Trial Outcomes & Findings for Effects of Famotidine on the Pharmacokinetics of Atazanavir When Coadministered to Participants With HIV Infection (NCT NCT01232127)
NCT ID: NCT01232127
Last Updated: 2012-08-31
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
25 participants
Primary outcome timeframe
Days 10, 11, 17, 18, 24, and 25 (end of study) and at study discharge for those who discontinued prematurely.
Results posted on
2012-08-31
Participant Flow
Participant milestones
| Measure |
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.
|
|---|---|---|---|
|
Period 1: Days 1-10
STARTED
|
25
|
0
|
0
|
|
Period 1: Days 1-10
COMPLETED
|
24
|
0
|
0
|
|
Period 1: Days 1-10
NOT COMPLETED
|
1
|
0
|
0
|
|
Period 2: Days 11-17
STARTED
|
0
|
24
|
0
|
|
Period 2: Days 11-17
COMPLETED
|
0
|
24
|
0
|
|
Period 2: Days 11-17
NOT COMPLETED
|
0
|
0
|
0
|
|
Period 3: Days 18-24
STARTED
|
0
|
0
|
24
|
|
Period 3: Days 18-24
COMPLETED
|
0
|
0
|
24
|
|
Period 3: Days 18-24
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
| Measure |
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.
|
|---|---|---|---|
|
Period 1: Days 1-10
Discontinued due to dosing error
|
1
|
0
|
0
|
Baseline Characteristics
Effects of Famotidine on the Pharmacokinetics of Atazanavir When Coadministered to Participants With HIV Infection
Baseline characteristics by cohort
| Measure |
All Treated
n=25 Participants
|
|---|---|
|
Age, Customized
Younger than 65 years
|
25 Participants
n=5 Participants
|
|
Age, Customized
65 years and older
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
24 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
5 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
20 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Age
|
39.8 Years
n=5 Participants
|
|
CD4 Absolute Count
|
584.8 Cells/μL
STANDARD_DEVIATION 194.09 • n=5 Participants
|
|
CD4 Percent of Total
|
32.1 Percent of participants
STANDARD_DEVIATION 7.10 • n=5 Participants
|
PRIMARY outcome
Timeframe: Days 10, 11, 17, 18, 24, and 25 (end of study) and at study discharge for those who discontinued prematurely.Population: Participants who received study drug and had adequate PK profiles.
Outcome measures
| Measure |
Atazanavir/Ritonavir (300/100) + TDF + ≥NRTI
n=25 Participants
Participants received atazanavir/ritonavir, 300/100 mg QD, plus tenofovir (TDF), 300 mg QD, and at least 1 nucleoside reverse transcriptase inhibitor (NRTI) on Days 1 through 10. 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)
n=24 Participants
Participants received atazanavir/ritonavir, 400/100 mg QD, plus TDF, 300 mg QD, plus at least 1 NRTI, plus famotidine, 20 mg BID on Days 11 through 17. 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)
n=24 Participants
Participants received atazanavir/ritonavir, 400/100 mg QD, plus TDF, 300 mg QD, plus at least 1 NRTI, plus famotidine, 40 mg BID on Days 18 through 24. Atazanavir/ritonavir and TDF were administered with food. The AM dose of famotidine was administered simultaneously with atazanavir/ritonavir/TDF.
|
|---|---|---|---|
|
Maximum Observed Plasma Concentration (Cmax) and Trough Observed Plasma Concentration (Ctrough) for Atazanavir and Ritonavir
Atazanavir Cmax
|
3512 ng/mL
Geometric Coefficient of Variation 35.4
|
4131 ng/mL
Geometric Coefficient of Variation 37.7
|
3322 ng/mL
Geometric Coefficient of Variation 45.2
|
|
Maximum Observed Plasma Concentration (Cmax) and Trough Observed Plasma Concentration (Ctrough) for Atazanavir and Ritonavir
Atazanavir Ctrough
|
496 ng/mL
Geometric Coefficient of Variation 50.9
|
602 ng/mL
Geometric Coefficient of Variation 60.3
|
494 ng/mL
Geometric Coefficient of Variation 59.4
|
|
Maximum Observed Plasma Concentration (Cmax) and Trough Observed Plasma Concentration (Ctrough) for Atazanavir and Ritonavir
Ritonavir Cmax
|
1141 ng/mL
Geometric Coefficient of Variation 30.5
|
1148 ng/mL
Geometric Coefficient of Variation 29.8
|
1096 ng/mL
Geometric Coefficient of Variation 36.1
|
|
Maximum Observed Plasma Concentration (Cmax) and Trough Observed Plasma Concentration (Ctrough) for Atazanavir and Ritonavir
Ritonavir Ctrough
|
45.8 ng/mL
Geometric Coefficient of Variation 58.7
|
49.2 ng/mL
Geometric Coefficient of Variation 66.8
|
47.3 ng/mL
Geometric Coefficient of Variation 53.4
|
PRIMARY outcome
Timeframe: Days 10, 11, 17, 18, 24, and 25 (end of study) and at study discharge for those who discontinued prematurely.Population: Participants who received study drug and had adequate PK profiles.
Outcome measures
| Measure |
Atazanavir/Ritonavir (300/100) + TDF + ≥NRTI
n=25 Participants
Participants received atazanavir/ritonavir, 300/100 mg QD, plus tenofovir (TDF), 300 mg QD, and at least 1 nucleoside reverse transcriptase inhibitor (NRTI) on Days 1 through 10. 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)
n=24 Participants
Participants received atazanavir/ritonavir, 400/100 mg QD, plus TDF, 300 mg QD, plus at least 1 NRTI, plus famotidine, 20 mg BID on Days 11 through 17. 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)
n=24 Participants
Participants received atazanavir/ritonavir, 400/100 mg QD, plus TDF, 300 mg QD, plus at least 1 NRTI, plus famotidine, 40 mg BID on Days 18 through 24. Atazanavir/ritonavir and TDF were administered with food. The AM dose of famotidine was administered simultaneously with atazanavir/ritonavir/TDF.
|
|---|---|---|---|
|
Time of Maximum Observed Plasma Concentration (Tmax) for Atazanavir and Ritonavir
Atazanavir Tmax
|
3.0 Hours
Interval 2.0 to 4.0
|
3.0 Hours
Interval 2.0 to 4.0
|
3.0 Hours
Interval 2.0 to 4.1
|
|
Time of Maximum Observed Plasma Concentration (Tmax) for Atazanavir and Ritonavir
Ritonavir Tmax
|
4.0 Hours
Interval 2.0 to 4.2
|
4.00 Hours
Interval 2.0 to 6.0
|
4.0 Hours
Interval 2.0 to 6.0
|
PRIMARY outcome
Timeframe: Days 10, 11, 17, 18, 24, and 25 (end of study) and at study discharge for those who discontinued prematurely.Population: Participants who received study drug and had adequate PK profiles.
Outcome measures
| Measure |
Atazanavir/Ritonavir (300/100) + TDF + ≥NRTI
n=25 Participants
Participants received atazanavir/ritonavir, 300/100 mg QD, plus tenofovir (TDF), 300 mg QD, and at least 1 nucleoside reverse transcriptase inhibitor (NRTI) on Days 1 through 10. 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)
n=24 Participants
Participants received atazanavir/ritonavir, 400/100 mg QD, plus TDF, 300 mg QD, plus at least 1 NRTI, plus famotidine, 20 mg BID on Days 11 through 17. 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)
n=24 Participants
Participants received atazanavir/ritonavir, 400/100 mg QD, plus TDF, 300 mg QD, plus at least 1 NRTI, plus famotidine, 40 mg BID on Days 18 through 24. Atazanavir/ritonavir and TDF were administered with food. The AM dose of famotidine was administered simultaneously with atazanavir/ritonavir/TDF.
|
|---|---|---|---|
|
Area Under the Plasma Concentration-time Curve in 1 Dosing Interval (Time 0 to 24 Hours Postdose) (AUC[TAU]) for Atazanavir and Ritonavir
Atazanavir AUC
|
32562 ng*h/mL
Geometric Coefficient of Variation 37.7
|
37894 ng*h/mL
Geometric Coefficient of Variation 40.7
|
31481 ng*h/mL
Geometric Coefficient of Variation 48.8
|
|
Area Under the Plasma Concentration-time Curve in 1 Dosing Interval (Time 0 to 24 Hours Postdose) (AUC[TAU]) for Atazanavir and Ritonavir
Ritonavir AUC
|
7317 ng*h/mL
Geometric Coefficient of Variation 35.6
|
7430 ng*h/mL
Geometric Coefficient of Variation 32.4
|
7052 ng*h/mL
Geometric Coefficient of Variation 36.7
|
SECONDARY outcome
Timeframe: Days 1 through 25 (end of study), continuously, and at study discharge for those who discontinued prematurely.Population: Participants who received study drug and were evaluable.
An AE is any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that does not necessarily have a causal relationship with treatment. An SAE is any unfavorable medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency or abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization.
Outcome measures
| Measure |
Atazanavir/Ritonavir (300/100) + TDF + ≥NRTI
n=25 Participants
Participants received atazanavir/ritonavir, 300/100 mg QD, plus tenofovir (TDF), 300 mg QD, and at least 1 nucleoside reverse transcriptase inhibitor (NRTI) on Days 1 through 10. 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)
n=25 Participants
Participants received atazanavir/ritonavir, 400/100 mg QD, plus TDF, 300 mg QD, plus at least 1 NRTI, plus famotidine, 20 mg BID on Days 11 through 17. 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)
n=24 Participants
Participants received atazanavir/ritonavir, 400/100 mg QD, plus TDF, 300 mg QD, plus at least 1 NRTI, plus famotidine, 40 mg BID on Days 18 through 24. Atazanavir/ritonavir and TDF were administered with food. The AM dose of famotidine was administered simultaneously with atazanavir/ritonavir/TDF.
|
|---|---|---|---|
|
Number of Participants With Death as Outcome, Serious Adverse Events (SAEs), Adverse Events (AEs) Leading to Discontinuation, AES, and AEs of Clinical Interest
AEs leading to discontinuation
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Death as Outcome, Serious Adverse Events (SAEs), Adverse Events (AEs) Leading to Discontinuation, AES, and AEs of Clinical Interest
Deaths
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Death as Outcome, Serious Adverse Events (SAEs), Adverse Events (AEs) Leading to Discontinuation, AES, and AEs of Clinical Interest
SAEs
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Death as Outcome, Serious Adverse Events (SAEs), Adverse Events (AEs) Leading to Discontinuation, AES, and AEs of Clinical Interest
AEs
|
6 Participants
|
7 Participants
|
5 Participants
|
|
Number of Participants With Death as Outcome, Serious Adverse Events (SAEs), Adverse Events (AEs) Leading to Discontinuation, AES, and AEs of Clinical Interest
AEs of clinical interest: Nausea
|
0 Participants
|
2 Participants
|
0 Participants
|
|
Number of Participants With Death as Outcome, Serious Adverse Events (SAEs), Adverse Events (AEs) Leading to Discontinuation, AES, and AEs of Clinical Interest
AEs of clinical interest: Diarrhea
|
0 Participants
|
3 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Days 1, 11, 18, and 25 (end of study) and at study discharge for those who discontinued prematurely.Population: Participants who received study drug and were evaluable.
Vital signs include temperature, respiratory rate, seated blood pressure, and heart rate.
Outcome measures
| Measure |
Atazanavir/Ritonavir (300/100) + TDF + ≥NRTI
n=25 Participants
Participants received atazanavir/ritonavir, 300/100 mg QD, plus tenofovir (TDF), 300 mg QD, and at least 1 nucleoside reverse transcriptase inhibitor (NRTI) on Days 1 through 10. 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 on Days 11 through 17. 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 on Days 18 through 24. Atazanavir/ritonavir and TDF were administered with food. The AM dose of famotidine was administered simultaneously with atazanavir/ritonavir/TDF.
|
|---|---|---|---|
|
Number of Participants With Abnormalities in Vital Signs
Isolated decrease in heart rate
|
2 Participants
|
—
|
—
|
|
Number of Participants With Abnormalities in Vital Signs
Sporadic respiration rate >16 bpm
|
11 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: Days 1 and 25 (end of study) and at study discharge for those who discontinued prematurely.Population: Participants who received study drug and were evaluable.
ECG findings include heart rate, ECG intervals (including PR, QRS, QT, and corrections to QT using both Bazett's and Fridericia's formulae), and Investigator-identified ECG abnormalities.
Outcome measures
| Measure |
Atazanavir/Ritonavir (300/100) + TDF + ≥NRTI
n=25 Participants
Participants received atazanavir/ritonavir, 300/100 mg QD, plus tenofovir (TDF), 300 mg QD, and at least 1 nucleoside reverse transcriptase inhibitor (NRTI) on Days 1 through 10. 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 on Days 11 through 17. 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 on Days 18 through 24. Atazanavir/ritonavir and TDF were administered with food. The AM dose of famotidine was administered simultaneously with atazanavir/ritonavir/TDF.
|
|---|---|---|---|
|
Number of Participants With Abnormalities in Electrocardiogram (ECG) Findings
Nonspecific ST/T wave abnormality
|
1 Participants
|
—
|
—
|
|
Number of Participants With Abnormalities in Electrocardiogram (ECG) Findings
Short PR interval
|
1 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: Days 11, 18, and 25 (end of study) and at study discharge for those who discontinued prematurely.Population: Participants who received study drug and were evaluable.
PreRX=pretreatment; ULN=upper limit of normal. Neutrophils, (absolute), low (10\*3 c/uL): \<0.85\*PreRx, if PreRx \<1.5; \<1.5 if PreRx ≥1.5. Alanine aminotransferase, high (U/L): \>1.25\*PreRx if PreRx \>ULN; \>1.25\*ULN if PreRx ≤ULN. Bilirubin, direct (mg/dL), high: \>1.1\*ULN if PreRx ≤ULN;\> 1.1\*ULN if PreRx is missing; \>1.25\*PreRx if PreRx \>ULN. Bilirubin, total (mg/dL), high: \>1.1\*ULN if PreRx ≤ULN;\> 1.1\*ULN if PreRx is missing; \>1.25\*PreRx if PreRx \>ULN.
Outcome measures
| Measure |
Atazanavir/Ritonavir (300/100) + TDF + ≥NRTI
n=25 Participants
Participants received atazanavir/ritonavir, 300/100 mg QD, plus tenofovir (TDF), 300 mg QD, and at least 1 nucleoside reverse transcriptase inhibitor (NRTI) on Days 1 through 10. 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)
n=24 Participants
Participants received atazanavir/ritonavir, 400/100 mg QD, plus TDF, 300 mg QD, plus at least 1 NRTI, plus famotidine, 20 mg BID on Days 11 through 17. 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)
n=23 Participants
Participants received atazanavir/ritonavir, 400/100 mg QD, plus TDF, 300 mg QD, plus at least 1 NRTI, plus famotidine, 40 mg BID on Days 18 through 24. Atazanavir/ritonavir and TDF were administered with food. The AM dose of famotidine was administered simultaneously with atazanavir/ritonavir/TDF.
|
|---|---|---|---|
|
Number of Participants With Abnormalities in Laboratory Test Results
Alanine aminotransferase (high)
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Abnormalities in Laboratory Test Results
Aspartate aminotransferase (high)
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Abnormalities in Laboratory Test Results
WBC differential count (low)
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Abnormalities in Laboratory Test Results
Neutrophils (absolute) (low)
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Abnormalities in Laboratory Test Results
Bilirubin, direct (high)
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Abnormalities in Laboratory Test Results
Bilirubin, total (high)
|
3 Participants
|
7 Participants
|
5 Participants
|
Adverse Events
Atazanavir/Ritonavir (300/100) + TDF + ≥NRTI
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Atazanavir/Ritonavir (400/100) + TDF + ≥NRTI + Famotidine (20)
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Atazanavir/Ritonavir (400/100) + TDF + ≥NRTI + Famotidine (40)
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Atazanavir/Ritonavir (300/100) + TDF + ≥NRTI
n=25 participants at risk
Participants received atazanavir/ritonavir, 300/100 mg once daily (QD), plus tenofovir (TDF), 300 mg QD, and at least 1 nucleoside reverse transcriptase inhibitor (NRTI) on Days 1 through 10. 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)
n=25 participants at risk
Participants received atazanavir/ritonavir, 400/100 mg QD, plus TDF, 300 mg QD, plus at least 1 NRTI, plus famotidine, 20 mg twice daily (BID) on Days 11 through 17. 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)
n=24 participants at risk
Participants received atazanavir/ritonavir, 400/100 mg QD, plus TDF, 300 mg QD, plus at least 1 NRTI, plus famotidine, 40 mg BID on Days 18 through 24. Atazanavir/ritonavir and TDF were administered with food. The AM dose of famotidine was administered simultaneously with atazanavir/ritonavir/TDF
|
|---|---|---|---|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/25 • Days 1 through 25 (end of study), continuously, and at study discharge for those who discontinued prematurely.
|
12.0%
3/25 • Days 1 through 25 (end of study), continuously, and at study discharge for those who discontinued prematurely.
|
0.00%
0/24 • Days 1 through 25 (end of study), continuously, and at study discharge for those who discontinued prematurely.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/25 • Days 1 through 25 (end of study), continuously, and at study discharge for those who discontinued prematurely.
|
8.0%
2/25 • Days 1 through 25 (end of study), continuously, and at study discharge for those who discontinued prematurely.
|
0.00%
0/24 • Days 1 through 25 (end of study), continuously, and at study discharge for those who discontinued prematurely.
|
|
Nervous system disorders
Headache
|
16.0%
4/25 • Days 1 through 25 (end of study), continuously, and at study discharge for those who discontinued prematurely.
|
4.0%
1/25 • Days 1 through 25 (end of study), continuously, and at study discharge for those who discontinued prematurely.
|
4.2%
1/24 • Days 1 through 25 (end of study), continuously, and at study discharge for those who discontinued prematurely.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Bristol-Myers Squibb Co. agreements with investigators vary; constant is our right to embargo communications regarding trial results prior to public release for a period ≤60 days from submittal for review. We will not prohibit investigators from publishing, but will prohibit the disclosure of previously undisclosed confidential information other than study results, and request postponement of single-center publications until after disclosure of the clinical trial's primary publication.
- Publication restrictions are in place
Restriction type: OTHER