Effects of Famotidine on the Pharmacokinetics of Atazanavir When Coadministered to Participants With HIV Infection

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT01232127
First received: October 29, 2010
Last updated: August 27, 2012
Last verified: August 2012
Results First Received: July 23, 2012  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Endpoint Classification: Pharmacokinetics Study;   Intervention Model: Single Group Assignment;   Masking: Open Label
Condition: HIV
Interventions: Drug: Atazanavir
Drug: Ritonavir
Drug: Tenofovir (TDF)
Drug: Nucleoside Reverse Transcriptase Inhibitor (NRTI)
Drug: Famotidine (FAM)

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Atazanavir/Ritonavir (300/100) + TDF + ≥NRTI Participants received atazanavir/ritonavir, 300/100 mg QD, plus tenofovir (TDF), 300 mg QD, and at least 1 nucleoside reverse transcriptase inhibitor (NRTI). Atazanavir/ritonavir and TDF were administered with food. The AM dose of famotidine was administered simultaneously with atazanavir/ritonavir/TDF.
Atazanavir/Ritonavir (400/100) + TDF + ≥NRTI + Famotidine (20) Participants received atazanavir/ritonavir, 400/100 mg QD, plus TDF, 300 mg QD, plus at least 1 NRTI, plus famotidine, 20 mg BID. Atazanavir/ritonavir and TDF were administered with food. The AM dose of famotidine was administered simultaneously with atazanavir/ritonavir/TDF.
Atazanavir/Ritonavir (400/100) + TDF + ≥NRTI + Famotidine (40) Participants received atazanavir/ritonavir, 400/100 mg QD, plus TDF, 300 mg QD, plus at least 1 NRTI, plus famotidine, 40 mg BID. Atazanavir/ritonavir and TDF were administered with food. The AM dose of famotidine was administered simultaneously with atazanavir/ritonavir/TDF.

Participant Flow for 3 periods

Period 1:   Period 1: Days 1-10
    Atazanavir/Ritonavir (300/100) + TDF + ≥NRTI     Atazanavir/Ritonavir (400/100) + TDF + ≥NRTI + Famotidine (20)     Atazanavir/Ritonavir (400/100) + TDF + ≥NRTI + Famotidine (40)  
STARTED     25 [1]   0     0  
COMPLETED     24     0     0  
NOT COMPLETED     1     0     0  
Discontinued due to dosing error                 1                 0                 0  
[1] Participants who received treatment.

Period 2:   Period 2: Days 11-17
    Atazanavir/Ritonavir (300/100) + TDF + ≥NRTI     Atazanavir/Ritonavir (400/100) + TDF + ≥NRTI + Famotidine (20)     Atazanavir/Ritonavir (400/100) + TDF + ≥NRTI + Famotidine (40)  
STARTED     0     24 [1]   0  
COMPLETED     0     24     0  
NOT COMPLETED     0     0     0  
[1] Participants who received treatment.

Period 3:   Period 3: Days 18-24
    Atazanavir/Ritonavir (300/100) + TDF + ≥NRTI     Atazanavir/Ritonavir (400/100) + TDF + ≥NRTI + Famotidine (20)     Atazanavir/Ritonavir (400/100) + TDF + ≥NRTI + Famotidine (40)  
STARTED     0     0     24 [1]
COMPLETED     0     0     24  
NOT COMPLETED     0     0     0  
[1] Participants who received treatment.



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
All Treated No text entered.

Baseline Measures
    All Treated  
Number of Participants  
[units: participants]
  25  
Age, Customized  
[units: Participants]
 
Younger than 65 years     25  
65 years and older     0  
Gender  
[units: participants]
 
Female     1  
Male     24  
Race (NIH/OMB)  
[units: Participants]
 
American Indian or Alaska Native     0  
Asian     0  
Native Hawaiian or Other Pacific Islander     0  
Black or African American     5  
White     20  
More than one race     0  
Unknown or Not Reported     0  
Age  
[units: Years]
Mean ( Full Range )
  39.8  
  ( 23 to 62 )  
CD4 Absolute Count [1]
[units: Cells/μL]
Mean ± Standard Deviation
  584.8  ± 194.09  
CD4 Percent of Total [2]
[units: Percent of participants]
Mean ± Standard Deviation
  32.1  ± 7.10  
[1] n=23 (n=evaluable participants)
[2] n=23 (n=evaluable participants)For 2 participants, baseline CD4 percent total and absolute count were performed as an unscheduled visit after the initial screening visit and thus, are not included in this summary.



  Outcome Measures
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1.  Primary:   Maximum Observed Plasma Concentration (Cmax) and Trough Observed Plasma Concentration (Ctrough) for Atazanavir and Ritonavir   [ Time Frame: Days 10, 11, 17, 18, 24, and 25 (end of study) and at study discharge for those who discontinued prematurely. ]

2.  Primary:   Time of Maximum Observed Plasma Concentration (Tmax) for Atazanavir and Ritonavir   [ Time Frame: Days 10, 11, 17, 18, 24, and 25 (end of study) and at study discharge for those who discontinued prematurely. ]

3.  Primary:   Area Under the Plasma Concentration-time Curve in 1 Dosing Interval (Time 0 to 24 Hours Postdose) (AUC[TAU]) for Atazanavir and Ritonavir   [ Time Frame: Days 10, 11, 17, 18, 24, and 25 (end of study) and at study discharge for those who discontinued prematurely. ]

4.  Secondary:   Number of Participants With Death as Outcome, Serious Adverse Events (SAEs), Adverse Events (AEs) Leading to Discontinuation, AES, and AEs of Clinical Interest   [ Time Frame: Days 1 through 25 (end of study), continuously, and at study discharge for those who discontinued prematurely. ]

5.  Secondary:   Number of Participants With Abnormalities in Vital Signs   [ Time Frame: Days 1, 11, 18, and 25 (end of study) and at study discharge for those who discontinued prematurely. ]

6.  Secondary:   Number of Participants With Abnormalities in Electrocardiogram (ECG) Findings   [ Time Frame: Days 1 and 25 (end of study) and at study discharge for those who discontinued prematurely. ]

7.  Secondary:   Number of Participants With Abnormalities in Laboratory Test Results   [ Time Frame: Days 11, 18, and 25 (end of study) and at study discharge for those who discontinued prematurely. ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: BMS Study Director
Organization: Bristol-Myers Squibb
e-mail: Clinical.Trials@bms.com


No publications provided


Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT01232127     History of Changes
Other Study ID Numbers: AI424-398, 2009-016981-95
Study First Received: October 29, 2010
Results First Received: July 23, 2012
Last Updated: August 27, 2012
Health Authority: CHMP: Committee for Medicinal Products for Human Use
EMEA: European Medicines Agency