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

HIV Infection Clinical Trial

— PRECO-CI  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01917175
• Other study ID #: ANRS 1220/12277 PRECO-CI
• Status: Completed
• Start date: June 1997
• Est. completion date: September 2018

Study information

• Verified date: June 2021
• Source: ANRS, Emerging Infectious Diseases
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 511
• Est. completion date: September 2018
• Est. primary completion date: February 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Acquired Immunodeficiency Syndrome
• Communicable Diseases
• HIV Infection
• HIV Infections
• Infection

Locations

Country	Name	City	State
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)	Abidjan

Sponsors (1)

Lead Sponsor	Collaborator
ANRS, Emerging Infectious Diseases

Country where clinical trial is conducted

Côte D'Ivoire, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	Evolution of markers of HIV infection and immunity	CD4 count, immune activation, plasma HIV-RNA intracellular, HIV-DNA	12 months after ART initiation
Secondary	Viral genetic diversity description	biomolecular analysis of HIV-1	Inclusion (J0)
Secondary	Primary resistance to antiretroviral treatment	Frequency of primary resistance to antiretroviral treatment (genotyping)	Inclusion (J0)
Secondary	Metabolic and lipodystrophic disorders	Metabolic analysis (Total Cholesterol, HDL and LDL, Triglycerides) and lipodystrophia measurements	12 months after ART initiation
Secondary	Incidence of pregnancies	Occurence of pregnancies	12 months after ART initiation
Secondary	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
Secondary	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

External Links

•   Methodology centre site
•   Sponsor site