Drug Interaction Study of Famotidine and Atazanavir With Ritonavir in HIV-Infected Patients
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
1 other identifier
interventional
40
2 countries
4
Brief Summary
The purpose of this clinical research study is to assess the effect of Famotidine given twice daily on Atazanavir administered with Ritonavir in HIV-Infected subjects.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_4 hiv-infections
Started Dec 2006
Shorter than P25 for phase_4 hiv-infections
4 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 3, 2006
CompletedFirst Posted
Study publicly available on registry
October 6, 2006
CompletedStudy Start
First participant enrolled
December 1, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2007
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2007
CompletedFebruary 5, 2010
November 1, 2008
1 year
October 3, 2006
February 3, 2010
Conditions
Outcome Measures
Primary Outcomes (1)
Atazanavir plasma drug concentrations
on days 10, 11, 17, 18, 24 and 25
Secondary Outcomes (6)
Ritonavir plasma drug concentrations
on days 10, 11, 17, 18, 24 and 25
Safety measures: Physical examinations
ECGs
entry and discharge
laboratory tests including, liver and renal function
entry, discharge and days 11, 18
CD4 count
discharge
- +1 more secondary outcomes
Study Arms (6)
A1
NO INTERVENTIONA2
EXPERIMENTALA3
EXPERIMENTALB1
NO INTERVENTIONB2
EXPERIMENTALB3
EXPERIMENTALInterventions
Capsules/capsules, Oral, 300/100 mg, Once daily, 10 days.
Capsules/capsules + Tablets, Oral, 300/100 mg + 40 mg, Once daily + Twice daily, 7 days.
Capsules/capsules + Tablets + Tablets, Oral, 300/100 mg + 300 mg + 40 mg, Once daily + Twice daily, 7 days.
Eligibility Criteria
You may qualify if:
- HIV-infected male and female subjects between the ages of 18 to 65 years old with a BMI 18 to 35 kg/m²
- Prior to enrollment subjects must be currently receiving Atazanavir/Ritonavir plus at least 2 NRTIs, must have plasma HIV RNA \<400 copies/mL and have CD4 count \>200 cells/mm³
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (4)
Garden State Infectious Disease Associates, Pa
Voorhees Township, New Jersey, 08043, United States
Unc Center For Aids Research
Chapel Hill, North Carolina, 27599, United States
Local Institution
Philadelphia, Pennsylvania, 19104, United States
Local Institution
London, Greater London, SW10 9TH, United Kingdom
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Bristol-Myers Squibb
Bristol-Myers Squibb
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
October 3, 2006
First Posted
October 6, 2006
Study Start
December 1, 2006
Primary Completion
December 1, 2007
Study Completion
December 1, 2007
Last Updated
February 5, 2010
Record last verified: 2008-11