A randomized, pilot clinical trial designed to compare, in human immunodeficiency virus infected patients who never have received antiretroviral therapy, the evolution of cerebral function and the neurocognitive efficient after 24 weeks of treatment with 2 regimens of highly efficacy antiretroviral treatment with different levels of central nervous system penetration. - Apache

Fundación para la Investigación Biomédica del Hospital Universitario La Paz0 个研究点开始时间: 2012年11月29日最近更新: 2013年2月18日

试验速览

暂无简介。

•- HIV-positive by ELISA and confirmed by WB
•- Age> 18 years
•- Never have received antiretroviral treatment for HIV
•- CV baseline of HIV> 100,000 copies / mL
•- No evidence of genotypic resistance against antiretroviral
•- Study HLA B5701 negative
•- Having a VL <100,000 copies / mL
•- Able to understand and give written informed consent.
•- Meet the criteria to initiate the AR treatment according to Gesida 2012 Guideline.
•-Women of childbearing potential should have a pregnancy test negative in blood or urine during the 7 days prior to initiation of therapy and postmenopausal women should have amenorrhea for at least 12 months to consider that they are of childbearing age.
•- Non pregnant or lactating without heterosexual activity during the entire study or heterosexual activity and willing to use two methosds of contraception. The two methods of contraception can be 2 barrier methods or a barrier method and a method to prevent pregnancy hormone, used during the entire study and for 12 weeks after completion.
•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. Pregnant or lactating women and women of childbearing age who are not committed to use adequate contraception method.
•2. Previous history of serious confounding neurological comorbidities defined as:
•- Dependence on drugs or alcohol
•- CNS opportunistic infections
•- Major depression or psychosis
•- Previous diagnosis of dementia
•- Mental retardation
•- CNS neurological disease
•- Co-infection with hepatitis C virus
•3. Claustrophobia
•4. Existence of magnetizable body devices
•5. Inability to perform and complete a full neurologic assessment
•6. Renal insufficiency (creatinine clearance <60 mL / min)
•7. Diabetes mellitus or cardiovascular risk> 10% calculated by Framingham
•8. The following analytical criteria:
•- Neutropenia <750 cells / ?L
•- Hemoglobin <8.0 g / dL
•- Platelets <50,000 cells / ?L
•- Levels of GOT, GPT and GGT greater than 5 times the baseline levels

发起方

Fundación para la Investigación Biomédica del Hospital Universitario La Paz