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

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ClinicalTrials.gov Identifier: NCT01917175
Recruitment Status : Unknown
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
First Posted : August 6, 2013
Last Update Posted : August 6, 2013
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)

Study Description
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:
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 or disease
HIV Infection

Study Design
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Study Type : Observational
Estimated Enrollment : 564 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Research Platform " Early Identification and Treatment of Early HIV Infection in Côte d'Ivoire "
Study Start Date : June 1997
Estimated Primary Completion Date : December 2014
Estimated Study Completion Date : December 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS
U.S. FDA Resources

Groups and Cohorts
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Group/Cohort
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.


Outcome Measures
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Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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

  2. 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

  3. Viral genetic diversity description [ Time Frame: Inclusion (J0) ]
    biomolecular analysis of HIV-1

  4. Primary resistance to antiretroviral treatment [ Time Frame: Inclusion (J0) ]
    Frequency of primary resistance to antiretroviral treatment (genotyping)

  5. Metabolic and lipodystrophic disorders [ Time Frame: 12 months after ART initiation ]
    Metabolic analysis (Total Cholesterol, HDL and LDL, Triglycerides) and lipodystrophia measurements

  6. Incidence of pregnancies [ Time Frame: 12 months after ART initiation ]
    Occurence of pregnancies

  7. 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

  8. 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


Biospecimen Retention:   Samples With DNA
Plasma and whole blood for PBMC preparation

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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 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   
Centre National de Transfusion Sanguine (National Blood Transfusion Centre) Recruiting
Abidjan, Côte D'Ivoire
Contact: Seidou Konaté, MD    +22521355723    plasmaci@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
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Additional Information:
Sponsor site  This link exits the ClinicalTrials.gov site
Methodology centre site  This link exits the ClinicalTrials.gov site

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
First Posted: August 6, 2013    Key Record Dates
Last Update Posted: August 6, 2013
Last Verified: August 2013

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:
Infection
Communicable Diseases
HIV Infections
Acquired Immunodeficiency Syndrome
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