Phase 4 clinical trial, randomized to evaluate the effect on immune recovery of triple antiretroviral maintenance therapy (elvitegravir / cobicistat 150/150 mg + tenofovir + emtricitabine alapenamide 10 mg 200 mg) versus simplification of combination therapy (dolutegravir + lamivudine or darunavir / Cobicistat + lamivudine) in HIV-infected patients with sustained undetectable viremia.

Fundación Pública Andaluza para la Gestión en Salud de Sevilla (FISEVI)0 个研究点目标入组 180 人开始时间: 2017年1月25日最近更新: 2017年4月10日

适应症

试验速览

暂无简介。

•- Patients with HIV infection and age = 18 years.
•- Initiation of antiretroviral treatment after 01/01/2013
•- Undetectable viremia (<20 copies / ml for at least one year) with triple therapy.
•- Nadir and CD4 + T lymphocyte count =200 / µl at the time of inclusion.
•Informed written consent.
•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 160
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 20

•- Presence of major resistance mutations to any of the study drugs.
•- Opportunistic infections active at the time of inclusion.
•- Pregnancy at the time of inclusion or during the follow-up period.
•- Active co-infection with B or C virus of hepatitis.
•- Cirrhosis, portal hypertension and / or hypersplenism of any etiology.
•- Past or current neoplasms of steroid treatment, immunomodulators, or chemotherapy
•- Laboratory abnormalities grade 3 or 4.
•- Concomitant use of drugs with higher drug interactions with study drugs, according to respective product data sheets.
•- Estimated creatinine clearance <50ml / min.
•- Withdrawal of informed consent.
•- Patients who do not complete the follow-up period or with virological failure, defined as viremia> 200 copies in two consecutive determinations, during follow-up will be excluded from the analysis.

发起方

Fundación Pública Andaluza para la Gestión en Salud de Sevilla (FISEVI)