Randomized, double-blind, placebo-controlled clinical trial to evaluate the effect of Raltegravir intensification (1.200 mg QD) on the gut microbiota of chronically HIV-1 infected subject over time: THE RAGTIME STUDY

FUNDACIÓ LLUITA CONTRA LA SIDA0 个研究点开始时间: 2017年1月4日最近更新: 2017年4月3日

适应症

试验速览

暂无简介。

•1. Age =18 years old
•2. Documented HIV infection
•3. Stable antiretroviral treatment including PIi/r or NNRTIi-based 3 drugs ART for at least 6 months.
•4. Plasma HIV-1 RNA load <50 copies/mL for at least 12 months.
•5. Signed Informed 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 60
•F.1.3 Elderly (>=65 years) no
•F.1.3.1 Number of subjects for this age range

•1. PI/r monoterapy
•2. INSTI therapy during the previous 6 months
•3. Evidence of previous INSTI resistance
•4. Creatine clearance <50 mL/min
•5. Child- Pugh B or C
•6. History of active uncontrolled GI disorders or diseases including:
•6.1. Major surgery of the GI tract, with the exception of cholecystectomy and appendectomy, in the previous 5 years.
•6.2. Any major bowel resection at any time
•6.3. Any chronic digestive disease such as peptic ulcer, Crohn’s disease, ulcerative colitis, coeliac disease, confirmed intolerance to lactose or indeterminate colitis.
•6.4. Persistent infectious gastroenteritis, colitis or gastritis; persistent or chronic diarrhea of unknown etiology; Clostridium difficile infection (recurrent) or Helicobacter pylori infection (untreated);
•6.5. Irritable bowel syndrome (moderate-severe)
•6.6. Chronic constipation
•6.7. Active proctitis
•7. Antibiotic therapy within the previous 2 months
•8. In women, pregnancy or breastfeeding

发起方

FUNDACIÓ LLUITA CONTRA LA SIDA