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Completed

NCT Number: NCT01917175

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

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.

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Key information

Conditions

HIV Infection Blood-Borne Infections Communicable Diseases Disease Attributes Disease Progression Genital Diseases HIV Infections Immune System Diseases Immunologic Deficiency Syndromes Infections Lentivirus Infections Pathologic Processes Pathological Conditions, Signs and Symptoms RNA Virus Infections Retroviridae Infections Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Urogenital Diseases Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Centre Médical du Suivi des Donneurs de Sang (Blood Bank Medical Centre), Abidjan, Côte d’Ivoire

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 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

  1. Estimate the probability of disease progression after HIV seroconversion

    Time frame: 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

  2. Evolution of markers of HIV infection and immunity

    Time frame: 12 months after ART initiation

    CD4 count, immune activation, plasma HIV-RNA intracellular, HIV-DNA

  3. Viral genetic diversity description

    Time frame: Inclusion (J0)

    biomolecular analysis of HIV-1

  4. Primary resistance to antiretroviral treatment

    Time frame: Inclusion (J0)

    Frequency of primary resistance to antiretroviral treatment (genotyping)

  5. Metabolic and lipodystrophic disorders

    Time frame: 12 months after ART initiation

    Metabolic analysis (Total Cholesterol, HDL and LDL, Triglycerides) and lipodystrophia measurements

  6. Incidence of pregnancies

    Time frame: 12 months after ART initiation

    Occurence of pregnancies

  7. T lymphocytes activation and evolution in seroconverters

    Time frame: Inclusion

    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

  8. T lymphocytes activation and evolution in seroconverters

    Time frame: 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

Sponsors and collaborators

Lead sponsor

ANRS, Emerging Infectious Diseases

Other Gov

Registry information

Official study title

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

Acronym: PRECO-CI

Important dates

Study start
1997
Primary completion
2014
Study completion
2018
First posted
Aug 6, 2013
Registry last updated
Jun 11, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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