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).

Overview

No summary available.

Registry

who.int

Start Date

October 31, 2006

End Date

December 15, 2007

Last Updated

5 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Sponsor

•\* 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

•\*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