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

University Hospital Center (CHU) Dijon Bourgogne

Status: Completed

Conditions: HIV-1-infection

Treatments: Biological: Blood samples

Study type: Observational

Funder types: Other

Identifiers

NCT03512795

BLOT AOI 2017

Details and patient eligibility

About

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.

Enrollment: 71 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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