Clinical trial

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

Name
BLOT AOI 2017
Description
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.
Trial arms
Trial start
2018-08-08
Estimated PCD
2020-03-05
Trial end
2020-03-05
Status
Completed
Treatment
Blood samples
An additional blood tube will be taken during the patient's follow-up blood collection.
Size
71
Primary endpoint
> 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
Eligibility criteria
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
Protocol
{'studyType': 'OBSERVATIONAL', 'patientRegistry': False, 'designInfo': {'observationalModel': 'OTHER', 'timePerspective': 'PROSPECTIVE'}, 'enrollmentInfo': {'count': 71, 'type': 'ACTUAL'}}
Updated at
2024-02-23

1 organization