A phase IV, multicenter, open and randomized study to evaluate the impact of the change of antiretroviral treatment from dual therapy to triple therapy on inflammation in patients with type 1 HIV infection. - INSTINCT

Fundación SEIMC-GESIDA0 个研究点目标入组 234 人开始时间: 2019年6月11日最近更新: 2019年12月10日

试验速览

暂无简介。

•- Men and women = 18 years
•- Confirmed and documented diagnosis of HIV-1 infection
•- Virological suppression of more than 48 weeks (confirmed with HIV RNA <50 copies / ml). The determination of the QoL of a routine routine analysis of = 12 weeks prior to the signing of the consent is allowed.
•- ART in stable dual therapy (> 48 weeks) with DTG + 3TC
•- Signed informed consent
•- Negative pregnancy test (only women of childbearing age). A woman of childbearing age is considered to be a woman who has not undergone permanent infertility procedures or who has been amenorrheic for less than 12 months.
•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 234
•F.1.3 Elderly (>=65 years) no
•F.1.3.1 Number of subjects for this age range

•- Impossibility of obtaining written informed consent to participate in the study
•- Pregnant or lactating women or those who intend to become pregnant during the study period and do not commit to using proven contraceptive methods
•- Any suspicion or confirmation of resistance to TAF, FTC, DTG or BIC.
•- Patients with known hypersensitivity to any excipient used with TAF, 3TC, FTC, DTG or BIC
•- Any autoimmune or chronic inflammatory disease
•- Use of immunomodulatory or immunosuppressive agents, including steroids
•- Chronic treatment with aspirin, statins and other anti-inflammatory agents
•- Any acute infection in the last 2 months
•- Estimated glomerular filtration rate (eGFR) <30 mg / ml / m2 measured by any of the available formulas. The determination of the eGFR of a routine preliminary analysis of = 12 weeks prior to the signing of the consent is allowed
•- Contraindication for the use of TAF
•- Clinical status of the patient in rapid deterioration or the researcher considers that there is no reasonable hope that the patient will complete the study
•- Simultaneous participation in another clinical trial or research study that requires the need for treatment with other drugs outside the study or interfere with the visits of the same.
•- Any situation that, in the investigator opinion, could interfere with the patient's ability to comply with the treatment guideline and the protocol evaluations

发起方

Fundación SEIMC-GESIDA