaccine pulsed with autologous heat iactivated virus

Biological: Dendritic cell vaccine

non pulsed dendritic cells untreated patients

PLACEBO COMPARATOR
Biological: non pulsed dendritic cell untreated patients

pulsed dendritic cell treated patient

ACTIVE COMPARATOR

treated patients will be immunized with a dendritic cell vaccine pulsed with heat inactivated autologous virus immediately before art interruption

Biological: pulsed dendritic cell vaccine

pulsed dendritic cell in treated patients

ACTIVE COMPARATOR

patients will be immunized with a dendritic cell vaccine pulsed with heat inactivted autologous virus immediately after interruption of art

Biological: dendritic cell vaccine

non pulsed dendritic cells

PLACEBO COMPARATOR
Biological: non pulsed dendritic cell vaccine

Interventions

dendritic cell vaccineBIOLOGICAL

107 DC subcutaneous 3 doses every 2 weeks

Pulsed dendritic cells untreated patients
non pulsed dendritic cell untreated patientsBIOLOGICAL

107 DC subcutaneous 3 doses every 2 weeks

non pulsed dendritic cells untreated patients
pulsed dendritic cell vaccineBIOLOGICAL

107 DC subcutaneous 3 doses every 2 weeks

pulsed dendritic cell treated patient
non pulsed dendritic cell vaccineBIOLOGICAL

107 DC subcutaneous 3 doses every 2 weeks

non pulsed dendritic cells

Eligibility Criteria

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

You may qualify if:

  • Confirmed HIV infection
  • CD4 \> 450 x 10 6 /L
  • baseline VL \>10,000 c/ml before any HAART
  • Part I, patients off HAART at least during 6 months
  • Part II, Patients on HAART with PVL \< 200 copies/ml at least during 6 months
  • Written informed consent .

You may not qualify if:

  • Patients with failure to HAART
  • Patients with B or C symptoms (CDC classification 1993).
  • Age \< 18 years old.
  • Pregnant or breastfeeding women
  • Patients with baseline creatinin \> 2.5 mg/dl
  • Patients with baseline GOT/GPT \> 250 UI/L

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital Clínic

Barcelona, Barcelona, 08036, Spain

Location

Related Publications (5)

  • Garcia F, Lejeune M, Climent N, Gil C, Alcami J, Morente V, Alos L, Ruiz A, Setoain J, Fumero E, Castro P, Lopez A, Cruceta A, Piera C, Florence E, Pereira A, Libois A, Gonzalez N, Guila M, Caballero M, Lomena F, Joseph J, Miro JM, Pumarola T, Plana M, Gatell JM, Gallart T. Therapeutic immunization with dendritic cells loaded with heat-inactivated autologous HIV-1 in patients with chronic HIV-1 infection. J Infect Dis. 2005 May 15;191(10):1680-5. doi: 10.1086/429340. Epub 2005 Apr 11.

    PMID: 15838795BACKGROUND

  • Garcia F, Climent N, Guardo AC, Gil C, Leon A, Autran B, Lifson JD, Martinez-Picado J, Dalmau J, Clotet B, Gatell JM, Plana M, Gallart T; DCV2/MANON07-ORVACS Study Group. A dendritic cell-based vaccine elicits T cell responses associated with control of HIV-1 replication. Sci Transl Med. 2013 Jan 2;5(166):166ra2. doi: 10.1126/scitranslmed.3004682.

    PMID: 23283367RESULT

  • Garcia F, Climent N, Assoumou L, Gil C, Gonzalez N, Alcami J, Leon A, Romeu J, Dalmau J, Martinez-Picado J, Lifson J, Autran B, Costagliola D, Clotet B, Gatell JM, Plana M, Gallart T; DCV2/MANON07- AIDS Vaccine Research Objective Study Group. A therapeutic dendritic cell-based vaccine for HIV-1 infection. J Infect Dis. 2011 Feb 15;203(4):473-8. doi: 10.1093/infdis/jiq077. Epub 2011 Jan 13.

    PMID: 21233310RESULT

  • Andres C, Plana M, Guardo AC, Alvarez-Fernandez C, Climent N, Gallart T, Leon A, Clotet B, Autran B, Chomont N, Gatell JM, Sanchez-Palomino S, Garcia F. HIV-1 Reservoir Dynamics after Vaccination and Antiretroviral Therapy Interruption Are Associated with Dendritic Cell Vaccine-Induced T Cell Responses. J Virol. 2015 Sep;89(18):9189-99. doi: 10.1128/JVI.01062-15. Epub 2015 Jun 24.

    PMID: 26109727DERIVED

  • Gil C, Climent N, Garcia F, Hurtado C, Nieto-Marquez S, Leon A, Garcia MT, Rovira C, Miralles L, Dalmau J, Pumarola T, Almela M, Martinez-Picado J, Lifson JD, Zamora L, Miro JM, Brander C, Clotet B, Gallart T, Gatell JM. Ex vivo production of autologous whole inactivated HIV-1 for clinical use in therapeutic vaccines. Vaccine. 2011 Aug 5;29(34):5711-24. doi: 10.1016/j.vaccine.2011.05.096. Epub 2011 Jun 14.

    PMID: 21679735DERIVED

MeSH Terms

Conditions

HIV Infections

Condition Hierarchy (Ancestors)

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

Study Officials

  • Felipe García, MD, PhD

    Hospital Clínic

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

November 17, 2006

First Posted

November 22, 2006

Study Start

November 1, 2006

Primary Completion

December 1, 2011

Study Completion

December 1, 2011

Last Updated

February 26, 2014

Record last verified: 2014-02

Locations

ES(1)