NCT05322083

HIV A6 Genome In ART Unsuccessful Patients On DOR

Analysis of HIV Subtype A6 Genome in Patients With Virological Failure After Switching to Doravirine (DOR)

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 60 (estimated)
• Sponsor: Gamaleya Research Institute of Epidemiology and Microbiology, Health Ministry of the Russian Federation · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: —

Summary

The aim of the study is to evaluate the efficacy of Doravirine (DOR) in the second-line therapy for patients infected with HIV-1 sub-subtype A6 and its derivatives and having the mutations to previously used drugs

Detailed description

During the study 60-80 HIV-infected patients in 2-4 investigation sites (AIDS Centers) across Russia with proven virological failure on first-line antiretroviral therapy (ART) including efavirenz (EFV) and nevirapine (NVP) will be enrolled. The blood samples, epidemiological, clinical and demographic data of patients participating in the study must be collected. All participants must provide written informed consent before the start of the study. Virological failure on NNRTI regimen in all the participants will be confirmed by HIV genotyping. All the patients with confirmed NNRTI mutations will be switched to DOR instead of EFV/NVP in the second-line therapy and enrolled to the study. The primary efficacy endpoints of ART with DOR will be weeks 8 and 24 (viral load + T-cell count). For all samples with virological failure at weeks 8 or 24 HIV-1 DNA sequences (full protease (PR) and partial reverse transcriptase (RT) regions) will be obtained using the in-house test system or commercial kit (Central Research Institute of Epidemiology, Moscow, Russia). In case of virological failure of DOR treatment, the analysis of drug resistance mutations will be carried out.

Conditions

• Virus-HIV

Interventions

Type	Name	Description
DRUG	Doravirine	Doravirine will be given to patients after failure on the first NNRTI regimen.

Timeline

• Start date: 2022-05-01
• Primary completion: 2023-05-01
• Completion: 2024-01-01
• First posted: 2022-04-11
• Last updated: 2022-04-11

Regulatory

• FDA-regulated drug study