Characterization of HIV-1 Reservoirs in HIV-1 Non-B Infected Adolescents on ART in Cameroon

NCT06363500 | Completed

• 1 other identifier: ChantalIRCB
• Study Type: observational
• Target: 140
• Locations: 1 country
• Sites: 1

Brief Summary

Background: Combination antiretroviral therapy (cART) can bring HIV-1 in blood plasma to level undetectable by standard tests and allow a near-normal life expectancy for HIV-infected individuals. Unfortunately, cART is not curative, as within a few weeks of treatment cessation, HIV viremia in most patients rebounds except for rare elite or post-treatment controllers of viremia. The primary source of this rebound is the highly stable reservoir of latent yet replication-competent HIV-1 proviruses integrated into the genomic DNA of resting memory CD4+ T cells. To achieve a cure for HIV, understanding the cell reservoir environment is of paramount importance. The size and nature of viral reservoir might vary per timing of therapy, therapeutic response, ART duration, and immune response. Mechanisms of reservoir maintenance generally depend on levels/type of immune recognition, dynamics of viral persistence are different between pediatric and adult populations, owing to, but not limited to, types/numbers of target cells, efficiency in clearing HIV-infected cells, plasma viremia and HIV drug resistance patterns. This difference could become more evident as these children grow toward adolescence (increasing population due to ART benefits), a stage during which suboptimal adherence is frequent, leading to viral rebound and archiving of resistant patterns. Objectives: We plan to conduct a cross sectional study with the aim to characterize HIV reservoirs and their variability according to virological and immunological profiles of non-B HIV-1 vertically infected adolescents receiving antiretroviral therapy. Specifically, we shall (1) evaluate the size of HIV reservoir; (2) Determine HIV-1 genetic variability and drug resistance in cellular reservoirs; (3) Characterize immune activation/inflammation of HIV infected adolescents. Methods: We plan to conduct an observational and comparative study involving 90 HIV-1 non-B infected adolescents aged 10-19 years vertically infected, have been on ART for at least 12 months selected from a cohort of the ongoing EDCTP-READY study; intravenous blood will be collected for CD4/CD8 count, plasmatic viral load, PBMCs isolation, immune activation/inflammatory markers, genotyping and Viral reservoir quantification. We will as well recruit a group of 30 HIV-negative adolescents as control for immunological profiling. Overall impact: Our findings will help in advancing knowledge on HIV reservoir, in terms of size and genetic variability in adolescents living with HIV (ADLHIV). Such evidence will also help in understanding the effects of ART timing and duration on the size of reservoirs among ADLHIV, a unique population from whom findings generated will largely contribute in designing functional cure strategies in this vulnerable population.

Conditions

Characterization of HIV Reservoirs in Adolescents

Outcome Measures

Primary Outcomes (1)

• Archived HIV drug resistance mutations

  Identify HIV drug resistance mutations in pro-viral HIV DNA

  6 months

Secondary Outcomes (1)

• HIV-1 reservoirs measurement

  1 year

Interventions

non applicable OTHER

Only blood sample collection

Eligibility Criteria

• Age: 10 Years - 19 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

HIV+ adolescents on antiretroviral treatment

You may qualify if:

• Consenting HIV+ Adolescents on ART

You may not qualify if:

• Insufficient blood for lab tests

Sponsors & Collaborators

• Chantal Biya International Reference Centre for Research on Prevention and Management of HIV/AIDS: lead

Study Sites (1)

Chantal Biya International Reference Centre

Yaoundé, Centre Region, 99999, Cameroon

Location

Biospecimen

Retention: SAMPLES WITH DNA

DNA samples extracted from PBMCs

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Researcher

Study Record Dates

• First Submitted: April 9, 2024
• First Posted: April 12, 2024
• Study Start: November 1, 2021
• Primary Completion: October 30, 2023
• Study Completion: November 30, 2023
• Last Updated: April 12, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)