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

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ClinicalTrials.gov Identifier: NCT00384904
Recruitment Status : Completed
First Posted : October 6, 2006
Last Update Posted : February 5, 2010
Sponsor:
Information provided by:
Bristol-Myers Squibb

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.

Condition or disease Intervention/treatment Phase
HIV Infections Drug: Atazanavir/Ritonavir Drug: Atazanavir/Ritonavir + Famotidine Drug: Atazanavir/Ritonavir + Tenofovir Disproxil Fumrarate + Famotidine Phase 4

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Official Title: 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
Study Start Date : December 2006
Actual Primary Completion Date : December 2007
Actual Study Completion Date : December 2007

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
No Intervention: A1 Drug: Atazanavir/Ritonavir
Capsules/capsules, Oral, 300/100 mg, Once daily, 10 days.
Other Name: Reyataz
Experimental: A2 Drug: Atazanavir/Ritonavir + Famotidine
Capsules/capsules + Tablets, Oral, 300/100 mg + 40 mg, Once daily + Twice daily, 7 days.
Other Name: Reyataz
Experimental: A3 Drug: Atazanavir/Ritonavir + Famotidine
Capsules/capsules + Tablets, Oral, 300/100 mg + 20 mg, Once daily + Twice daily, 7 days.
Other Name: Reyataz
No Intervention: B1 Drug: Atazanavir/Ritonavir
Capsules/capsules + Tablets, Oral, 300/100 mg, Once daily, 10 days.
Other Name: Reyataz
Experimental: B2 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
Experimental: B3 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



Primary Outcome Measures :
  1. Atazanavir plasma drug concentrations [ Time Frame: on days 10, 11, 17, 18, 24 and 25 ]

Secondary Outcome Measures :
  1. Ritonavir plasma drug concentrations [ Time Frame: on days 10, 11, 17, 18, 24 and 25 ]
  2. Safety measures: Physical examinations
  3. ECGs [ Time Frame: entry and discharge ]
  4. laboratory tests including, liver and renal function [ Time Frame: entry, discharge and days 11, 18 ]
  5. CD4 count [ Time Frame: discharge ]
  6. HIV viral load [ Time Frame: entry and discharge ]


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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00384904


Locations
United States, New Jersey
Garden State Infectious Disease Associates, Pa
Voorhees, New Jersey, United States, 08043
United States, North Carolina
Unc Center For Aids Research
Chapel-Hill, North Carolina, United States, 27599
United States, Pennsylvania
Local Institution
Philadelphia, Pennsylvania, United States, 19104
United Kingdom
Local Institution
London, Greater London, United Kingdom, SW10 9TH
Sponsors and Collaborators
Bristol-Myers Squibb
Investigators
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb

Additional Information:
Responsible Party: Study Director, Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT00384904     History of Changes
Other Study ID Numbers: AI424-328
First Posted: October 6, 2006    Key Record Dates
Last Update Posted: February 5, 2010
Last Verified: November 2008

Additional relevant MeSH terms:
HIV Infections
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Ritonavir
Atazanavir Sulfate
Tenofovir
Famotidine
HIV Protease Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-HIV Agents
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
Cytochrome P-450 CYP3A Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Reverse Transcriptase Inhibitors
Nucleic Acid Synthesis Inhibitors
Anti-Ulcer Agents
Gastrointestinal Agents
Histamine H2 Antagonists
Histamine Antagonists
Histamine Agents