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

Study Overview
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Brief Summary
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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.

Official Title
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Research Platform  Early Identification and Treatment of Early HIV Infection in Côte d'Ivoire 

Conditions
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HIV Infection

Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| HIV+ patients with an estimated date of seroconversion<br>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?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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HIV, Cohort, Early HIV infection, Côte d'Ivoire, Disease progression