Antiretroviral therapy proviral genotype-guided: pilot-proof of concept clinical trial.

Fundación para la Investigación Biomédica del Hospital Universitario La Paz0 个研究点目标入组 40 人开始时间: 2017年6月12日最近更新: 2023年10月16日

试验速览

暂无简介。

•1. Patient infected with HIV-1.
•2. Age> 18 years.
•3. Receiving stable antiretroviral treatment for at least 3 months.
•4. Current or historical treatment with 3TC or FTC.
•5. Desire to change antiretroviral treatment due to intolerance or interest in simplification.
•6. Undetectable viral load (<50 copies/mL) for at least 1 year. A blip (=500 copies/mL) is allowed within three months prior to inclusion in the study, preceded and followed by undetectable determination.
•7. Current CD4 level> 350 cells/µL.
•8. Naïve to integrase inhibitors.
•9. Able to understand and give written informed consent.
•10. For those included in group 1 (20 patients): no history of virological failure with an ART regimen that included 3TC or FTC or at the time of failure had a population genotype without M184V/I or K65R/E/N.
•11. For those included in group 2 (20 patients): history of virological failure with TAR guideline including 3TC or FTC and historical genotype with mutations M184V/I or K65R /E/N.
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 40
•F.1.3 Elderly (>=65 years) no
•F.1.3.1 Number of subjects for this age range

•1. Detection of any of the following mutations in proviral DNA in peripheral blood by conventional sequencing: M184V/I or K65R/E/N.
•2. Pregnant, lactating or fertile women who do not commit to using an adequate contraceptive method.

发起方

Fundación para la Investigación Biomédica del Hospital Universitario La Paz