NCT01793818

Brief Summary

Tat Oyi vaccination on seropositive patients could help their immune system to recognize and neutralize Tat. The neutralization of extra cellular Tat should help the cellular immune response to eliminate HIV-1 infected cells.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Feb 2013

Typical duration for phase_1

Geographic Reach
1 country

1 active site

Status
unknown

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

February 1, 2013

Completed
13 days until next milestone

First Submitted

Initial submission to the registry

February 14, 2013

Completed
4 days until next milestone

First Posted

Study publicly available on registry

February 18, 2013

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2016

Completed
Last Updated

February 10, 2016

Status Verified

February 1, 2016

Enrollment Period

3.1 years

First QC Date

February 14, 2013

Last Update Submit

February 9, 2016

Conditions

AIDS

Keywords

VaccineHIV-1Tat

Outcome Measures

Primary Outcomes (1)

  • Optimal vaccine dose (phase I/II)

    No undesirable events due to vaccination and viremia remaining \< 100 copies/ml after interruption of ART.

    Two years

Secondary Outcomes (1)

  • Optimal Vaccine Dose (phase I/II)

    Two years

Study Arms (4)

Group 1 Phase I/II

PLACEBO COMPARATOR

Three injections with no active principle

Biological: Tat Oyi

Group 2 Phase I/II

ACTIVE COMPARATOR

Three injections of Tat Oyi vaccine containing 11 µg of active principle

Biological: Tat Oyi

Group 3 Phase I/II

ACTIVE COMPARATOR

Three injections Tat Oyi vaccine containing 33 µg of active principle

Biological: Tat Oyi

Group 4 Phase I/II

ACTIVE COMPARATOR

Three injections Tat Oyi vaccine containing 99 µg of active principle

Biological: Tat Oyi

Interventions

Tat OyiBIOLOGICAL

Three injections in the arm

Group 1 Phase I/IIGroup 2 Phase I/IIGroup 3 Phase I/IIGroup 4 Phase I/II

Eligibility Criteria

Age18 Years - 64 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Documented HIV-1 Infection
  • Preferentially, group A patients from CDC classification but no group C patients.
  • HIV-1 patients treated with three antiretroviral drugs since 12 months not changed since three months and having an undetectable viremia since 12 months.
  • HIV-1 Chronic infection defined by a positive HIV-1 ELISA and HIV-1 proteins characterized in a full HIV-1 Western blot. Stable undetectable plasmatic HIV RNA (lower than 40 copies/ml) since 12 months. Lymphocyte CD4 cells higher than 350/mm3 with a NADIR higher than 200/mm3 since 12 months.
  • Patient affiliated to a social security system.
  • No vaccination against influenza or other pathogens since three months.
  • No chemotherapy or treatments with corticosteroid
  • HIV-1 patients being abstinent former drug users or drug users following substitution training.

You may not qualify if:

  • HIV-1 patient protected regarding French law (articles L1121-5, L1121-6, L1121-7, L1121-8 \& L1122-2)
  • No HIV-1 infection
  • Patient infected with HIV-2
  • Patient in HIV-1 primo infection or recently in primo infection
  • Patient in symptomatic primo infection or CD4 cells lower than 200/mm3
  • Women sexually active with no efficient contraception
  • Pregnant women or brass feeding.
  • Patient with an opportunistic infection in the CDC group C.
  • Patient with a cancer and/or under chemotherapy or radiotherapy.
  • Patient with an evolutive psychiatric pathology
  • Patient being HBV and/or HCV positive
  • Patient being ELISA positive for HTLV-1
  • Patient being cirrhotic (Child and Pugh level A, B and C)
  • Patient under criminal investigation
  • Patients with abnormal blood formulation
  • +1 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centre d'Investigation Clinique - Universitary Hospital Centre Conception

Marseille, 13385, France

Location

Related Publications (1)

  • Loret E. HIV extracellular Tat: myth or reality? Curr HIV Res. 2015;13(2):90-7. doi: 10.2174/1570162x12666141202125643.

    PMID: 25439235BACKGROUND

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

  • Isabelle Ravaux, MD

    Assistance Publique Hopitaux De Marseille

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 14, 2013

First Posted

February 18, 2013

Study Start

February 1, 2013

Primary Completion

March 1, 2016

Study Completion

March 1, 2016

Last Updated

February 10, 2016

Record last verified: 2016-02

Data Sharing

IPD Sharing
Will share

Data base (HIV RNA, CD4, CD8, HIV DNA, Tat immune response) and statistical analysis

Locations

FR(1)