HIV
Conditions
Brief summary
The purpose of this study is to assess the effects of famotidine, given twice daily, on atazanavir administered with ritonavir and tenofovir in HIV-infected participants.
Detailed description
This protocol was designed to compare the pharmacokinetic parameters of atazanavir administered as atazanavir/ritonavir, 400/100 mg once daily (QD), plus famotidine, 20 mg and 40 mg twice daily, with the parameters found at the usual clinical dose of atazanavir/ritonavir, 300/100 mg QD, without famotidine in HIV-infected participants receiving tenofovir disoproxil fumarate and at least 1 other nucleoside reverse transcriptase inhibitor.
Interventions
DRUGAtazanavir
Capsule, oral, 300 mg, once daily, 10 days
DRUGRitonavir
Capsule, oral, 100 mg, once daily, 10 days
DRUGTenofovir (TDF)
Capsule, oral, 300 mg, once daily, 10 days
Oral, 10 days
DRUGFamotidine (FAM)
Tablet, oral, 20 mg, twice daily, 7 days
Sponsors
Bristol-Myers Squibb
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
Key inclusion criteria: * Males and females, 18 to 65 years of age, with HIV infection and a body mass index of 18.0 to 35.0 kg/m\^2 * HIV-infected participants receiving a treatment regimen containing only atazanavir/ritonavir, 300/100 mg once daily (QD) + tenofovir, 300 mg QD + at least 1 other nucleotide reverse transcriptase inhibitor continuously for at least 3 months prior to study day 1 * Plasma HIV RNA levels of \<50 copies/mL and a CD4 count \>200 cells/mm\^3. * No history of virologic failure on a protease inhibitor (PI), documented phenotypic PI resistance, or primary PI mutations, according to International AIDS Society recommendations * No documented phenotypic resistance to atazanavir or primary genotypic mutations causing resistance to atazanavir * Women of childbearing potential who were not nursing or pregnant and were using an acceptable method of contraception for at least 4 weeks before dosing, during the study, and for 8 weeks from the last dose of study drug. * Women with a negative pregnancy test result within 24 hours prior to dosing with study medication * Women not breastfeeding * Men willing or able to agree to practice barrier contraception for the duration of the study and at least 3 months after dosing. Key
Exclusion criteria
* Any history of CD4 cell count \<50 cells/mm\^3 * Previously documented phenotypic or genotypic resistance to any of the currently prescribed NRTIs * Any significant acute illness within 6 months of study day 1 or chronic medical illness unless stable or controlled by a nonprohibited medication * Any major surgery within 4 weeks of study day 1 * Any gastrointestinal surgery that could impact upon the absorption of any study drug * Inability to be venipunctured and/or tolerate venous access * History of Gilbert's syndrome, hemophilia, chronic pancreatitis, hypochlorhydria, achlorhydria, clinically relevant gastroesophageal reflux disease, hiatal hernia, or peptic/gastric ulcer disease * Intractable diarrhea (≥ 6 loose stools/day for at least 7 consecutive days) within 30 days prior to study day 1 * Recent (within 6 months prior to study day 1) drug or alcohol abuse * Evidence of organ dysfunction or any clinically significant deviation from normal in physical examination, vital signs, electrocardiogram (ECG) * Evidence of organ dysfunction or any clinically significant deviation from normal in physical examination, vital signs, ECG, or clinical laboratory determinations, which would not be expected for the extent of HIV disease * Any of the following on 12-lead ECG prior to dosing on study day 1, confirmed by repeat: PR ≥ 210 msec; QRS ≥ 120 msec; QT ≥ 500 msec; QTcF ≥ 450 msec * Second- or third-degree A-V block or clinically relevant ECG abnormalities * Positive urine screen for drugs of abuse at screening or prior to dosing without a valid prescription. Positive urine drug screen for cannabinoids with or without a prescription is not exclusionary * Creatinine clearance, as estimated by method of Cockcroft and Gault, less than 60 mL/min * Liver enzyme levels \> 3\* the upper limit of normal (ULN) prior to dosing on study day 1 * Total bilirubin level \>10\*ULN prior to study day 1 * Positive blood screen for hepatitis B surface antigen or hepatitis C antibody.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Maximum Observed Plasma Concentration (Cmax) and Trough Observed Plasma Concentration (Ctrough) for Atazanavir and Ritonavir | Days 10, 11, 17, 18, 24, and 25 (end of study) and at study discharge for those who discontinued prematurely. |
| Time of Maximum Observed Plasma Concentration (Tmax) for Atazanavir and Ritonavir | Days 10, 11, 17, 18, 24, and 25 (end of study) and at study discharge for those who discontinued prematurely. |
| Area Under the Plasma Concentration-time Curve in 1 Dosing Interval (Time 0 to 24 Hours Postdose) (AUC[TAU]) for Atazanavir and Ritonavir | Days 10, 11, 17, 18, 24, and 25 (end of study) and at study discharge for those who discontinued prematurely. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Death as Outcome, Serious Adverse Events (SAEs), Adverse Events (AEs) Leading to Discontinuation, AES, and AEs of Clinical Interest | Days 1 through 25 (end of study), continuously, and at study discharge for those who discontinued prematurely. | 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. |
| Number of Participants With Abnormalities in Laboratory Test Results | Days 11, 18, and 25 (end of study) and at study discharge for those who discontinued prematurely. | 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. |
| Number of Participants With Abnormalities in Vital Signs | Days 1, 11, 18, and 25 (end of study) and at study discharge for those who discontinued prematurely. | Vital signs include temperature, respiratory rate, seated blood pressure, and heart rate. |
| Number of Participants With Abnormalities in Electrocardiogram (ECG) Findings | Days 1 and 25 (end of study) and at study discharge for those who discontinued prematurely. | 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. |
Countries
Germany, United Kingdom
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| All Treated | 25 |
| Total | 25 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Period 1: Days 1-10 | Discontinued due to dosing error | 1 | 0 | 0 |
Baseline characteristics
| Characteristic | All Treated |
|---|---|
| Age | 39.8 Years |
| Age, Customized 65 years and older | 0 Participants |
| Age, Customized Younger than 65 years | 25 Participants |
| CD4 Absolute Count | 584.8 Cells/μL STANDARD_DEVIATION 194.09 |
| CD4 Percent of Total | 32.1 Percent of participants STANDARD_DEVIATION 7.1 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 5 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 20 Participants |
| Sex: Female, Male Female | 1 Participants |
| Sex: Female, Male Male | 24 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 4 / 25 | 6 / 25 | 1 / 24 |
| serious Total, serious adverse events | 0 / 25 | 0 / 25 | 0 / 24 |
Outcome results
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.
Population: Participants who received study drug and had adequate PK profiles.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| Atazanavir/Ritonavir (300/100) + TDF + ≥NRTI | 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 |
| Atazanavir/Ritonavir (300/100) + TDF + ≥NRTI | 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 |
| Atazanavir/Ritonavir (400/100) + TDF + ≥NRTI + Famotidine (20) | 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 | 37894 ng*h/mL | Geometric Coefficient of Variation 40.7 |
| Atazanavir/Ritonavir (400/100) + TDF + ≥NRTI + Famotidine (20) | 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 | 7430 ng*h/mL | Geometric Coefficient of Variation 32.4 |
| Atazanavir/Ritonavir (400/100) + TDF + ≥NRTI + Famotidine (40) | 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 | 31481 ng*h/mL | Geometric Coefficient of Variation 48.8 |
| Atazanavir/Ritonavir (400/100) + TDF + ≥NRTI + Famotidine (40) | 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 | 7052 ng*h/mL | Geometric Coefficient of Variation 36.7 |
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.
Population: Participants who received study drug and had adequate PK profiles.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| Atazanavir/Ritonavir (300/100) + TDF + ≥NRTI | 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 |
| Atazanavir/Ritonavir (300/100) + TDF + ≥NRTI | 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 |
| Atazanavir/Ritonavir (300/100) + TDF + ≥NRTI | 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 |
| Atazanavir/Ritonavir (300/100) + TDF + ≥NRTI | 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 |
| Atazanavir/Ritonavir (400/100) + TDF + ≥NRTI + Famotidine (20) | Maximum Observed Plasma Concentration (Cmax) and Trough Observed Plasma Concentration (Ctrough) for Atazanavir and Ritonavir | Ritonavir Cmax | 1148 ng/mL | Geometric Coefficient of Variation 29.8 |
| Atazanavir/Ritonavir (400/100) + TDF + ≥NRTI + Famotidine (20) | Maximum Observed Plasma Concentration (Cmax) and Trough Observed Plasma Concentration (Ctrough) for Atazanavir and Ritonavir | Atazanavir Ctrough | 602 ng/mL | Geometric Coefficient of Variation 60.3 |
| Atazanavir/Ritonavir (400/100) + TDF + ≥NRTI + Famotidine (20) | Maximum Observed Plasma Concentration (Cmax) and Trough Observed Plasma Concentration (Ctrough) for Atazanavir and Ritonavir | Ritonavir Ctrough | 49.2 ng/mL | Geometric Coefficient of Variation 66.8 |
| Atazanavir/Ritonavir (400/100) + TDF + ≥NRTI + Famotidine (20) | Maximum Observed Plasma Concentration (Cmax) and Trough Observed Plasma Concentration (Ctrough) for Atazanavir and Ritonavir | Atazanavir Cmax | 4131 ng/mL | Geometric Coefficient of Variation 37.7 |
| Atazanavir/Ritonavir (400/100) + TDF + ≥NRTI + Famotidine (40) | Maximum Observed Plasma Concentration (Cmax) and Trough Observed Plasma Concentration (Ctrough) for Atazanavir and Ritonavir | Ritonavir Ctrough | 47.3 ng/mL | Geometric Coefficient of Variation 53.4 |
| Atazanavir/Ritonavir (400/100) + TDF + ≥NRTI + Famotidine (40) | Maximum Observed Plasma Concentration (Cmax) and Trough Observed Plasma Concentration (Ctrough) for Atazanavir and Ritonavir | Atazanavir Cmax | 3322 ng/mL | Geometric Coefficient of Variation 45.2 |
| Atazanavir/Ritonavir (400/100) + TDF + ≥NRTI + Famotidine (40) | Maximum Observed Plasma Concentration (Cmax) and Trough Observed Plasma Concentration (Ctrough) for Atazanavir and Ritonavir | Atazanavir Ctrough | 494 ng/mL | Geometric Coefficient of Variation 59.4 |
| Atazanavir/Ritonavir (400/100) + TDF + ≥NRTI + Famotidine (40) | Maximum Observed Plasma Concentration (Cmax) and Trough Observed Plasma Concentration (Ctrough) for Atazanavir and Ritonavir | Ritonavir Cmax | 1096 ng/mL | Geometric Coefficient of Variation 36.1 |
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.
Population: Participants who received study drug and had adequate PK profiles.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Atazanavir/Ritonavir (300/100) + TDF + ≥NRTI | Time of Maximum Observed Plasma Concentration (Tmax) for Atazanavir and Ritonavir | Atazanavir Tmax | 3.0 Hours |
| Atazanavir/Ritonavir (300/100) + TDF + ≥NRTI | Time of Maximum Observed Plasma Concentration (Tmax) for Atazanavir and Ritonavir | Ritonavir Tmax | 4.0 Hours |
| Atazanavir/Ritonavir (400/100) + TDF + ≥NRTI + Famotidine (20) | Time of Maximum Observed Plasma Concentration (Tmax) for Atazanavir and Ritonavir | Atazanavir Tmax | 3.0 Hours |
| Atazanavir/Ritonavir (400/100) + TDF + ≥NRTI + Famotidine (20) | Time of Maximum Observed Plasma Concentration (Tmax) for Atazanavir and Ritonavir | Ritonavir Tmax | 4.00 Hours |
| Atazanavir/Ritonavir (400/100) + TDF + ≥NRTI + Famotidine (40) | Time of Maximum Observed Plasma Concentration (Tmax) for Atazanavir and Ritonavir | Atazanavir Tmax | 3.0 Hours |
| Atazanavir/Ritonavir (400/100) + TDF + ≥NRTI + Famotidine (40) | Time of Maximum Observed Plasma Concentration (Tmax) for Atazanavir and Ritonavir | Ritonavir Tmax | 4.0 Hours |
Secondary
Number of Participants With Abnormalities in Electrocardiogram (ECG) Findings
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.
Time frame: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Atazanavir/Ritonavir (300/100) + TDF + ≥NRTI | Number of Participants With Abnormalities in Electrocardiogram (ECG) Findings | Nonspecific ST/T wave abnormality | 1 Participants |
| Atazanavir/Ritonavir (300/100) + TDF + ≥NRTI | Number of Participants With Abnormalities in Electrocardiogram (ECG) Findings | Short PR interval | 1 Participants |
Secondary
Number of Participants With Abnormalities in Laboratory Test Results
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.
Time frame: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Atazanavir/Ritonavir (300/100) + TDF + ≥NRTI | Number of Participants With Abnormalities in Laboratory Test Results | WBC differential count (low) | 1 Participants |
| Atazanavir/Ritonavir (300/100) + TDF + ≥NRTI | Number of Participants With Abnormalities in Laboratory Test Results | Neutrophils (absolute) (low) | 0 Participants |
| Atazanavir/Ritonavir (300/100) + TDF + ≥NRTI | Number of Participants With Abnormalities in Laboratory Test Results | Alanine aminotransferase (high) | 0 Participants |
| Atazanavir/Ritonavir (300/100) + TDF + ≥NRTI | Number of Participants With Abnormalities in Laboratory Test Results | Aspartate aminotransferase (high) | 0 Participants |
| Atazanavir/Ritonavir (300/100) + TDF + ≥NRTI | Number of Participants With Abnormalities in Laboratory Test Results | Bilirubin, direct (high) | 1 Participants |
| Atazanavir/Ritonavir (300/100) + TDF + ≥NRTI | Number of Participants With Abnormalities in Laboratory Test Results | Bilirubin, total (high) | 3 Participants |
| Atazanavir/Ritonavir (400/100) + TDF + ≥NRTI + Famotidine (20) | Number of Participants With Abnormalities in Laboratory Test Results | Bilirubin, total (high) | 7 Participants |
| Atazanavir/Ritonavir (400/100) + TDF + ≥NRTI + Famotidine (20) | Number of Participants With Abnormalities in Laboratory Test Results | WBC differential count (low) | 0 Participants |
| Atazanavir/Ritonavir (400/100) + TDF + ≥NRTI + Famotidine (20) | Number of Participants With Abnormalities in Laboratory Test Results | Aspartate aminotransferase (high) | 0 Participants |
| Atazanavir/Ritonavir (400/100) + TDF + ≥NRTI + Famotidine (20) | Number of Participants With Abnormalities in Laboratory Test Results | Bilirubin, direct (high) | 0 Participants |
| Atazanavir/Ritonavir (400/100) + TDF + ≥NRTI + Famotidine (20) | Number of Participants With Abnormalities in Laboratory Test Results | Neutrophils (absolute) (low) | 1 Participants |
| Atazanavir/Ritonavir (400/100) + TDF + ≥NRTI + Famotidine (20) | Number of Participants With Abnormalities in Laboratory Test Results | Alanine aminotransferase (high) | 1 Participants |
| Atazanavir/Ritonavir (400/100) + TDF + ≥NRTI + Famotidine (40) | Number of Participants With Abnormalities in Laboratory Test Results | Neutrophils (absolute) (low) | 0 Participants |
| Atazanavir/Ritonavir (400/100) + TDF + ≥NRTI + Famotidine (40) | Number of Participants With Abnormalities in Laboratory Test Results | Alanine aminotransferase (high) | 0 Participants |
| Atazanavir/Ritonavir (400/100) + TDF + ≥NRTI + Famotidine (40) | Number of Participants With Abnormalities in Laboratory Test Results | Bilirubin, total (high) | 5 Participants |
| Atazanavir/Ritonavir (400/100) + TDF + ≥NRTI + Famotidine (40) | Number of Participants With Abnormalities in Laboratory Test Results | Aspartate aminotransferase (high) | 1 Participants |
| Atazanavir/Ritonavir (400/100) + TDF + ≥NRTI + Famotidine (40) | Number of Participants With Abnormalities in Laboratory Test Results | WBC differential count (low) | 0 Participants |
| Atazanavir/Ritonavir (400/100) + TDF + ≥NRTI + Famotidine (40) | Number of Participants With Abnormalities in Laboratory Test Results | Bilirubin, direct (high) | 0 Participants |
Secondary
Number of Participants With Abnormalities in Vital Signs
Vital signs include temperature, respiratory rate, seated blood pressure, and heart rate.
Time frame: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Atazanavir/Ritonavir (300/100) + TDF + ≥NRTI | Number of Participants With Abnormalities in Vital Signs | Isolated decrease in heart rate | 2 Participants |
| Atazanavir/Ritonavir (300/100) + TDF + ≥NRTI | Number of Participants With Abnormalities in Vital Signs | Sporadic respiration rate >16 bpm | 11 Participants |
Secondary
Number of Participants With Death as Outcome, Serious Adverse Events (SAEs), Adverse Events (AEs) Leading to Discontinuation, AES, and AEs of Clinical Interest
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.
Time frame: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Atazanavir/Ritonavir (300/100) + TDF + ≥NRTI | 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 |
| Atazanavir/Ritonavir (300/100) + TDF + ≥NRTI | 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 |
| Atazanavir/Ritonavir (300/100) + TDF + ≥NRTI | 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 |
| Atazanavir/Ritonavir (300/100) + TDF + ≥NRTI | 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 |
| Atazanavir/Ritonavir (300/100) + TDF + ≥NRTI | 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 |
| Atazanavir/Ritonavir (300/100) + TDF + ≥NRTI | 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 |
| Atazanavir/Ritonavir (400/100) + TDF + ≥NRTI + Famotidine (20) | 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 |
| Atazanavir/Ritonavir (400/100) + TDF + ≥NRTI + Famotidine (20) | 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 | 2 Participants |
| Atazanavir/Ritonavir (400/100) + TDF + ≥NRTI + Famotidine (20) | Number of Participants With Death as Outcome, Serious Adverse Events (SAEs), Adverse Events (AEs) Leading to Discontinuation, AES, and AEs of Clinical Interest | AEs | 7 Participants |
| Atazanavir/Ritonavir (400/100) + TDF + ≥NRTI + Famotidine (20) | 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 |
| Atazanavir/Ritonavir (400/100) + TDF + ≥NRTI + Famotidine (20) | 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 | 3 Participants |
| Atazanavir/Ritonavir (400/100) + TDF + ≥NRTI + Famotidine (20) | 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 |
| Atazanavir/Ritonavir (400/100) + TDF + ≥NRTI + Famotidine (40) | 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 |
| Atazanavir/Ritonavir (400/100) + TDF + ≥NRTI + Famotidine (40) | 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 |
| Atazanavir/Ritonavir (400/100) + TDF + ≥NRTI + Famotidine (40) | 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 |
| Atazanavir/Ritonavir (400/100) + TDF + ≥NRTI + Famotidine (40) | Number of Participants With Death as Outcome, Serious Adverse Events (SAEs), Adverse Events (AEs) Leading to Discontinuation, AES, and AEs of Clinical Interest | AEs | 5 Participants |
| Atazanavir/Ritonavir (400/100) + TDF + ≥NRTI + Famotidine (40) | 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 |
| Atazanavir/Ritonavir (400/100) + TDF + ≥NRTI + Famotidine (40) | 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 |