Trial record 6 of 32 for:    " July 10, 2013":" August 09, 2013"[FIRST-RECEIVED-DATE]AND HIV[CONDITION]

Early Identification and Treatment of Early HIV Infection in Côte d'Ivoire (PRECO-CI)

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2013 by French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS)
Sponsor:
Information provided by (Responsible Party):
French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS)
ClinicalTrials.gov Identifier:
NCT01917175
First received: August 5, 2013
Last updated: August 5, 2013
Last verified: August 2013
  Purpose

Set-up of a biobank for patients with an estimated date of infection seroconverters: store plasma and cells samples at initial contact and during follow-up for future analysis and analysis in international collaborative cohort seroconverters.


Condition
HIV Infection

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Research Platform " Early Identification and Treatment of Early HIV Infection in Côte d'Ivoire "

Resource links provided by NLM:


Further study details as provided by French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS):

Primary Outcome Measures:
  • Natural history of HIV infection in Sub-Saharan Africa [ Time Frame: 12 months after ART initiation ] [ Designated as safety issue: No ]
    Plasmatic HIV viral load and CD4 measured every six months and incidence of morbidity events associated with AIDS


Secondary Outcome Measures:
  • Estimate the probability of disease progression after HIV seroconversion [ Time Frame: 12 months after ART initiation ] [ Designated as safety issue: No ]
    Disease progression will be estimated with CD4 cell loss and time from seroconversion to clinical AIDS, death and antiretroviral therapy initiation

  • Evolution of markers of HIV infection and immunity [ Time Frame: 12 months after ART initiation ] [ Designated as safety issue: No ]
    CD4 count, immune activation, plasma HIV-RNA intracellular, HIV-DNA

  • Viral genetic diversity description [ Time Frame: Inclusion (J0) ] [ Designated as safety issue: No ]
    biomolecular analysis of HIV-1

  • Primary resistance to antiretroviral treatment [ Time Frame: Inclusion (J0) ] [ Designated as safety issue: No ]
    Frequency of primary resistance to antiretroviral treatment (genotyping)

  • Metabolic and lipodystrophic disorders [ Time Frame: 12 months after ART initiation ] [ Designated as safety issue: No ]
    Metabolic analysis (Total Cholesterol, HDL and LDL, Triglycerides) and lipodystrophia measurements

  • Incidence of pregnancies [ Time Frame: 12 months after ART initiation ] [ Designated as safety issue: No ]
    Occurence of pregnancies

  • T lymphocytes activation and evolution in seroconverters [ Time Frame: Inclusion ] [ Designated as safety issue: No ]
    Define parameters of activation of T lymphocytes and their evolution since primo-infection among individuals recently infected in West Africa; Expression of markers CD38, HLA-DR, CD28 and CD127 on CD4 and CD8 T cells by flux cytometry

  • T lymphocytes activation and evolution in seroconverters [ Time Frame: 12 months after ART initiation ] [ Designated as safety issue: No ]
    Define parameters of activation of T lymphocytes and their evolution since primo-infection among individuals recently infected in West Africa; Expression of markers CD38, HLA-DR, CD28 and CD127 on CD4 and CD8 T cells by flux cytometry


Biospecimen Retention:   Samples With DNA

Plasma and whole blood for PBMC preparation


Estimated Enrollment: 564
Study Start Date: June 1997
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts
HIV+ patients with an estimated date of seroconversion
It was estimated that 564 individuals, will be enrolled at the Blood Bank Medical Centre, including 364 individuals already followed-up (former PRIMOCI ANRS 1220 cohort started in 1997) and 200 newly enrolled individuals in this study.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

All HIV infected individuals that will have had a contact with the Blood Bank Medical Center since 1992.

Criteria

Inclusion Criteria:

  • patients included in the last Primo-CI ANRS 1220 protocol
  • All HIV infected individuals diagnosed during a blood donation with an estimated date of HIV seroconversion that will respect the following criteria: (i) age ≥18 (ii) HIV-1 or HIV-1+2 infected, (iii) HIV-seronegative at the preceding donation; (iv) who returned to the clinic to be informed of their HIV test result (v) with an HIV serology confirmed with two specific tests in two different laboratories (vi) who have never received ART for curative purpose
  • informed on study objectives and have a signed informed consent.

Exclusion Criteria:

  • Patient living outside of Abidjan
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01917175

Contacts
Contact: Albert Minga, MD, PhD +225 21 35 52 78 minga.albert@yahoo.fr
Contact: Patrick Coffie, MD, PhD +225 21 75 59 60 ahuatchi@gmail.com

Locations
Côte D'Ivoire
Centre National de Transfusion Sanguine (National Blood Transfusion Centre) Recruiting
Abidjan, Côte D'Ivoire
Contact: Seidou Konaté, MD    +22521355723    plasmaci@yahoo.fr   
Centre Médical du Suivi des Donneurs de Sang (Blood Bank Medical Centre) Recruiting
Abidjan, Côte D'Ivoire
Contact: Albert Kla Minga, MD, PhD    +225 21 35 52 78    minga.albert@yahoo.fr   
Sponsors and Collaborators
French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS)
Investigators
Principal Investigator: Albert Kla Minga, MD, PhD CMSDS, Abidjan, Côte d'Ivoire
Principal Investigator: Patrick Coffie, MD, PhD Programme PACCI, Abidjan, Côte d'Ivoire
Principal Investigator: Charlotte Lewden, MD, PhD Institut de Santé Publique, d'Epidémiologie et de Développement (ISPED), Bordeaux, France
  More Information

Additional Information:
No publications provided

Responsible Party: French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS)
ClinicalTrials.gov Identifier: NCT01917175     History of Changes
Other Study ID Numbers: ANRS 1220/12277 PRECO-CI
Study First Received: August 5, 2013
Last Updated: August 5, 2013
Health Authority: France: Comité consultatif sur le traitement de l'information en matière de recherche dans le domaine de la santé

Keywords provided by French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS):
HIV
Cohort
Early HIV infection
Côte d'Ivoire
Disease progression

Additional relevant MeSH terms:
HIV Infections
Acquired Immunodeficiency Syndrome
Infection
Communicable Diseases
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases

ClinicalTrials.gov processed this record on September 22, 2014