HIV A6 Genome In ART Unsuccessful Patients On DOR (HIV-A6-DOR)

April 4, 2022 updated by: Gamaleya Research Institute of Epidemiology and Microbiology, Health Ministry of the Russian Federation

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

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

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Anticipated)

60

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Adult (over 18 years of age) patients who have a confirmed diagnosis of HIV infection will be invited to participate in the study. Military personnel and pregnant women will not be included in the study unless such studies are necessary for these patients. Patients must have a virologic failure on their first ART regimen that includes NNRTIs.

Description

Inclusion Criteria:

  • HIV-infection confirmed
  • > 18 years
  • Informed consent signed

Exclusion Criteria:

  • Pregnant women

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
HIV patients
All patients will be prescribed treatment drugs in accordance with the national protocol by the doctors of the AIDS centers. The decision to prescribe Doravirine will also be made by doctors.
Drug: Doravirine
Doravirine will be given to patients after failure on the first NNRTI regimen.
Other Names:
  • DOR

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
HIV viral load
Time Frame: Week 8
The result of measuring the HIV viral load 8 weeks after the start of DOR-based treatment. The success of therapy will correspond to an undetectable level of viral load (less than 50 RNA copies/ml) or a decrease of two logarithms compared with the values before treatment start. Upon receipt of a detected viral load, treatment will be nevertheless continued up to 24 weeks.
Week 8
HIV viral load
Time Frame: Week 24
The result of measuring the HIV viral load 24 weeks after the start of DOR-based treatment. The success of therapy will correspond to an undetectable level of viral load (less than 50 RNA copies/ml). Upon receipt of any detected viral load, the treatment will be considered a failure and the reasons for the failure (lack of adherence, drug interactions, non-compliance with dietary requirements, etc.) will be analyzed. If these causes are excluded, the HIV genotype will be analyzed for the presence of drug resistance mutations (RT genome region).
Week 24

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
HIV genotype
Time Frame: Week 24
HIV genotype in patients experienced failure on DOR-based treatment regimen (RT genome region). The study of the genotype will make it possible to understand to which of the components of the therapy regimen the virus has developed resistance and which of the drugs needs to be replaced. If it turns out to be a drug from the basic regimen (not DOR but NRTIs), the regimen will be changed at the discretion of the attending physician (this decision is not within the scope of this project). If DOR resistance mutations are detected such as V106I or Y188L, their frequency will be estimated (the proportion of patients with such mutations ) and the spectrum of associated mutations will be analysed.
Week 24

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Gamaleya Research Institute of Epidemiology and Microbiology, Health Ministry of the Russian Federation

Collaborators

MSD Pharmaceuticals LLC

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

May 1, 2022

Primary Completion (Anticipated)

May 1, 2023

Study Completion (Anticipated)

January 1, 2024

Study Registration Dates

First Submitted

March 22, 2022

First Submitted That Met QC Criteria

April 4, 2022

First Posted (Actual)

April 11, 2022

Study Record Updates

Last Update Posted (Actual)

April 11, 2022

Last Update Submitted That Met QC Criteria

April 4, 2022

Last Verified

April 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MISP#60102

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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