Drug Interaction Study of Famotidine and Atazanavir With Ritonavir in HIV-Infected Patients

This study has been completed.
Sponsor:
Information provided by:
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT00384904
First received: October 3, 2006
Last updated: February 3, 2010
Last verified: November 2008

October 3, 2006
February 3, 2010
December 2006
December 2007   (final data collection date for primary outcome measure)
Atazanavir plasma drug concentrations [ Time Frame: on days 10, 11, 17, 18, 24 and 25 ]
Atazanavir plasma drug concentrations on days 10, 11, 17, 18, 24 and 25
Complete list of historical versions of study NCT00384904 on ClinicalTrials.gov Archive Site
  • Ritonavir plasma drug concentrations [ Time Frame: on days 10, 11, 17, 18, 24 and 25 ]
  • Safety measures: Physical examinations
  • ECGs [ Time Frame: entry and discharge ]
  • laboratory tests including, liver and renal function [ Time Frame: entry, discharge and days 11, 18 ]
  • CD4 count [ Time Frame: discharge ]
  • HIV viral load [ Time Frame: entry and discharge ]
  • 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)and HIV viral load (entry and discharge)
Not Provided
Not Provided
 
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

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.

Not Provided
Interventional
Phase 4
Allocation: Non-Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Parallel Assignment
Masking: Open Label
HIV Infections
  • Drug: Atazanavir/Ritonavir
    Capsules/capsules, Oral, 300/100 mg, Once daily, 10 days.
    Other Name: Reyataz
  • Drug: Atazanavir/Ritonavir + Famotidine
    Capsules/capsules + Tablets, Oral, 300/100 mg + 40 mg, Once daily + Twice daily, 7 days.
    Other Name: Reyataz
  • Drug: Atazanavir/Ritonavir + Famotidine
    Capsules/capsules + Tablets, Oral, 300/100 mg + 20 mg, Once daily + Twice daily, 7 days.
    Other Name: Reyataz
  • Drug: Atazanavir/Ritonavir
    Capsules/capsules + Tablets, Oral, 300/100 mg, Once daily, 10 days.
    Other Name: Reyataz
  • Drug: Atazanavir/Ritonavir + Tenofovir Disproxil Fumrarate + Famotidine
    Capsules/capsules + Tablets + Tablets, Oral, 300/100 mg + 300 mg + 40 mg, Once daily + Twice daily, 7 days.
    Other Name: Reyataz
  • Drug: Atazanavir/Ritonavir + Tenofovir Disproxil Fumrarate + Famotidine
    Capsules/capsules + Tablets + Tablets, Oral, 300/100 mg + 300 mg + 20 mg, Once daily + Twice daily, 7 days.
    Other Name: Reyataz
  • No Intervention: A1
    Intervention: Drug: Atazanavir/Ritonavir
  • Experimental: A2
    Intervention: Drug: Atazanavir/Ritonavir + Famotidine
  • Experimental: A3
    Intervention: Drug: Atazanavir/Ritonavir + Famotidine
  • No Intervention: B1
    Intervention: Drug: Atazanavir/Ritonavir
  • Experimental: B2
    Intervention: Drug: Atazanavir/Ritonavir + Tenofovir Disproxil Fumrarate + Famotidine
  • Experimental: B3
    Intervention: Drug: Atazanavir/Ritonavir + Tenofovir Disproxil Fumrarate + Famotidine
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
40
December 2007
December 2007   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • 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
Both
18 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
United States,   United Kingdom
 
NCT00384904
AI424-328
No
Study Director, Bristol-Myers Squibb
Bristol-Myers Squibb
Not Provided
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
Bristol-Myers Squibb
November 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP