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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified August 2013 by French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS).
Recruitment status was:  Recruiting
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: NA
Last verified: August 2013
History: No changes posted
August 5, 2013
August 5, 2013
June 1997
December 2014   (Final data collection date for primary outcome measure)
Natural history of HIV infection in Sub-Saharan Africa [ Time Frame: 12 months after ART initiation ]
Plasmatic HIV viral load and CD4 measured every six months and incidence of morbidity events associated with AIDS
Same as current
No Changes Posted
  • Estimate the probability of disease progression after HIV seroconversion [ Time Frame: 12 months after ART initiation ]
    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 ]
    CD4 count, immune activation, plasma HIV-RNA intracellular, HIV-DNA
  • Viral genetic diversity description [ Time Frame: Inclusion (J0) ]
    biomolecular analysis of HIV-1
  • Primary resistance to antiretroviral treatment [ Time Frame: Inclusion (J0) ]
    Frequency of primary resistance to antiretroviral treatment (genotyping)
  • Metabolic and lipodystrophic disorders [ Time Frame: 12 months after ART initiation ]
    Metabolic analysis (Total Cholesterol, HDL and LDL, Triglycerides) and lipodystrophia measurements
  • Incidence of pregnancies [ Time Frame: 12 months after ART initiation ]
    Occurence of pregnancies
  • T lymphocytes activation and evolution in seroconverters [ Time Frame: Inclusion ]
    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 ]
    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
Same as current
Not Provided
Not Provided
 
Early Identification and Treatment of Early HIV Infection in Côte d'Ivoire
Research Platform " Early Identification and Treatment of Early HIV Infection in Côte d'Ivoire "
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.
Not Provided
Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Retention:   Samples With DNA
Description:
Plasma and whole blood for PBMC preparation
Non-Probability Sample
All HIV infected individuals that will have had a contact with the Blood Bank Medical Center since 1992.
HIV Infection
Not Provided
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.
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Unknown status
564
December 2014
December 2014   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Côte D'Ivoire
 
 
NCT01917175
ANRS 1220/12277 PRECO-CI
No
Not Provided
Not Provided
French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS)
French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS)
Not Provided
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
French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS)
August 2013

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