HIV-1-infection Clinical Trial
— V106IFCOfficial title:
Phenotypic and Site Directed Mutagenesis Analysis on the Impact of V106I in HIV-1 Reverse Transcriptase on Resistance to Doravirine
Objective. To study the impact of V106I mutation in the reverse transcriptase of HIV-1 on the activity of Doravirine. Clinical hypotheses. Doravirine shows a unique resistance pattern with a higher genetic barrier to resistance than other NNRTIs. In contrast to K103N or E138A, the prevalence of single mutations and/or combination of mutations against Doravirine is low. However, in a recent survey conducted in Spain the study investigators have found a V106Iprevalence similar to K103N and E138A. There is a clear need to understand the real impact of this mutation on Doravirine resistance.
Status | Not yet recruiting |
Enrollment | 50 |
Est. completion date | May 1, 2022 |
Est. primary completion date | October 1, 2021 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 13 Years to 75 Years |
Eligibility | Inclusion Criteria: Antiretroviral-naïve subjects over 13 years of age, including both seroprevalent and seroconverter patients Exclusion Criteria: Patients with prior antiretroviral exposure - |
Country | Name | City | State |
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n/a |
Lead Sponsor | Collaborator |
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Fundación Pública Andaluza para la Investigación Biomédica Andalucía Oriental |
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Soulie C, Santoro MM, Charpentier C, Storto A, Paraskevis D, Di Carlo D, Gennari W, Sterrantino G, Zazzi M, Perno CF, Calvez V, Descamps D, Ceccherini-Silberstein F, Marcelin AG. Rare occurrence of doravirine resistance-associated mutations in HIV-1-infected treatment-naive patients. J Antimicrob Chemother. 2019 Mar 1;74(3):614-617. doi: 10.1093/jac/dky464. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Fold Change in resistance to Doravirine | Change in EC50 for resistance to Doravirine in the presence of V106I | Day 0 |
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