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Dendritic Cell Vaccine in HIV-1 Infection

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2008 by Hospital Clinic of Barcelona.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Hospital Clinic of Barcelona
ClinicalTrials.gov Identifier:
NCT00402142
First received: November 17, 2006
Last updated: March 26, 2008
Last verified: March 2008
History of Changes

November 17, 2006
March 26, 2008
November 2006
December 2009   (final data collection date for primary outcome measure)
Comparison of steady state viremia (so-called viral set point) after 6-12 months after vaccination with viremia before HAART.
Same as current
Complete list of historical versions of study NCT00402142 on ClinicalTrials.gov Archive Site
  • 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.
  • 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.
  • 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.
  • HIV-1 specific CTL responses in lymphoid tissue
  • DC Migration
  • Viral load in semen and vaginal secretions
Same as current
Not Provided
Not Provided
 
Dendritic Cell Vaccine in HIV-1 Infection
Phase II Study of Autologous Myeloid Dendritic Cells as a "Cellular Adjuvant" for a Therapeutic HIV-1 Vaccine in Early Stage HIV-1+ Patients (DCV-2).
  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. To analyze the HIV-1 humoral and cellular immune responses induced by this immune-based therapy.

Our group has reported recently the first human trial of 4 therapeutic immunizations at six-week intervals with autologous monocyte-derived dendritic cells (MD-DC) loaded with heat-inactivated autologous HIV in 12 HIV infected patients who had been receiving highly active antiretroviral therapy (HAART) since early chronic infection. Autologous HIV was concentrated from plasma (1,500 ml) obtained by plasmapheresis after a 3-month HAART interruption (STOP1) performed 78 weeks before therapeutic immunizations, and HAART was discontinued again (STOP2) after therapeutic immunization. There was a decrease of set-point plasma viral load (PVL) >= 0.5 log after 24 weeks off HAART in 4 out of 12 patients. In addition, we observed a significant lengthening in mean doubling time of PVL rebound (p= 0.01), and significant decreases in the area under the curve of PVL rebound (p= 0.02) and in the mean peak PVL (p= 0.004) during the 12 weeks after STOP 2 compared with STOP1. This virological response was associated with a weak but significant increase in HIV-1 specific CD4 lymphoproliferative response, and with changes in HIV-1 specific CD8+ T-cell responses in peripheral blood and in lymphoid CTL cells after immunization. In lymphoid tissue, we also observed a trend towards a better control of HIV-1 replication coupled with an increase of CD4+ and CTL cells. No significant virological or immunological changes occurred in controls. We show that a therapeutic vaccine with autologous MD-DC pulsed with heat inactivated autologous HIV-1 is feasible, safe and well tolerated and elicited weak and transient cellular immune responses against HIV, associated with a partial and transient control of HIV replication in some patients.

we hypothesized that a DC vaccine pulsed with higher amount of autologous virus obtained by culture could be more effective than the vaccine we used.
Interventional
Phase 1
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
HIV Infections
Biological: Dendritic cell vaccine
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
60
December 2009
December 2009   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • 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 .

Exclusion Criteria:

  • 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
Both
18 Years and older
No
Contact: Felipe García, MD, PhD 34932275586 fgarcia@clinic.ub.es
Spain
 
NCT00402142
DCV-02/MANON07
Yes
Felipe García, Hospital Clinic
Hospital Clinic of Barcelona
Not Provided
Principal Investigator: Felipe García, MD, PhD Hospital Clínic
Hospital Clinic of Barcelona
March 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP