Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
60 participants
OBSERVATIONAL
2022-05-31
2024-01-31
Brief Summary
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Detailed Description
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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
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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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.
Doravirine
Doravirine will be given to patients after failure on the first NNRTI regimen.
Interventions
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Doravirine
Doravirine will be given to patients after failure on the first NNRTI regimen.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* \> 18 years
* Informed consent signed
Exclusion Criteria
18 Years
ALL
No
Sponsors
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MSD Pharmaceuticals LLC
INDUSTRY
Gamaleya Research Institute of Epidemiology and Microbiology, Health Ministry of the Russian Federation
OTHER
Responsible Party
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Central Contacts
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References
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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.
Lapovok 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.
Baryshev 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.
Venner 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.
Related Links
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Clinical Guidelines on treatment HIV-infection in Russia, 2017
Other Identifiers
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MISP#60102
Identifier Type: -
Identifier Source: org_study_id
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