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

HIV-1-infection Clinical Trial

— Mutapro  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03512795
• Other study ID #: BLOT AOI 2017
• Status: Completed
• Start date: August 8, 2018
• Est. completion date: March 5, 2020

Study information

• Verified date: February 2024
• Source: Centre Hospitalier Universitaire Dijon
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 71
• Est. completion date: March 5, 2020
• Est. primary completion date: March 5, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• HIV-1-infection

Intervention

Biological:
• Blood samples
An additional blood tube will be taken during the patient's follow-up blood collection.

Locations

Country	Name	City	State
France	Chu Dijon Bourogne	Dijon

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire Dijon

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	> 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