Drug Interaction Study With Famotidine, Atazanavir, and Atazanavir/Ritonavir/Tenofovir
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ClinicalTrials.gov Identifier: NCT00365339 |
Recruitment Status
:
Completed
First Posted
: August 17, 2006
Last Update Posted
: April 8, 2011
|
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
HIV Infections | Drug: Atazanavir+Ritonavir+Tenofovir Drug: Atazanavir+Ritonavir+Tenofovir+Famotidine | Phase 1 |
Study Type : | Interventional (Clinical Trial) |
Enrollment : | 40 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Official Title: | Randomized, Open-Label, Multiple-Dose Study to Evaluate the Effect of Famotidine on the Pharmacokinetics of Atazanavir/Ritonavir/Tenofovir in Healthy Subjects |
Study Start Date : | April 2006 |
Actual Primary Completion Date : | June 2006 |
Actual Study Completion Date : | June 2006 |

Arm | Intervention/treatment |
---|---|
Active Comparator: A |
Drug: Atazanavir+Ritonavir+Tenofovir
Cap/Cap/Tablet, Oral, 300/100/300 mg, QAM/QAM/QAM, 10 days.
Other Name: Abilify
|
Experimental: B |
Drug: Atazanavir+Ritonavir+Tenofovir+Famotidine
Cap/Cap/Tablet/Tablet, Oral, 300/100/300/20 mg, QAM/QAM/QAM/Q12 coadmin, 7 days.
Other Name: Abilify
|
Experimental: C |
Drug: Atazanavir+Ritonavir+Tenofovir+Famotidine
Cap/Cap/Tablet/Tablet, Oral, 300/100/300/20 mg, QAM/QAM/QAM/Q12 2 hr post, 7 days.
Other Name: Abilify
|
Experimental: D |
Drug: Atazanavir+Ritonavir+Tenofovir+Famotidine
Cap/Cap/Tablet/Tablet, Oral, 300/100/300/40 mg, QAM/QAM/QAM/QPM 12 hr post, 7 days.
Other Name: Abilify
|
Experimental: E |
Drug: Atazanavir+Ritonavir+Tenofovir+Famotidine
Cap/Cap/Tablet/Tablet, Oral, 300/100/300/40 mg, QAM/QAM/QAM/Q12 2 hr post,7 days.
Other Name: Abilify
|
- Assess PK of ATV, identifying dosing regimens of ATV/RTV/TDF when dosed with FAM that result in ATV exposures similar to ATV/RTV/TDF 300/100/300 mg with and without FAM.
- Assess PK , safety, and tolerability of ATV/RTV/TDF with and without FAM.

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Ages Eligible for Study: | 18 Years to 50 Years (Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
- Healthy male and female subjects between the ages 18 to 50 years old with a BMI 18 to 32 kg/m2

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): NCT00365339
United States, New Jersey | |
Local Institution | |
Hamilton, New Jersey, United States |
Study Director: | Bristol-Myers Squibb | Bristol-Myers Squibb |
Additional Information:
ClinicalTrials.gov Identifier: | NCT00365339 History of Changes |
Other Study ID Numbers: |
AI424-287 |
First Posted: | August 17, 2006 Key Record Dates |
Last Update Posted: | April 8, 2011 |
Last Verified: | January 2009 |
Keywords provided by Bristol-Myers Squibb:
HIV Protease Inhibitor |
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 Aripiprazole 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 |