Virus-HIVHIV-A6-DORNCT05322083
HIV A6 Genome In ART Unsuccessful Patients On DOR
An observational study of Virus-HIV, run by Gamaleya Research Institute of Epidemiology and Microbiology, Health Ministry of the Russian Federation.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Virus-HIV
- What is being tested?
- Doravirine
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- May 2022to Jan 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
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.
Who may be able to join
- HIV-infection confirmed
- > 18 years
- Informed consent signed
Who cannot join
- Pregnant women
Trial locations and contacts
No sites are listed yet.
About this study
Official title: 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
Read the 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
- Being tested
- Doravirine
- Keywords
- HIV, mutation, resistance
- Medical subject headings
- Acquired Immunodeficiency Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DoravirineDrug
Also called DOR
Doravirine will be given to patients after failure on the first NNRTI regimen.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Doravirine |
What is being measured
The primary outcome is the main question the study is designed to answer.
HIV viral load
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.
Measured: Week 8
HIV viral load
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).
Measured: Week 24
Secondary outcomes (1)
HIV genotype
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.
Measured: Week 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2022
- Study startMay 2022 (estimated)
- Primary completionMay 2023 (estimated)
- Study completionJan 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Virus-HIVStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Gamaleya Research Institute of Epidemiology and Microbiology, Health Ministry of the Russian Federation
- Sponsor type
- University, hospital or other
- Collaborators
- MSD Pharmaceuticals LLC
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05322083
- Sponsor's protocol ID
- MISP#60102
- Acronym
- HIV-A6-DOR
- Status last verified
- Apr 2022
- First submitted
- 22 Mar 2022
- Last updated
- 11 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
Ayitewala A, Kyeyune F, Ainembabazi P, Nabulime E, Kato CD, Nankya I. Comparison of HIV drug resistance profiles across HIV-1 subtypes A and D for patients receiving a tenofovir-based and zidovudine-based first line regimens in Uganda. AIDS Res Ther. 2020 Jan 31;17(1):2. doi: 10.1186/s12981-020-0258-7.
PubMed 32005262Lapovok I, Laga V, Kazennova E, Bobkova M. HIV Type 1 Integrase Natural Polymorphisms in Viral Variants Circulating in FSU Countries. Curr HIV Res. 2017 Nov 23;15(5):318-326. doi: 10.2174/1570162X15666170815162052.
PubMed 28814231Baryshev PB, Bogachev VV, Gashnikova NM. Genetic characterization of an isolate of HIV type 1 AG recombinant form circulating in Siberia, Russia. Arch Virol. 2012 Dec;157(12):2335-41. doi: 10.1007/s00705-012-1442-4. Epub 2012 Aug 19.
PubMed 22903393Venner CM, Nankya I, Kyeyune F, Demers K, Kwok C, Chen PL, Rwambuya S, Munjoma M, Chipato T, Byamugisha J, Van Der Pol B, Mugyenyi P, Salata RA, Morrison CS, Arts EJ. Infecting HIV-1 Subtype Predicts Disease Progression in Women of Sub-Saharan Africa. EBioMedicine. 2016 Nov;13:305-314. doi: 10.1016/j.ebiom.2016.10.014. Epub 2016 Oct 12.
PubMed 27751765
Study at a glance
From the registry record, last updated by the sponsor on 11 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analysis of HIV Subtype A6 Genome in Patients With Virological Failure After Switching to Doravirine (DOR)
- ClinicalTrials.gov ID
- NCT05322083
- Acronym / sponsor ID
- HIV-A6-DOR / MISP#60102
- Conditions
- Virus-HIV
- Keywords
- HIV, mutation, resistance
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Gamaleya Research Institute of Epidemiology and Microbiology, Health Ministry of the Russian FederationUniversity, hospital or other
- Collaborators
- MSD Pharmaceuticals LLC
- Study start
- May 2022 (estimated)
- Primary completion
- May 2023 (estimated)
- Study completion
- Jan 2024 (estimated)
- First posted
- 11 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| HIV patients | – | Drug: DoravirineAll 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- HIV-infection confirmed
- > 18 years
- Informed consent signed
Key exclusion criteria (1 listed)
- Pregnant women
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DoravirineAlso: DORDoravirine will be given to patients after failure on the first NNRTI regimen. | Drug | HIV patients |
Primary outcome
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.
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).
1 secondary outcome
HIV genotype
Time frame: Week 24
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Apr 2022.
- Background: PubMed 32005262Ayitewala A, Kyeyune F, Ainembabazi P, Nabulime E, Kato CD, Nankya I. Comparison of HIV drug resistance profiles across HIV-1 subtypes A and D for patients receiving a tenofovir-based and zidovudine-based first line regimens in Uganda. AIDS Res Ther. 2020 Jan 31;17(1):2. doi: 10.1186/s12981-020-0258-7.
- Background: PubMed 28814231Lapovok I, Laga V, Kazennova E, Bobkova M. HIV Type 1 Integrase Natural Polymorphisms in Viral Variants Circulating in FSU Countries. Curr HIV Res. 2017 Nov 23;15(5):318-326. doi: 10.2174/1570162X15666170815162052.
- Results publication: PubMed 22903393Baryshev PB, Bogachev VV, Gashnikova NM. Genetic characterization of an isolate of HIV type 1 AG recombinant form circulating in Siberia, Russia. Arch Virol. 2012 Dec;157(12):2335-41. doi: 10.1007/s00705-012-1442-4. Epub 2012 Aug 19.
- Results publication: PubMed 27751765Venner CM, Nankya I, Kyeyune F, Demers K, Kwok C, Chen PL, Rwambuya S, Munjoma M, Chipato T, Byamugisha J, Van Der Pol B, Mugyenyi P, Salata RA, Morrison CS, Arts EJ. Infecting HIV-1 Subtype Predicts Disease Progression in Women of Sub-Saharan Africa. EBioMedicine. 2016 Nov;13:305-314. doi: 10.1016/j.ebiom.2016.10.014. Epub 2016 Oct 12.
- Clinical Guidelines on treatment HIV-infection in Russia, 2017Link provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
An observational study of Virus-HIV, run by Gamaleya Research Institute of Epidemiology and Microbiology, Health Ministry of the Russian Federation.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 11 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Marina Bobkova, DrSci (+79163138387, mrbobkova@mail.ru), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
HIV viral load (time frame: Week 8). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05322083, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Apr 2022.