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Completed

NCT Number: NCT00384904

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

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.

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Key information

Conditions

HIV Infections Blood-Borne Infections Communicable Diseases Genital Diseases Immune System Diseases Immunologic Deficiency Syndromes Infections Lentivirus Infections RNA Virus Infections Retroviridae Infections Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Urogenital Diseases Virus Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Local Institution, London, Greater London, United Kingdom

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

atazanavir/ritonavir

Drug

Capsules/capsules, Oral, 300/100 mg, Once daily, 10 days.

Other names: Reyataz

Atazanavir/Ritonavir + Famotidine

Drug

Capsules/capsules + Tablets, Oral, 300/100 mg + 40 mg, Once daily + Twice daily, 7 days.

Other names: Reyataz

Atazanavir/Ritonavir + Tenofovir Disproxil Fumrarate + Famotidine

Drug

Capsules/capsules + Tablets + Tablets, Oral, 300/100 mg + 300 mg + 40 mg, Once daily + Twice daily, 7 days.

Other names: Reyataz

Primary outcomes

  1. Atazanavir plasma drug concentrations

    Time frame: on days 10, 11, 17, 18, 24 and 25

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Bristol-Myers Squibb

Industry

Registry information

Official study 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

Important dates

Study start
2006
Primary completion
2007
Study completion
2007
First posted
Oct 6, 2006
Registry last updated
Feb 5, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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