EUCTR2006-003163-31-GB进行中（未招募）1 期
Open-Label, Multiple-Dose, Drug Interaction Study to Assess the Effect of Famotidine with or without Tenofovir on the Pharmacokinetics of Atazanavir when given with Ritonavir in HIV-Infected Subjects. Revised Protocol 02 incorporating amendment 03 (Version 1.0, Date 09-Mar-2007) and amendment 04 (Version 1.0, Date 02-Jul-2007). And Pharmacogenetics Blood Sample Amendment 01 - Site Specific (Version 5.0, Date 14-Sep-2006).
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 36
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •* Signed written informed consent
- •i) For Cohort 1, are receiving an ARV treatment regimen containing ATV/RTV 300/100 mg + at least 2 NRTIs (dosing per USPI or SmPC)(not TDF) continuously for at least 5 months prior to enrollment, or
- •ii) For Cohort 2, are receiving an ARV treatment regimen containing ATV/RTV 300/100 mg + at least 1 NRTI + TDF continuously for at least 5 months prior to enrollment
- •iii) Have had plasma HIV RNA < 400 copies/ml on at least 2 prior measurements
- •(6-20 weeks prior to enrollment and less than 3 wks prior to Day 1)
- •Also have Day -2 HIV RNA measurement of < 400 copies/ml with results
- •available prior to Day 11 dosing of FAM
- •i) For Cohort 1, are receiving an ARV treatment regimen containing ATV/RTV 300/100 mg + at least 2 NRTIs (dosing per USPI or SmPC) (not TDF) continuously for at least 3 months prior to enrollment, or
- •ii) For Cohort 2, are receiving an ARV treatment regimen containing ATV/RTV 300/100 mg + at least 1 NRTI + TDF continuously for at least 3 months prior to enrollment
- •iii) Have had plasma HIV RNA < 400 copies/ml on at least 2 prior measurements
- •(6-12 weeks prior to enrollment and less than 3 wks prior to Day 1). Also
- •have Day -2 HIV RNA measurement of < 400 copies/ml with results available
- •prior to Day 11 dosing of FAM
- •* Have CD4 Count > 200 cells/mm³
- •* Have no history of virologic failure on a protease inhibitor (PI) or documented
- •phenotypic PI resistance or primary PI mutations (according to IAS
- •recommendations).
- •* Have no documented phenotypic resistance to ATV or primary genotypic
- •mutations causing resistance to ATV.
- •* Body Mass Index (BMI) of 18 to 35 kg/m², inclusive. BMI = weight (kg)/[height
- •* Men and women, ages 18 to 65 inclusive
- •* WOCBP must use effective barrier contraception. Other methods of oral
- •contraception, in addition to barrier methods, are permitted (see Protocol Section 6.4.3; Precautions for details regarding potential interactions with ATV and some oral
- •contraceptives).
- •WOCBP must be using an adequate method of contraception to avoid pregnancy
- •throughout the study and for up to 8 weeks after the study in such a manner that
- •the risk of pregnancy is minimized.
- •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
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •*WOCBP unwilling or unable to use an acceptable method to avoid pregnancy for entire study period & for up to 8 weeks after study; acceptable method must include practice of barrier contraception
- •*WOCBP using oral contraceptives without a barrier method. Caution is warranted
- •with co-administration of oral contraceptives(ethinyl estradiol & norethindrone)
- •*Pregnant or breastfeeding women
- •*Women with positive pregnancy test on enrollment or prior to study drug administration
- •*Men unwilling or unable to agree to practice barrier contraception for duration of study & at least 3 months after dosing
- •*Any history of CD4 cell count < 50 cell/mm³
- •*History of virologic failure (2 consecutive plasma HIV RNA measurements >400
- •copies/mL) while being administered a PI
- •*Any significant acute illness within 6 months of Study Day 1 or chronic medical illness unless stable or controlled by non-prohibited medication
- •*History of gastroesophageal reflux disease, hiatal hernia, or peptic/gastric ulcer
- •*Any major surgery within 4 weeks of Day 1 of on-study ATV
- •*Any gastrointestinal surgery that could impact upon the absorption of study drug
- •(ATV/RTV +/- FAM)
- •*Donation of blood or plasma to a blood bank or in a clinical study (except a
- •screening visit) within 4 weeks of Day 1 of on-study ATV
- •*Blood transfusion within 4 weeks of Day 1 of on-study ATV
- •*Inability to tolerate oral medication
- •*Inability to tolerate venipuncture and/or venous access
- •*Subjects with history of Gilbert’s syndrome
- •*Intractable diarrhea (= 6 loose stools/day for at least 7 consecutive days) within
- •30 days prior to Day 1 of on-study ATV
- •*History of hemophilia
- •*History of chronic pancreatitis
- •*History of hypochlorhydria or achlorhydria
- •*Recent (=6 months prior to enrollment) drug or alcohol abuse as defined in
- •DSM IV, Diagnostic Criteria for Drug & Alcohol Abuse
- •*Any other sound medical, psychiatric &/or social reason as determined by
- •Investigator
- •*Evidence of organ dysfunction or any clinically significant deviation in physical
- •examination, vital signs, ECG or clinical laboratory determinations, not expected for the extent of HIV disease
- •*Positive urine screen for drugs of abuse at screening or Day -2 without valid
- •prescription (except for cannabinoids)
- •*Creatinine clearance, estimated by method of Cockcroft & Gault <60 mL/min
- •*Liver enzymes (AST, ALT) >3X upper limit of normal
- •*Total bilirubin > 10X upper limit of normal (due to ARV regimen containing
- •*2nd- or 3rd-degree A-V block or clinically relevant ECG abnormalities
- •*Positive pregnancy test for females only(minimum sensitivity of 25 IU/L
- •equivalent units of HCG)
- •*Previously documented phenotypic PI resistance or Primary PI mutations
- •*Previously documented phenotypic or genotypic resistance to currently
- •prescribed nucleoside/nucleotide reverse transcriptase inhibitors such that subjects
- •are being treated with < 3 active antiretrovirals
- •*History of allergy to HIV protease inhibitors (ATV, RTV), HIV nucleoside or
- •nucleotide reverse transcriptase inhibitors or H2-receptor antagonists which the
- •patient will be administered during the study
- •*History of significant drug allergy or adverse drug reaction related to any study
- •drug (ATV/RTV +/- FAM) class in the study
- •*Prior exposure to any investigational drug or placebo within 4 weeks of Day 1 of
- •on-study ATV, except protocol-required pre-study minimum 5 month regimen (ATV/RTV, = 2NRTIs)
- 另有 1 项未显示
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