Early Identification and Treatment of Early HIV Infection in Côte d'Ivoire

Completed

• Conditions: HIV Infection

• Registration Number: NCT01917175
• Lead Sponsor: ANRS, Emerging Infectious Diseases

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.

Detailed Description

Not available

Study Timeline

• Study Start: 1997-06
• Study First Submitted: 2013-08-05
• Study First Submitted QC: 2013-08-05
• Study First Posted: 2013-08-06
• Primary Completion: 2014-02
• Study Completion: 2018-09
• Status Verified: 2021-06
• Last Update Submitted: 2021-06-10
• Last Update Posted: 2021-06-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 511

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Natural history of HIV infection in Sub-Saharan Africa	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

Name	Time	Method
Evolution of markers of HIV infection and immunity	12 months after ART initiation	CD4 count, immune activation, plasma HIV-RNA intracellular, HIV-DNA
Metabolic and lipodystrophic disorders	12 months after ART initiation	Metabolic analysis (Total Cholesterol, HDL and LDL, Triglycerides) and lipodystrophia measurements
Incidence of pregnancies	12 months after ART initiation	Occurence of pregnancies
Estimate the probability of disease progression after HIV seroconversion	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
Viral genetic diversity description	Inclusion (J0)	biomolecular analysis of HIV-1
Primary resistance to antiretroviral treatment	Inclusion (J0)	Frequency of primary resistance to antiretroviral treatment (genotyping)
T lymphocytes activation and evolution in seroconverters	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

Trial Locations

Locations (2)

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); 🇨🇮 Abidjan, Côte D'Ivoire