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Co-adaptation Between Human Immunodeficiency Virus (HIV) and Cluster of Differentiation 8 (CD8) Cellular Immunity ("ImmunoCo27")

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ClinicalTrials.gov Identifier: NCT02886416
Recruitment Status : Completed
First Posted : September 1, 2016
Last Update Posted : September 28, 2018
Sponsor:
Information provided by (Responsible Party):
ANRS, Emerging Infectious Diseases

Tracking Information
First Submitted Date August 29, 2016
First Posted Date September 1, 2016
Last Update Posted Date September 28, 2018
Actual Study Start Date August 2016
Actual Primary Completion Date April 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: August 29, 2016)
Longitudinal study of the co-adaptation of HIV and immune host factors in 28 patients with HIV followed for 27 years. [ Time Frame: 27 years ]
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Co-adaptation Between Human Immunodeficiency Virus (HIV) and Cluster of Differentiation 8 (CD8) Cellular Immunity
Official Title Study of Co-adaptation Between Human Immunodeficiency Virus (HIV) and Cluster of Differentiation 8 (CD8) Cellular Immunity, for 27 Years of Natural Evolution and on Treatment
Brief Summary The objective is to characterize the viral evolution and viral factors determining HIV virulence, the evolution of the HIV reservoir in PBMC and the co-evolution of anti-HIV CD8 T cell repertoires. The coordinated study of virus evolution, host responses and identification of genetic determinants of virulence should allow to better understand mechanisms of HIV pathogenicity and persistence of mutations in viral reservoirs.
Detailed Description The importance of the still unmet challenges raised by researches on the eradication of the HIV reservoirs and by the need for developing efficient vaccines against HIV, imposes a much deeper understanding the molecular mechanisms regulating the co-evolution and the co-adaptation between HIV and its host during the natural course of the disease an during treatment. The unique cell collection established 27 years ago in an ANRS cohort (ImmunoCo) and the new methods of ultra deep sequencing, or " next generation sequencing", allow to produce innovative analysis of the HIV variability and of reservoirs as well as of the repertoires used by CD8 T cells responses to provide new insights in the very long term relationships between the virus and its host. The objective is to progress at unprecedented levels in the understanding of these mechanisms thanks to the unique opportunity offered by this Immunoco cohort initially composed of 152 patients infected by HIV, most of them untreated when recruited from 1991 to 97 at Pitié-Salpêtrière hospital, with 28 subjects still followed in this hospital and efficiently treated for the last 15 years. The ImmunoCo cohort had initially been set up to study the characteristics of the cytotoxic T lymphocyte (CTL) responses to HIV with disease progression. This exceptional and still available 1991-97 cell collection enriched of extra samples from 1988 to nowadays, allow us to perform a retrospective longitudinal analysis over 27 years in the 28 patients still followed-up, with a new blood sampling in 2016. The project involves 5 highly experienced teams and aims at characterizing in parallel: 1) the viral evolution and viral factors determining virulence, as markers predicting progression of infection, by performing an ultra deep sequencing of the whole HIV genome and of viral variants archived in blood mononuclear cells (PBMC), and 2) the evolution of the reservoir in PBMC and of the distribution of variants archived in those reservoirs over time, in relationship with exposure to the various selective pressures due to CTL or antiretroviral therapy (ART), 3) the co-evolution of anti-HIV CD8 T cell repertoires: the hypothesis is that the emergence of new CD8 T clonotypes displaying a great sensibility for variant antigens, or a cross-reactivity able to recognize similarly wild-type and mutant epitopes allow an efficient long term control of viral replication, and that cell loss by clonal exhaustion is associated to disease progression. The coordinated study of virus evolution, host responses and identification of genetic determinants of virulence should allow to better understand mechanisms of HIV pathogenicity and persistence of mutations in viral reservoirs, especially of defective mutants or resistant mutants to ART, as well as the co-adaptation of CD8 T cell repertoires and of viral variability determining the capacities of viral control by anti-HIV CD8 T cells. Altogether these results should open new strategies for inhibiting viral replication and for controlling viral reservoirs for therapeutic and vaccinal perspectives.
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Other
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples With DNA
Description:
frozen PBMC
Sampling Method Non-Probability Sample
Study Population Patients infected with HIV included in the ANRS Immunoco cohort.
Condition HIV Infection
Intervention Other: Non interventional study
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: September 27, 2018)
22
Original Estimated Enrollment
 (submitted: August 29, 2016)
28
Actual Study Completion Date April 2017
Actual Primary Completion Date April 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • Initially included in the ANRS Immunoco cohort and still followed in the Infectious Diseases department by Pr C. Katlama team

Exclusion Criteria:

  • None
Sex/Gender
Sexes Eligible for Study: All
Ages 40 Years to 95 Years   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number NCT02886416
Other Study ID Numbers ANRS EP60
2016-A00400-51 ( Other Identifier: ANSM )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement
Plan to Share IPD: Yes
Plan Description: Scientific publication
Responsible Party ANRS, Emerging Infectious Diseases
Study Sponsor ANRS, Emerging Infectious Diseases
Collaborators Not Provided
Investigators
Principal Investigator: Victor Appay, phD INSERM S1136
PRS Account ANRS, Emerging Infectious Diseases
Verification Date September 2016