NCT06913959

Brief Summary

The aim of the study is to study the genotypic characteristics of HIV-1 non-M circulating in the whole Cameroon and their genetic evolution.

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
220

participants targeted

Target at P75+ for all trials

Timeline
14mo left

Started Jun 2025

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress43%
Jun 2025Jul 2027

First Submitted

Initial submission to the registry

March 31, 2025

Completed
6 days until next milestone

First Posted

Study publicly available on registry

April 6, 2025

Completed
3 months until next milestone

Study Start

First participant enrolled

June 30, 2025

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2027

Last Updated

April 8, 2025

Status Verified

April 1, 2025

Enrollment Period

2 years

First QC Date

March 31, 2025

Last Update Submit

April 4, 2025

Conditions

Keywords

HIV genetic diversityHIV-1 non-M variants

Outcome Measures

Primary Outcomes (1)

  • Prevalence of non-M HIV-1 in Cameroon

    Number of participants infected with non-M HIV-1 included compared to the total expected number of inclusions

    1 day

Secondary Outcomes (1)

  • Investigate the current molecular epidemiology of resistance in non-M HIV-1 variants in Cameroon

    1 Day

Other Outcomes (1)

  • Study the current molecular epidemiology of HIV 1 non-M variant resistance in Cameroon

    1 day

Study Arms (2)

Retrospective

Dried Blood Spot samples tested positive for HIV during the previous national epidemiologic surveys Demographic health surveys in Cameroon

Diagnostic Test: Prospective

Prospective

Individuals who came to Center Pasteur in Yaounde or Garoua for HIV screening or viral load monitoring

Diagnostic Test: Prospective

Interventions

ProspectiveDIAGNOSTIC_TEST

Blood samples will be collected in order to meet the objectives of this substudy and possibly for complementary research

ProspectiveRetrospective

Eligibility Criteria

Age21 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Retrospective phase : Dried Blood Spot samples tested positive for HIV during the Demographic health surveys in Cameroon 2011 and 2018 surveys, serotyping for HIV. Prospective phase : Individuals who came to Center Pasteur Cameroon in Yaoundé or Garoua for HIV screening or viral load monitoring, serotyping of HIV for positive samples.

You may qualify if:

  • All available samples tested positive for HIV during the national Health survey of Cameroon in 2011 And 2018
  • All Individuals who came to Centre Pasteur in Yaoundé or Garoua for HIV screening or viral load monitoring.

You may not qualify if:

  • Insufficient quantity or degraded Dried Blood Spot samples
  • All HIV-positive individuals aged less than 21 years, infected with a Group M HIV-1 virus, or those who refused to participate in the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood samples, 2x 5ml EDTA (ethylenediaminetetraacetic acid)

MeSH Terms

Conditions

HIV Infections

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System Diseases

Central Study Contacts

Mariam Gharib, PhD

CONTACT

Elodie Alessandri-Gradt, ParmD PhD

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
OTHER
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 31, 2025

First Posted

April 6, 2025

Study Start

June 30, 2025

Primary Completion (Estimated)

July 1, 2027

Study Completion (Estimated)

July 1, 2027

Last Updated

April 8, 2025

Record last verified: 2025-04

Data Sharing

IPD Sharing
Will not share