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Clinical Trials/NCT01917175
NCT01917175CompletedNot Applicable

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

ANRS, Emerging Infectious Diseases2 sites in 1 country511 target enrollmentStarted: June 1997Last updated:
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Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
511
Locations
2
Primary Endpoint
Natural history of HIV infection in Sub-Saharan Africa
Study OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

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.

Study Design

Study Type
Observational
Observational Model
Cohort
Time Perspective
Prospective

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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

Outcomes

Primary Outcomes

Natural history of HIV infection in Sub-Saharan Africa

Time Frame: 12 months after ART initiation

Plasmatic HIV viral load and CD4 measured every six months and incidence of morbidity events associated with AIDS

Secondary Outcomes

  • Evolution of markers of HIV infection and immunity(12 months after ART initiation)
  • Metabolic and lipodystrophic disorders(12 months after ART initiation)
  • Incidence of pregnancies(12 months after ART initiation)
  • Estimate the probability of disease progression after HIV seroconversion(12 months after ART initiation)
  • Viral genetic diversity description(Inclusion (J0))
  • Primary resistance to antiretroviral treatment(Inclusion (J0))
  • T lymphocytes activation and evolution in seroconverters(12 months after ART initiation)

Investigators

Sponsor Class
Other Gov
Responsible Party
Sponsor

Study Sites (2)

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