Clinical trial NCT01917175: Early Identification and Treatment of Early HIV Infection in Côte d'Ivoire
Official title: Research Platform " Early Identification and Treatment of Early HIV Infection in Côte d'Ivoire "
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: HIV Infection
Keywords: HIV
Cohort
Early HIV infection
Côte d'Ivoire
Disease progression
Lead sponsor: ANRS, Emerging Infectious Diseases
Sponsor class: OTHER_GOV
First posted: 2013-08-06
Enrollment: 511
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.


Eligibility 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

Primary outcomes:
measure: Natural history of HIV infection in Sub-Saharan Africa
timeFrame: 12 months after ART initiation
Secondary outcomes:
measure: Estimate the probability of disease progression after HIV seroconversion
timeFrame: 12 months after ART initiation
measure: Evolution of markers of HIV infection and immunity
timeFrame: 12 months after ART initiation
measure: Viral genetic diversity description
timeFrame: Inclusion (J0)
measure: Primary resistance to antiretroviral treatment
timeFrame: Inclusion (J0)
measure: Metabolic and lipodystrophic disorders
timeFrame: 12 months after ART initiation
measure: Incidence of pregnancies
timeFrame: 12 months after ART initiation
measure: T lymphocytes activation and evolution in seroconverters
timeFrame: Inclusion
measure: T lymphocytes activation and evolution in seroconverters
timeFrame: 12 months after ART initiation
Other outcomes:
Locations:
city: Abidjan
country: Côte D'Ivoire
facility: Centre Médical du Suivi des Donneurs de Sang (Blood Bank Medical Centre)
city: Abidjan
country: Côte D'Ivoire
facility: Centre National de Transfusion Sanguine (National Blood Transfusion Centre)
Study officials:
affiliation: CMSDS, Abidjan, Côte d'Ivoire
name: Albert Kla Minga, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Programme PACCI, Abidjan, Côte d'Ivoire
name: Patrick Coffie, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Institut de Santé Publique, d'Epidémiologie et de Développement (ISPED), Bordeaux, France
name: Charlotte Lewden, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: