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

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.

Study Overview

• Status: Completed
• Conditions: HIV Infection

• Study Type: Observational
• Enrollment (Actual): 511

Contacts and Locations

Study Locations

• Côte D'Ivoire
  • Abidjan, Côte D'Ivoire
    • Centre Médical du Suivi des Donneurs de Sang (Blood Bank Medical Centre)
  • Abidjan, Côte D'Ivoire
    • Centre National de Transfusion Sanguine (National Blood Transfusion Centre)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Natural history of HIV infection in Sub-Saharan Africa	Plasmatic HIV viral load and CD4 measured every six months and incidence of morbidity events associated with AIDS	12 months after ART initiation

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Estimate the probability of disease progression after HIV seroconversion	Disease progression will be estimated with CD4 cell loss and time from seroconversion to clinical AIDS, death and antiretroviral therapy initiation	12 months after ART initiation
Evolution of markers of HIV infection and immunity	CD4 count, immune activation, plasma HIV-RNA intracellular, HIV-DNA	12 months after ART initiation
Viral genetic diversity description	biomolecular analysis of HIV-1	Inclusion (J0)
Primary resistance to antiretroviral treatment	Frequency of primary resistance to antiretroviral treatment (genotyping)	Inclusion (J0)
Metabolic and lipodystrophic disorders	Metabolic analysis (Total Cholesterol, HDL and LDL, Triglycerides) and lipodystrophia measurements	12 months after ART initiation
Incidence of pregnancies	Occurence of pregnancies	12 months after ART initiation
T lymphocytes activation and evolution in seroconverters	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	Inclusion
T lymphocytes activation and evolution in seroconverters	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	12 months after ART initiation

Collaborators and Investigators

• Sponsor: ANRS, Emerging Infectious Diseases
• 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

Publications and helpful links

Helpful Links

• Sponsor site
• Methodology centre site

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 1997
• Primary Completion (Actual): February 1, 2014
• Study Completion (Actual): September 1, 2018

Study Registration Dates

• First Submitted: August 5, 2013
• First Submitted That Met QC Criteria: August 5, 2013
• First Posted (Estimate): August 6, 2013

Study Record Updates

• Last Update Posted (Actual): June 11, 2021
• Last Update Submitted That Met QC Criteria: June 10, 2021
• Last Verified: June 1, 2021

More Information

Terms related to this study

• Keywords: HIV; Cohort; Disease progression; Côte d'Ivoire; Early HIV infection
• Additional Relevant MeSH Terms: Pathologic Processes; RNA Virus Infections; Virus Diseases; Blood-Borne Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; Immunologic Deficiency Syndromes; Immune System Diseases; Disease Attributes; Slow Virus Diseases; HIV Infections; Infections; Communicable Diseases; Acquired Immunodeficiency Syndrome
• Other Study ID Numbers: ANRS 1220/12277 PRECO-CI