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).
- Conditions
- HIV infected SubjectsMedDRA version: 8.1Level: LLTClassification code 10020161Term: HIV infection
- Registration Number
- EUCTR2006-003163-31-GB
- Lead Sponsor
- Bristol-Myers Squibb International Corporation
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 36
* Signed written informed consent
* Either:
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
Or:
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
(m)]²
* 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
*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
disease
*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
ATV/RTV)
*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)
*Use of any prescription or nonprescription drugs within 4 weeks prior to Day 1 of on
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method