NCT05322083

Brief 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

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started May 2022

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 22, 2022

Completed
20 days until next milestone

First Posted

Study publicly available on registry

April 11, 2022

Completed
20 days until next milestone

Study Start

First participant enrolled

May 1, 2022

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2023

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2024

Completed
Last Updated

April 11, 2022

Status Verified

April 1, 2022

Enrollment Period

1 year

First QC Date

March 22, 2022

Last Update Submit

April 4, 2022

Conditions

Virus-HIV

Keywords

HIV, mutation, resistance

Outcome Measures

Primary Outcomes (2)

  • 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.

    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).

    Week 24

Secondary Outcomes (1)

  • HIV genotype

    Week 24

Study Arms (1)

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

Interventions

DoravirineDRUG

Doravirine will be given to patients after failure on the first NNRTI regimen.

Also known as: DOR
HIV patients

Eligibility Criteria

Age18 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

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

You may not qualify if:

  • Pregnant women

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (4)

  • 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.

    PMID: 32005262BACKGROUND

  • 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.

    PMID: 28814231BACKGROUND

  • 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.

    PMID: 22903393RESULT

  • 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.

    PMID: 27751765RESULT

Related Links

Biospecimen

Retention: SAMPLES WITH DNA

Blood plasma and whole blood

MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome

Interventions

doravirine

Condition Hierarchy (Ancestors)

HIV InfectionsBlood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesSlow Virus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System Diseases

Central Study Contacts

Marina Bobkova, DrSci

CONTACT

+79163138387mrbobkova@mail.ru

Anna Kuznetsova, PhD

CONTACT

‭+79037820779‬a-myznikova@list.ru

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 22, 2022

First Posted

April 11, 2022

Study Start

May 1, 2022

Primary Completion

May 1, 2023

Study Completion

January 1, 2024

Last Updated

April 11, 2022

Record last verified: 2022-04