HIV InfectionPRECO-CINCT01917175
Early Identification and Treatment of Early HIV Infection in Côte d'Ivoire
An observational study of HIV Infection, run by ANRS, Emerging Infectious Diseases at 2 sites in Côte d’Ivoire.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HIV Infection
- How many people
- 511 participants
- Where
- 2 sitesCôte d’Ivoire
- Study dates
- Jun 1997to Sep 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All HIV infected individuals that will have had a contact with the Blood Bank Medical Center since 1992.
Who may be able to join
- 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.
Who cannot join
- Patient living outside of Abidjan
Trial locations and contacts
2 sites in 1 country.
Côte d’Ivoire2 sites
Centre Médical du Suivi des Donneurs de Sang (Blood Bank Medical Centre)
Abidjan
Centre National de Transfusion Sanguine (National Blood Transfusion Centre)
Abidjan
About this study
Official title: Research Platform " 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.
- Conditions
- HIV Infection
- Keywords
- HIV, Cohort, Early HIV infection, Côte d'Ivoire, Disease progression
- Medical subject headings
- HIV Infections, Disease Progression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| HIV+ patients with an estimated date of seroconversion | 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 being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 12 months after ART initiation
Secondary outcomes (8)
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
Measured: 12 months after ART initiation
Evolution of markers of HIV infection and immunity
CD4 count, immune activation, plasma HIV-RNA intracellular, HIV-DNA
Measured: 12 months after ART initiation
Viral genetic diversity description
biomolecular analysis of HIV-1
Measured: Inclusion (J0)
Primary resistance to antiretroviral treatment
Frequency of primary resistance to antiretroviral treatment (genotyping)
Measured: Inclusion (J0)
Metabolic and lipodystrophic disorders
Metabolic analysis (Total Cholesterol, HDL and LDL, Triglycerides) and lipodystrophia measurements
Measured: 12 months after ART initiation
Incidence of pregnancies
Occurence of pregnancies
Measured: 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
Measured: 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
Measured: 12 months after ART initiation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2013 (estimated)
- Study startJun 1997
- Primary completionFeb 2014
- Study completionSep 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIV InfectionStudies of the same condition, open and under way.
- More trials run by ANRS, Emerging Infectious DiseasesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 511 participants (actual)
Sponsor and investigators
- Lead sponsor
- ANRS, Emerging Infectious Diseases
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Albert Kla Minga, MD, PhD, Principal investigator, CMSDS, Abidjan, Côte d'IvoirePatrick Coffie, MD, PhD, Principal investigator, Programme PACCI, Abidjan, Côte d'IvoireCharlotte Lewden, MD, PhD, Principal investigator, Institut de Santé Publique, d'Epidémiologie et de Développement (ISPED), Bordeaux, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01917175
- Sponsor's protocol ID
- ANRS 1220/12277 PRECO-CI
- Acronym
- PRECO-CI
- Status last verified
- Jun 2021
- First submitted
- 5 Aug 2013
- Last updated
- 11 Jun 2021
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Research Platform " Early Identification and Treatment of Early HIV Infection in Côte d'Ivoire "
- ClinicalTrials.gov ID
- NCT01917175
- Acronym / sponsor ID
- PRECO-CI / ANRS 1220/12277 PRECO-CI
- Conditions
- HIV Infection
- Keywords
- HIV, Cohort, Early HIV infection, Côte d'Ivoire, Disease progression
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 511 participants (actual)
- Lead sponsor
- ANRS, Emerging Infectious DiseasesOther government
- Study start
- Jun 1997 (actual)
- Primary completion
- Feb 2014 (actual)
- Study completion
- Sep 2018 (actual)
- First posted
- 6 Aug 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| HIV+ patients with an estimated date of seroconversion | – | –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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All HIV infected individuals that will have had a contact with the Blood Bank Medical Center since 1992.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (1 listed)
- Patient living outside of Abidjan
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
8 secondary outcomes
Estimate the probability of disease progression after HIV seroconversion
Time frame: 12 months after ART initiation
Evolution of markers of HIV infection and immunity
Time frame: 12 months after ART initiation
Viral genetic diversity description
Time frame: Inclusion (J0)
Primary resistance to antiretroviral treatment
Time frame: Inclusion (J0)
Metabolic and lipodystrophic disorders
Time frame: 12 months after ART initiation
Incidence of pregnancies
Time frame: 12 months after ART initiation
T lymphocytes activation and evolution in seroconverters
Time frame: Inclusion
T lymphocytes activation and evolution in seroconverters
Time frame: 12 months after ART initiation
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jun 2021.
- Sponsor siteLink provided by the sponsor.
- Methodology centre siteLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Albert Kla Minga, MD, PhD principal investigator
CMSDS, Abidjan, Côte d'Ivoire
Patrick Coffie, MD, PhD principal investigator
Programme PACCI, Abidjan, Côte d'Ivoire
Charlotte Lewden, MD, PhD principal investigator
Institut de Santé Publique, d'Epidémiologie et de Développement (ISPED), Bordeaux, France
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of HIV Infection, run by ANRS, Emerging Infectious Diseases at 2 sites in Côte d’Ivoire.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Côte d’Ivoire. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Natural history of HIV infection in Sub-Saharan Africa (time frame: 12 months after ART initiation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jun 2021.