Optimization of HIV-1 DNA Genotyping by High Throughput Sequencing to Document Antiretroviral Resistant Mutations

Completed

• Conditions: HIV-1-infection

• Registration Number: NCT03512795
• Lead Sponsor: Centre Hospitalier Universitaire Dijon

Brief Summary

The analysis of HIV resistance to antiretrovirals (Sanger sequencing on RNA) is difficult when the viral load is undetectable or during therapeutic breaks. In these situations, the ultra-deep sequencing (UDS) can be done on proviral DNA in order to improve characterization of archived resistant variants with may reflect past virological failures.

This study is a cross-sectional study which will require only one additional tube which can be taken during a routine check-up as part of the usual follow-up of the individuals included.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-04-19
• Study First Submitted QC: 2018-04-19
• Study First Posted: 2018-05-01
• Study Start: 2018-08-08
• Primary Completion: 2020-03-05
• Study Completion: 2020-03-05
• Status Verified: 2024-02
• Last Update Submitted: 2024-02-22
• Last Update Posted: 2024-02-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 71

Inclusion Criteria

• Patient who has given consent

• Adult patient

• Patient living with HIV-1

• Controlled viral load (<50 RNA copies/ml) for at least 1 year.

• At least two previous virologic failures, either :

  • Initial failure : defined as the persistence of a viral load greater than 50 copies/ml beyond 1 year, after the initiation of triple antiretroviral therapy, and without virological control (VL > 50 copies/ml) since the initiation of the very first antiretroviral treatment.
  • A rebound in HIV viral load to more than 50 copies/ml after a period of virological success, confirmed on two consecutive samples at least one month apart.

• At least 2 Sanger RNA genotypes have been done or could be done from the existing library.

Exclusion Criteria

• Patient not affiliated to a medical insurance scheme
• Protected adult
• Pregnant, parturient or breastfeeding woman
• Discontinuation of clinical and immuno-virological follow-up for more than 2 years

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
> Genotyping Score (GSS) comparison between HIV DNA-UDS genotyping assay obtained at inclusion and cumulative RNA-Sanger genotyping assays obtained at each virological failure during routine follow	baseline

Trial Locations

Locations (1)

Chu Dijon Bourogne; 🇫🇷 Dijon, France