Atazanavir and Famotidine Drug Interaction Study in HIV Subjects

• Research type

  Research Study

• Full title

  Open-Label, Multiple Dose, Drug Interaction Study to Assess the Effect of Famotidine on the Pharmacokinetics of Atazanavir in HIV-Infected Subjects Receiving Atazanavir with Ritonavir and Tenofovir

• IRAS ID

  65271

• Contact name

  Marta Boffito

• Sponsor organisation

  Bristol−Myers Squibb International Corporation

• Eudract number

  2009-016981-95

• ISRCTN Number

  Not Applicable

• Research summary

  This study is being conducted as many patients with Human Immunodeficiency Virus (HIV) require a combination of different drugs to treat the HIV infection. Also, many HIV patients are required to take additional drugs to treat illnesses other than the HIV infection. Before using different combinations of drugs, it is important to conduct studies to see if the drugs will affect the activity of one another.The purpose of this study is to assess the pharmacokinetics (how a drug is absorbed, distributed and eliminated from the body) of atazanavir with ritonavir and tenofovir (all known as antiretrovirals) when they are given with multi dose famotidine in HIV infected subjects. Famotidine is a drug which reduces the amount of acid that's produced by the stomach.In previous studies atazanavir/ritonavir and famotidine either with or without tenofovir has been given together in healthy subjects and also in HIV-infected patients. The combination of the drugs has been generally safe and well tolerated. In studies conducted in subjects not taking tenofovir, it has been shown that while famotidine reduced atazanavir concentrations, increasing atazanavir doses from 300 mg once daily to 400 mg once daily effectively lessened the decrease in atazanavir concentrations. Tenofovir is known to decrease atazanavir concentrations; however, large clinical trials have demonstrated the efficacy and safety of the tenofovir and atazanavir combination. The current study is designed to confirm that in patients taking tenofovir, increasing atazanavir doses to 400 mg once daily can effectively lessen the effects of famotidine decreasing the atazanavir concentration. This will ensure that the HIV will continue to be suppressed during the co-administration.

• REC name

  London - Riverside Research Ethics Committee

• REC reference

  10/H0706/87

• Date of REC Opinion

  14 Jan 2011

• REC opinion

  Further Information Favourable Opinion