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CompletedNCT00646776Updated Jan 31, 2013Results posted

Drug Interaction Study

A Phase 1 interventional study of Rifabutin and Rifabutin + Atazanavir + Ritonavir in Antivirals/HIV, sponsored by Bristol-Myers Squibb. Completed at 1 site in United States. Open to participants aged 18 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2013-01-31.

Sponsored by Bristol-Myers Squibb · Phase 1, Interventional, and Treatment

Phase
Phase 1
Study type
Interventional
Enrollment
85
Allocation
Randomized
Ages
18 Years to 50 Years
Sex
All
01

Study summary

The purpose of this study is to evaluate the exposure of rifabutin (RIB) when administered with atazanavir and ritonavir (ATV/RTV)

02

Conditions studied

  • Antivirals/HIV
03

In context

Lead sponsor

Bristol-Myers Squibb is the lead sponsor of 1,538 studies on the registry; 116 are open to participants now.

Of its 429 completed or terminated interventional studies of FDA-regulated products, 223 (52%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 50 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • Healthy male and female subjects between the ages of 18 to 50 years old with a body mass index (BMI) of 18 to 32 kg/m²
  • Prior to enrollment, subjects must have physical and laboratory test findings within the normal limits, and women of childbearing potential (WOCBP) must have a negative pregnancy test

Exclusion criteria

Exclusion Criteria:

  • Any significant acute or chronic medical illness
  • Evidence of organ dysfunction or any clinically significant deviation from normal in physical examination, vital signs, electrocardiogram (ECG) or clinical laboratory determinations
  • Use of any prescription drugs or over-the-counter acid controllers within 4 weeks prior to study drug administration
  • Use of any other drugs, including over-the-counter medications of herbal preparations within 1 week prior to study drug administration
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
85 participants (actual)

Study arms

  • Active comparator
    A

    Drug: Rifabutin

  • Active comparator
    B

    Drug: Rifabutin + Atazanavir + Ritonavir

Interventions

  • DrugRifabutin

    Capsule, Oral, 150 mg, once daily, 11 Days

  • DrugRifabutin + Atazanavir + Ritonavir

    Capsules, Oral, 18 Days Rifabutin (150 mg, 2x/wk) Atazanavir (300 mg, once daily) Ritonavir (100 mg, once daily)

    Also known as: Reyataz

06

What researchers measure

Primary outcomes

  1. Average Area Under the Plasma Concentration-time Curve for 24 Hours (AUC24avg) for Rifabutin (RIB)

    AUC24avg is AUC(0-24 hour) following dosing on Day 10 for RIB 150mg once daily (QD); AUC24avg is the area under the plasma concentration-time curve in 1 dosing interval (AUC\[TAU\]) divided by the number of days over the sampling duration for ATV/RTV 300/100 mg QD+RIB 150 mg twice weekly, i.e. AUC(TAU)/7.

    Time frame: Pre-dose (0 hours [h]) on Days 6, 8, 10, and 11, and post-dose (1h,2h,3h,4h,6h,8h,12h) on Day 10 for RIB 150 mg QD; and pre-dose (0h) on Days 4, 8,11 to 18 and post-dose (1h,2h,3h,4h,6h,8h,12h) on Days 11 and 15 for ATV/RTV + RIB.

  2. Maximum Plasma Concentration (Cmax) of RIB

    Cmax was derived from plasma concentration versus time for RIB and was recorded directly from experimental observations for each treatment period.

    Time frame: Pre-dose (0h) on Days 6, 8, 10, and 11, and post-dose (1h,2h,3h,4h,6h,8h,12h) on Day 10 for RIB 150 mg QD; and pre-dose (0h) on Days 4, 8,11 to 18 and post-dose (1h,2h,3h,4h,6h,8h,12h) on Days 11 and 15 for ATV/RTV + RIB.

  3. Minimum Plasma Concentration (Cmin) of RIB

    Cmin was derived from plasma concentration versus time for RIB.

    Time frame: Pre-dose (0h) on Days 6, 8, 10, and 11, and post-dose (1h,2h,3h,4h,6h,8h,12h) on Day 10 for RIB 150 mg QD; and pre-dose (0h) on Days 4, 8,11 to 18 and post-dose (1h,2h,3h,4h,6h,8h,12h) on Days 11 and 15 for ATV/RTV + RIB.

  4. AUC24avg for 25-O-Desacetyl-RIB

    AUC24avg is AUC(0-24 hour) following dosing on Day 10 for RIB 150 mg QD; AUC24avg is the area under the plasma concentration-time curve in 1 dosing interval (AUC\[TAU\]) divided by the number of days over the sampling duration for ATV/RTV 300/100 mg QD+RIB 150 mg twice weekly, i.e. AUC(TAU)/7

    Time frame: Pre-dose (0h) on Days 6, 8, 10, and 11, and post-dose (1h,2h,3h,4h,6h,8h,12h) on Day 10 for RIB 150 mg QD; and pre-dose (0h) on Days 4, 8,11 to 18 and post-dose (1h,2h,3h,4h,6h,8h,12h) on Days 11 and 15 for ATV/RTV + RIB.

  5. Cmax of 25-O-Desacetylrifabutin (25-O-Desacetyl-RIB)

    Cmax was derived from the plasma concentration versus time for 25-O-Desacetyl-RIB (a metabolite of RIB) and was recorded directly from experimental observations for each treatment period.

    Time frame: Pre-dose (0h) on Days 6, 8, 10, and 11, and post-dose (1h,2h,3h,4h,6h,8h,12h) on Day 10 for RIB 150 mg QD; and pre-dose (0h) on Days 4, 8,11 to 18 and post-dose (1h,2h,3h,4h,6h,8h,12h) on Days 11 and 15 for ATV/RTV + RIB.

  6. Cmin of 25-O-Desacetyl-RIB

    Cmin was derived from plasma concentration versus time for 25-O-Desacetyl-RIB.

    Time frame: Pre-dose (0h) on Days 6, 8, 10, and 11, and post-dose (1h,2h,3h,4h,6h,8h,12h) on Day 10 for RIB 150 mg QD; and pre-dose (0h) on Days 4, 8,11 to 18 and post-dose (1h,2h,3h,4h,6h,8h,12h) on Days 11 and 15 for ATV/RTV + RIB.

  7. Total Area Under the Plasma Concentration-time Curve (AUCtot)

    AUCtot represents the total free RIB plus 25-O-Desacetyl-RIB output. It is calculated as: AUCtot (micromolar\[µM\]\*h) = AUC24avg(RIB)(ng\*h/mL)/847.016 (g/mole) + AUC24avg(25-O-Desacetyl-RIB)(ng\*h/mL)/804.979(g/mole). The 300 mg RIB arm represents an extrapolation from the 150 mg RIB group.

    Time frame: Pre-dose (0h) on Days 6, 8, 10, and 11, and post-dose (1h,2h,3h,4h,6h,8h,12h) on Day 10 for RIB 150 mg QD; and pre-dose (0h) on Days 4, 8,11 to 18 and post-dose (1h,2h,3h,4h,6h,8h,12h) on Days 11 and 15 for ATV/RTV + RIB.

Secondary outcomes

  1. Cmax of ATV

    Cmax was derived from the plasma concentration versus time for ATV and was recorded directly from experimental observations for each treatment period.

    Time frame: Pre-dose (0h) on Days 4, 8, 11 to 18 and post-dose (1h,2h,3h,4h,6h,8h,12h) on Days 11 and 15 for ATV/RTV + RIB.

  2. Cmin of ATV

    Cmin was derived from the plasma concentration versus time for ATV.

    Time frame: Pre-dose (0h) on Days 4, 8, 11 to 18 and post-dose (1h,2h,3h,4h,6h,8h,12h) on Days 11 and 15 for ATV/RTV + RIB.

  3. AUC(TAU) for ATV

    AUC(TAU) was derived from the plasma concentration versus time for ATV, and was calculated by linear and log-linear trapezoidal summations using a mixed log-linear algorithm.

    Time frame: Pre-dose (0h) on Days 4, 8, 11 to 18 and post-dose (1h,2h,3h,4h,6h,8h,12h) on Days 11 and 15 for ATV/RTV + RIB.

  4. Time to Reach Maximum Observed Plasma Concentration (Tmax) of ATV

    Tmax was derived from the plasma concentration versus time for ATV and was recorded directly from experimental observations for each treatment period.

    Time frame: Pre-dose (0h) on Days 4, 8, 11 to 18 and post-dose (1h,2h,3h,4h,6h,8h,12h) on Days 11 and 15 for ATV/RTV + RIB.

  5. Terminal Elimination Half-life (T-half) of ATV

    T-half was obtained directly from the concentration-time data. T-half following doses administered for treatment ATV/RTV 300/100 mg QD+RIB 150 mg twice weekly.

    Time frame: Pre-dose (0h) on Days 4, 8, 11 to 18 and post-dose (1h,2h,3h,4h,6h,8h,12h) on Days 11 and 15 for ATV/RTV + RIB.

  6. Cmax of RTV

    Cmax was derived from the plasma concentration versus time for RTV and was recorded directly from experimental observations for each treatment period.

    Time frame: Pre-dose (0h) on Days 4, 8, 11 to 18 and post-dose (1h,2h,3h,4h,6h,8h,12h) on Days 11 and 15 for ATV/RTV + RIB.

  7. Cmin of RTV

    Cmin was derived from the plasma concentration versus time for RTV.

    Time frame: Pre-dose (0h) on Days 4, 8, 11 to 18 and post-dose (1h,2h,3h,4h,6h,8h,12h) on Days 11 and 15 for ATV/RTV + RIB.

  8. AUC(TAU) for RTV

    AUC(TAU) was derived from the plasma concentration versus time for RTV, and was calculated by linear and log-linear trapezoidal summations using a mixed log-linear algorithm.

    Time frame: Pre-dose (0h) on Days 4, 8, 11 to 18 and post-dose (1h,2h,3h,4h,6h,8h,12h) on Days 11 and 15 for ATV/RTV + RIB.

  9. Tmax of RTV

    Tmax was derived from the plasma concentration versus time for RTV and was recorded directly from experimental observations for each treatment period.

    Time frame: Pre-dose (0h) on Days 4, 8, 11 to 18 and post-dose (1h,2h,3h,4h,6h,8h,12h) on Days 11 and 15 for ATV/RTV + RIB.

  10. T-half of RTV

    T-half was obtained directly from the concentration-time data.

    Time frame: Pre-dose (0h) on Days 4, 8, 11 to 18 and post-dose (1h,2h,3h,4h,6h,8h,12h) on Days 11 and 15 for ATV/RTV + RIB.

  11. Number of Participants Who Died, Experienced Other Serious Adverse Events (SAEs), Experienced Adverse Events (AEs) and Experienced Events Leading to Discontinuation.

    AEs were defined as new, untoward medical occurrences/worsening of pre-existing medical condition, whether drug-related or not. SAEs were defined as any AE that: resulted in death; was life threatening; resulted in a persistent or significant disability/incapacity; resulted in/prolonged an existing in-patient hospitalization; was a congenital anomaly/birth defect; was a cancer; or was an overdose. Discontinuation from the study was due either to an AE or was conducted at the investigator's discretion.

    Time frame: From Day 1 to 30 days after the last dose of study drug.

  12. Number of Participants With Marked Abnormalities (MAs) in Hematology: Hemoglobin, Hematocrit, Platelet Count and Leukocytes

    MAs are laboratory measurements marked as abnormal, per pre-defined study criteria, at any study time point. The following hematology MA definitions specify the criteria for the data presented. Hemoglobin/hematocrit: \<0.85 x pre-treatment (pre-Rx) value. Platelet count: \<0.85 x lower limit of normal (LLN) (or, if pre-Rx value \<LLN, then \<0.85 x pre-Rx value) or \>1.5 x upper limit of normal (ULN). Leukocytes: \<0.9 x LLN or \>1.2 x ULN (or, if pre-Rx value \<LLN, then \<0.85 x pre-Rx or \>ULN. If pre-Rx value \>ULN, then \>1.15 x pre-Rx or \<LLN).

    Time frame: Pre-dose on Day -1 and post-dose on Days 3, 7, 11, 14, 20 and 26 for RIB 150 mg QD; and pre-dose on Day -1 and post-dose on Days 3, 7, 11, 14 and 18 for ATV/RTV 300/100 mg QD + RIB 150 mg twice weekly.

  13. Number of Participants With MAs in Hematology: Neutrophils + Bands (Absolute), Lymphocytes (Absolute), Monocytes (Absolute), Basophils (Absolute) and Eosinophils (Absolute)

    MAs are laboratory measurements marked as abnormal, per pre-defined study criteria, at any study time point. The following hematology MA definitions specify the criteria for the data presented. Neutrophils+bands (absolute): \<=1.50 x 10\^3 cells/microliter (uL). Lymphocytes (absolute): \<0.75 x 10\^3 cells/uL or \>7.50 x 10\^3 cells/uL. Monocytes (absolute): \>2.00 x 10\^3 cells/uL. Basophils (absolute): \>0.40 x 10\^3 cells/uL. Eosinophils (absolute): \>0.75 x 10\^3 cells/uL.

    Time frame: Pre-dose on Day -1 and post-dose on Days 3, 7, 11, 14, 20 and 26 for RIB 150 mg QD; and pre-dose on Day -1 and post-dose on Days 3, 7, 11, 14 and 18 for ATV/RTV 300/100 mg QD + RIB 150 mg twice weekly.

  14. Number of Participants With MAs in Serum Chemistry: Alkaline Phosphatase (ALP),Aspartate Aminotransferase (AST),Alanine Aminotransferase (ALT),Bilirubin (Total),Bilirubin (Direct),Blood Urea Nitrogen (BUN),Creatinine,Sodium (Serum),Potassium (Serum)

    MAs=laboratory measurements marked as abnormal, per pre-defined study criteria, at any study time point. The following serum chemistry MA definitions specify MA criteria. ALP, AST, ALT:\>1.25xULN (if pre-Rx \>ULN, then \>1.25xpre-Rx). Bilirubin (total), bilirubin (direct), BUN:\>1.1xULN (if pre-Rx \>ULN, then \>1.25xpre-Rx). Creatinine:\>1.33xpre-Rx. Sodium (serum):\<0.95xLLN or \>1.05xULN (if pre-Rx \<LLN, then \<0.95xpre-Rx or \>ULN. If pre-Rx \>ULN, then \>1.05xpre-Rx or \<LLN). Potassium (serum):\<0.9xLLN or \>1.1xULN (if pre-Rx \<LLN, then \<0.9xpre-Rx or \>ULN. If pre-Rx \>ULN, then \>1.1xpre-Rx or \<LLN).

    Time frame: Pre-dose on Day -1 and post-dose on Days 3, 7, 11, 14, 20 and 26 for RIB 150 mg QD; and pre-dose on Day -1 and post-dose on Days 3, 7, 11, 14 and 18 for ATV/RTV 300/100 mg QD + RIB 150 mg twice weekly.

  15. Number of Participants With MAs in Serum Chemistry: Chloride (Serum), Calcium (Total), Protein (Total), Bicarbonate, Phosphorous (Inorganic)

    MAs=laboratory measurements marked as abnormal, per pre-defined study criteria, at any study time point. The following serum chemistry MA definitions specify MA criteria. Chloride (serum), calcium (total), protein (total):\<0.9xLLN or \>1.1xULN (if pre-Rx \<LLN, then \<0.9xpre-Rx or \>ULN. If pre-Rx \>ULN, then \>1.1xpre-Rx or \<LLN). Bicarbonate:\<0.8xLLN or \>1.2xULN (if pre-Rx value \<LLN, then \<0.8xpre-Rx value or \>ULN. If pre-Rx \>ULN, then \>1.2xpre-Rx value or \<ULN). Phosphorous (inorganic):\<0.85xLLN or \>1.25xULN (if pre-Rx \<ULN, then \<0.85xpre-Rx or \<ULN. If pre-Rx \>ULN, then \>1.25x re-Rx or \<LLN).

    Time frame: Pre-dose on Day -1 and post-dose on Days 3, 7, 11, 14, 20 and 26 for RIB 150 mg QD; and pre-dose on Day -1 and post-dose on Days 3, 7, 11, 14 and 18 for ATV/RTV 300/100 mg QD + RIB 150 mg twice weekly.

  16. Number of Participants With MAs in Serum Chemistry: Glucose (Fasting Serum), Albumin, Creatine Kinase, Uric Acid, Lactate Dehydrogenase (LDH)

    MAs=laboratory measurements marked as abnormal, per pre-defined study criteria, at any study time point. The following serum chemistry MA definitions specify MA criteria. Glucose (fasting serum): \<0.8 x LLN or \>1.5 ULN (if pre-Rx \<LLN, then \<0.8 x pre-Rx or \>ULN. If pre-Rx \>ULN, then \>2.0 x pre-Rx or \<LLN. Albumin: \<0.9 x LLN (if pre-Rx \<LLN, then \<0.9 x pre-Rx). Creatine kinase: \>1.5 x ULN (if pre-Rx \>ULN, then \>1.5 x pre-Rx). Uric acid: \>1.2 x ULN (if pre-Rx \>ULN, then \>1.25 x pre-Rx). LDH: \>1.25 x ULN (if pre-Rx \>ULN, then \>1.5 x pre-Rx).

    Time frame: Pre-dose on Day -1 and post-dose on Days 3, 7, 11, 14, 20 and 26 for RIB 150 mg QD; and pre-dose on Day -1 and post-dose on Days 3, 7, 11, 14 and 18 for ATV/RTV 300/100 mg QD + RIB 150 mg twice weekly.

  17. Number of Participants With MAs in Urinalysis

    MAs are laboratory measurements marked as abnormal, per pre-defined study criteria, at any study time point. The following definitions specify the criteria for MAs. Protein, glucose and blood: \>=2+ (or, if pre-treatment value \>=1+, then \>= 2 x pre-treatment value).

    Time frame: Pre-dose on Day -1, Day 7 and discharge.

  18. Number of Participants With Identified Electrocardiogram (ECG) Abnormalities

    ECG abnormalities were defined as findings that are clinically meaningful as judged by the investigator. A 12-lead ECG was recorded at least 5 minutes after the participant had been lying down and all ECG recordings were evaluated by the investigator. Abnormalities, if present at any study time point, were listed.

    Time frame: Pre-dose on Day -1 and study discharge.

  19. Number of Participants With Clinically Significant Vital Signs or Physical Examination Findings

    Vital signs assessments and physical examination were conducted throughout the study. Vital signs assessments included body temperature, respiratory rate, blood pressure (systolic and diastolic), and heart rate. Physical examination included a neurological examination (if ocular signs or symptoms occurred, a reflex to slit lamp exam was performed by an ophthalmologist). The investigator used his/her clinical judgment to decide whether or not abnormalities in vital signs or physical examination were clinically meaningful.

    Time frame: Vital signs:screening, prior to dosing on Day 1, Day 7, study discharge. Physical examination:screening, Day -1, Day 7, study discharge

07

Results

Posted Jan 5, 2011

Participant flow

Participant flow — Overall Study
MilestoneRIB 150 mg Once Daily (QD)ATV/RTV 300/100 mg QD+RIB 150 mg Twice Weekly
Started1518
Completed145
Not completed113
Withdrew: Adverse event19
Withdrew: Investigator discretion04

Outcome measures

PrimaryAverage Area Under the Plasma Concentration-time Curve for 24 Hours (AUC24avg) for Rifabutin (RIB)

AUC24avg is AUC(0-24 hour) following dosing on Day 10 for RIB 150mg once daily (QD); AUC24avg is the area under the plasma concentration-time curve in 1 dosing interval (AUC\[TAU\]) divided by the number of days over the sampling duration for ATV/RTV 300/100 mg QD+RIB 150 mg twice weekly, i.e. AUC(TAU)/7.

Time frame:
Pre-dose (0 hours [h]) on Days 6, 8, 10, and 11, and post-dose (1h,2h,3h,4h,6h,8h,12h) on Day 10 for RIB 150 mg QD; and pre-dose (0h) on Days 4, 8,11 to 18 and post-dose (1h,2h,3h,4h,6h,8h,12h) on Days 11 and 15 for ATV/RTV + RIB.
Reported as:
Geometric mean · nanograms*hour /milliliters (ng*h/mL)
Average Area Under the Plasma Concentration-time Curve for 24 Hours (AUC24avg) for Rifabutin (RIB)
nanograms*hour /milliliters (ng*h/mL)RIB 150 mg Once Daily (QD)ATV/RTV 300/100 mg QD+RIB 150 mg Twice Weekly
Average Area Under the Plasma Concentration-time Curve for 24 Hours (AUC24avg) for Rifabutin (RIB)1565 ± 528.492311 ± 507.99
Statistical analysis
  • RIB 150 mg Once Daily (QD) vs ATV/RTV 300/100 mg QD+RIB 150 mg Twice Weekly · ANOVA · Point estimate: 1.477 · 90% CI 1.188 to 1.835Point estimates and 90% confidence intervals of treatment differences on the log scale were exponentiated to obtain estimates on the original scale.
PrimaryMaximum Plasma Concentration (Cmax) of RIB

Cmax was derived from plasma concentration versus time for RIB and was recorded directly from experimental observations for each treatment period.

Time frame:
Pre-dose (0h) on Days 6, 8, 10, and 11, and post-dose (1h,2h,3h,4h,6h,8h,12h) on Day 10 for RIB 150 mg QD; and pre-dose (0h) on Days 4, 8,11 to 18 and post-dose (1h,2h,3h,4h,6h,8h,12h) on Days 11 and 15 for ATV/RTV + RIB.
Reported as:
Geometric mean · ng/mL
Maximum Plasma Concentration (Cmax) of RIB
ng/mLRIB 150 mg Once Daily (QD)ATV/RTV 300/100 mg QD+RIB 150 mg Twice Weekly
Maximum Plasma Concentration (Cmax) of RIB159.0 ± 50.52395.6 ± 54.32
Statistical analysis
  • RIB 150 mg Once Daily (QD) vs ATV/RTV 300/100 mg QD+RIB 150 mg Twice Weekly · ANOVA · Point estimate: 2.489 · 90% CI 2.025 to 3.060Point estimates and 90% confidence intervals of treatment differences on the log scale were exponentiated to obtain estimates on the original scale.
PrimaryMinimum Plasma Concentration (Cmin) of RIB

Cmin was derived from plasma concentration versus time for RIB.

Time frame:
Pre-dose (0h) on Days 6, 8, 10, and 11, and post-dose (1h,2h,3h,4h,6h,8h,12h) on Day 10 for RIB 150 mg QD; and pre-dose (0h) on Days 4, 8,11 to 18 and post-dose (1h,2h,3h,4h,6h,8h,12h) on Days 11 and 15 for ATV/RTV + RIB.
Reported as:
Geometric mean · ng/mL
Minimum Plasma Concentration (Cmin) of RIB
ng/mLRIB 150 mg Once Daily (QD)ATV/RTV 300/100 mg QD+RIB 150 mg Twice Weekly
Minimum Plasma Concentration (Cmin) of RIB28.89 ± 14.0840.49 ± 11.27
Statistical analysis
  • RIB 150 mg Once Daily (QD) vs ATV/RTV 300/100 mg QD+RIB 150 mg Twice Weekly · ANOVA · Point estimate: 1.402 · 90% CI 1.052 to 1.867Point estimates and 90% confidence intervals of treatment differences on the log scale were exponentiated to obtain estimates on the original scale.
SecondaryCmax of ATV

Cmax was derived from the plasma concentration versus time for ATV and was recorded directly from experimental observations for each treatment period.

Time frame:
Pre-dose (0h) on Days 4, 8, 11 to 18 and post-dose (1h,2h,3h,4h,6h,8h,12h) on Days 11 and 15 for ATV/RTV + RIB.
Reported as:
Geometric mean · ng/mL
Cmax of ATV
ng/mLATV/RTV 300/100 mg QD+RIB 150 mg Twice Weekly
Cmax of ATV5633 ± 940.84
Statistical analysis
  • ATV/RTV 300/100 mg QD+RIB 150 mg Twice Weekly · ANOVA · Point estimate: 0.947 · 90% CI 0.817 to 1.098
SecondaryCmin of ATV

Cmin was derived from the plasma concentration versus time for ATV.

Time frame:
Pre-dose (0h) on Days 4, 8, 11 to 18 and post-dose (1h,2h,3h,4h,6h,8h,12h) on Days 11 and 15 for ATV/RTV + RIB.
Reported as:
Geometric mean · ng/mL
Cmin of ATV
ng/mLATV/RTV 300/100 mg QD+RIB 150 mg Twice Weekly
Cmin of ATV920.69 ± 497.07
Statistical analysis
  • ATV/RTV 300/100 mg QD+RIB 150 mg Twice Weekly · ANOVA · p = 0.0963 · Point estimate: 0.7450 · 90% CI 0.5569 to 0.9967
SecondaryAUC(TAU) for ATV

AUC(TAU) was derived from the plasma concentration versus time for ATV, and was calculated by linear and log-linear trapezoidal summations using a mixed log-linear algorithm.

Time frame:
Pre-dose (0h) on Days 4, 8, 11 to 18 and post-dose (1h,2h,3h,4h,6h,8h,12h) on Days 11 and 15 for ATV/RTV + RIB.
Reported as:
Geometric mean · ng*h/mL
AUC(TAU) for ATV
ng*h/mLATV/RTV 300/100 mg QD+RIB 150 mg Twice Weekly
AUC(TAU) for ATV51795 ± 12680.65
Statistical analysis
  • ATV/RTV 300/100 mg QD+RIB 150 mg Twice Weekly · ANOVA · Point estimate: 0.857 · 90% CI 0.723 to 1.015
SecondaryTime to Reach Maximum Observed Plasma Concentration (Tmax) of ATV

Tmax was derived from the plasma concentration versus time for ATV and was recorded directly from experimental observations for each treatment period.

Time frame:
Pre-dose (0h) on Days 4, 8, 11 to 18 and post-dose (1h,2h,3h,4h,6h,8h,12h) on Days 11 and 15 for ATV/RTV + RIB.
Reported as:
Median · Hour
Time to Reach Maximum Observed Plasma Concentration (Tmax) of ATV
HourATV/RTV 300/100 mg QD+RIB 150 mg Twice Weekly
Time to Reach Maximum Observed Plasma Concentration (Tmax) of ATV2.00 ± 0.88
SecondaryTerminal Elimination Half-life (T-half) of ATV

T-half was obtained directly from the concentration-time data. T-half following doses administered for treatment ATV/RTV 300/100 mg QD+RIB 150 mg twice weekly.

Time frame:
Pre-dose (0h) on Days 4, 8, 11 to 18 and post-dose (1h,2h,3h,4h,6h,8h,12h) on Days 11 and 15 for ATV/RTV + RIB.
Reported as:
Mean · Hour
Terminal Elimination Half-life (T-half) of ATV
HourATV/RTV 300/100 mg QD+RIB 150 mg Twice Weekly
Terminal Elimination Half-life (T-half) of ATV11.89 ± 3.65
SecondaryCmax of RTV

Cmax was derived from the plasma concentration versus time for RTV and was recorded directly from experimental observations for each treatment period.

Time frame:
Pre-dose (0h) on Days 4, 8, 11 to 18 and post-dose (1h,2h,3h,4h,6h,8h,12h) on Days 11 and 15 for ATV/RTV + RIB.
Reported as:
Geometric mean · ng/mL
Cmax of RTV
ng/mLATV/RTV 300/100 mg QD+RIB 150 mg Twice Weekly
Cmax of RTV1466 ± 467.23
Statistical analysis
  • ATV/RTV 300/100 mg QD+RIB 150 mg Twice Weekly · ANOVA · Point estimate: 0.660 · 90% CI 0.538 to 0.809
SecondaryCmin of RTV

Cmin was derived from the plasma concentration versus time for RTV.

Time frame:
Pre-dose (0h) on Days 4, 8, 11 to 18 and post-dose (1h,2h,3h,4h,6h,8h,12h) on Days 11 and 15 for ATV/RTV + RIB.
Reported as:
Geometric mean · ng/mL
Cmin of RTV
ng/mLATV/RTV 300/100 mg QD+RIB 150 mg Twice Weekly
Cmin of RTV40.54 ± 34.78
Statistical analysis
  • ATV/RTV 300/100 mg QD+RIB 150 mg Twice Weekly · ANOVA · Point estimate: 0.651 · 90% CI 0.430 to 0.986
SecondaryAUC(TAU) for RTV

AUC(TAU) was derived from the plasma concentration versus time for RTV, and was calculated by linear and log-linear trapezoidal summations using a mixed log-linear algorithm.

Time frame:
Pre-dose (0h) on Days 4, 8, 11 to 18 and post-dose (1h,2h,3h,4h,6h,8h,12h) on Days 11 and 15 for ATV/RTV + RIB.
Reported as:
Geometric mean · ng*h/mL
AUC(TAU) for RTV
ng*h/mLATV/RTV 300/100 mg QD+RIB 150 mg Twice Weekly
AUC(TAU) for RTV8699 ± 3002.89
Statistical analysis
  • ATV/RTV 300/100 mg QD+RIB 150 mg Twice Weekly · ANOVA · Point estimate: 0.696 · 90% CI 0.563 to 0.862
SecondaryTmax of RTV

Tmax was derived from the plasma concentration versus time for RTV and was recorded directly from experimental observations for each treatment period.

Time frame:
Pre-dose (0h) on Days 4, 8, 11 to 18 and post-dose (1h,2h,3h,4h,6h,8h,12h) on Days 11 and 15 for ATV/RTV + RIB.
Reported as:
Median · Hour
Tmax of RTV
HourATV/RTV 300/100 mg QD+RIB 150 mg Twice Weekly
Tmax of RTV4.00 ± 0.87
SecondaryT-half of RTV

T-half was obtained directly from the concentration-time data.

Time frame:
Pre-dose (0h) on Days 4, 8, 11 to 18 and post-dose (1h,2h,3h,4h,6h,8h,12h) on Days 11 and 15 for ATV/RTV + RIB.
Reported as:
Mean · Hour
T-half of RTV
HourATV/RTV 300/100 mg QD+RIB 150 mg Twice Weekly
T-half of RTV4.45 ± 0.65
SecondaryNumber of Participants Who Died, Experienced Other Serious Adverse Events (SAEs), Experienced Adverse Events (AEs) and Experienced Events Leading to Discontinuation.

AEs were defined as new, untoward medical occurrences/worsening of pre-existing medical condition, whether drug-related or not. SAEs were defined as any AE that: resulted in death; was life threatening; resulted in a persistent or significant disability/incapacity; resulted in/prolonged an existing in-patient hospitalization; was a congenital anomaly/birth defect; was a cancer; or was an overdose. Discontinuation from the study was due either to an AE or was conducted at the investigator's discretion.

Time frame:
From Day 1 to 30 days after the last dose of study drug.
Reported as:
Number · Participants
Number of Participants Who Died, Experienced Other Serious Adverse Events (SAEs), Experienced Adverse Events (AEs) and Experienced Events Leading to Discontinuation.
ParticipantsRIB 150 mg Once Daily (QD)ATV/RTV 300/100 mg QD+RIB 150 mg Twice Weekly
Deaths00
Other SAEs02
AEs513
AE leading to discontinuation19
Discontinuation due to investigator discretion04
SecondaryNumber of Participants With Marked Abnormalities (MAs) in Hematology: Hemoglobin, Hematocrit, Platelet Count and Leukocytes

MAs are laboratory measurements marked as abnormal, per pre-defined study criteria, at any study time point. The following hematology MA definitions specify the criteria for the data presented. Hemoglobin/hematocrit: \<0.85 x pre-treatment (pre-Rx) value. Platelet count: \<0.85 x lower limit of normal (LLN) (or, if pre-Rx value \<LLN, then \<0.85 x pre-Rx value) or \>1.5 x upper limit of normal (ULN). Leukocytes: \<0.9 x LLN or \>1.2 x ULN (or, if pre-Rx value \<LLN, then \<0.85 x pre-Rx or \>ULN. If pre-Rx value \>ULN, then \>1.15 x pre-Rx or \<LLN).

Time frame:
Pre-dose on Day -1 and post-dose on Days 3, 7, 11, 14, 20 and 26 for RIB 150 mg QD; and pre-dose on Day -1 and post-dose on Days 3, 7, 11, 14 and 18 for ATV/RTV 300/100 mg QD + RIB 150 mg twice weekly.
Reported as:
Number · Participants
Number of Participants With Marked Abnormalities (MAs) in Hematology: Hemoglobin, Hematocrit, Platelet Count and Leukocytes
ParticipantsRIB 150 mg Once Daily (QD)ATV/RTV 300/100 mg QD+RIB 150 mg Twice Weekly
Hemoglobin01
Hematocrit01
Platelet count00
Leukocytes17
SecondaryNumber of Participants With MAs in Hematology: Neutrophils + Bands (Absolute), Lymphocytes (Absolute), Monocytes (Absolute), Basophils (Absolute) and Eosinophils (Absolute)

MAs are laboratory measurements marked as abnormal, per pre-defined study criteria, at any study time point. The following hematology MA definitions specify the criteria for the data presented. Neutrophils+bands (absolute): \<=1.50 x 10\^3 cells/microliter (uL). Lymphocytes (absolute): \<0.75 x 10\^3 cells/uL or \>7.50 x 10\^3 cells/uL. Monocytes (absolute): \>2.00 x 10\^3 cells/uL. Basophils (absolute): \>0.40 x 10\^3 cells/uL. Eosinophils (absolute): \>0.75 x 10\^3 cells/uL.

Time frame:
Pre-dose on Day -1 and post-dose on Days 3, 7, 11, 14, 20 and 26 for RIB 150 mg QD; and pre-dose on Day -1 and post-dose on Days 3, 7, 11, 14 and 18 for ATV/RTV 300/100 mg QD + RIB 150 mg twice weekly.
Reported as:
Number · Participants
Number of Participants With MAs in Hematology: Neutrophils + Bands (Absolute), Lymphocytes (Absolute), Monocytes (Absolute), Basophils (Absolute) and Eosinophils (Absolute)
ParticipantsRIB 150 mg Once Daily (QD)ATV/RTV 300/100 mg QD+RIB 150 mg Twice Weekly
Neutrophils+bands (absolute)110
Lymphocytes (absolute)15
Monocytes (absolute)00
Basophils (absolute)00
Eosinophils (absolute)00
PrimaryAUC24avg for 25-O-Desacetyl-RIB

AUC24avg is AUC(0-24 hour) following dosing on Day 10 for RIB 150 mg QD; AUC24avg is the area under the plasma concentration-time curve in 1 dosing interval (AUC\[TAU\]) divided by the number of days over the sampling duration for ATV/RTV 300/100 mg QD+RIB 150 mg twice weekly, i.e. AUC(TAU)/7

Time frame:
Pre-dose (0h) on Days 6, 8, 10, and 11, and post-dose (1h,2h,3h,4h,6h,8h,12h) on Day 10 for RIB 150 mg QD; and pre-dose (0h) on Days 4, 8,11 to 18 and post-dose (1h,2h,3h,4h,6h,8h,12h) on Days 11 and 15 for ATV/RTV + RIB.
Reported as:
Geometric mean · ng*h/mL
AUC24avg for 25-O-Desacetyl-RIB
ng*h/mLRIB 150 mg Once Daily (QD)ATV/RTV 300/100 mg QD+RIB 150 mg Twice Weekly
AUC24avg for 25-O-Desacetyl-RIB117.7 ± 53.481283 ± 260.71
Statistical analysis
  • RIB 150 mg Once Daily (QD) vs ATV/RTV 300/100 mg QD+RIB 150 mg Twice Weekly · ANOVA · Point estimate: 10.902 · 90% CI 8.135 to 14.610
PrimaryCmax of 25-O-Desacetylrifabutin (25-O-Desacetyl-RIB)

Cmax was derived from the plasma concentration versus time for 25-O-Desacetyl-RIB (a metabolite of RIB) and was recorded directly from experimental observations for each treatment period.

Time frame:
Pre-dose (0h) on Days 6, 8, 10, and 11, and post-dose (1h,2h,3h,4h,6h,8h,12h) on Day 10 for RIB 150 mg QD; and pre-dose (0h) on Days 4, 8,11 to 18 and post-dose (1h,2h,3h,4h,6h,8h,12h) on Days 11 and 15 for ATV/RTV + RIB.
Reported as:
Geometric mean · ng/mL
Cmax of 25-O-Desacetylrifabutin (25-O-Desacetyl-RIB)
ng/mLRIB 150 mg Once Daily (QD)ATV/RTV 300/100 mg QD+RIB 150 mg Twice Weekly
Cmax of 25-O-Desacetylrifabutin (25-O-Desacetyl-RIB)13.44 ± 4.50104.36 ± 21.31
Statistical analysis
  • RIB 150 mg Once Daily (QD) vs ATV/RTV 300/100 mg QD+RIB 150 mg Twice Weekly · ANCOVA · Point estimate: 7.766 · 90% CI 6.133 to 9.833
PrimaryCmin of 25-O-Desacetyl-RIB

Cmin was derived from plasma concentration versus time for 25-O-Desacetyl-RIB.

Time frame:
Pre-dose (0h) on Days 6, 8, 10, and 11, and post-dose (1h,2h,3h,4h,6h,8h,12h) on Day 10 for RIB 150 mg QD; and pre-dose (0h) on Days 4, 8,11 to 18 and post-dose (1h,2h,3h,4h,6h,8h,12h) on Days 11 and 15 for ATV/RTV + RIB.
Reported as:
Geometric mean · ng/mL
Cmin of 25-O-Desacetyl-RIB
ng/mLRIB 150 mg Once Daily (QD)ATV/RTV 300/100 mg QD+RIB 150 mg Twice Weekly
Cmin of 25-O-Desacetyl-RIB2.79 ± 1.4031.97 ± 10.60
Statistical analysis
  • RIB 150 mg Once Daily (QD) vs ATV/RTV 300/100 mg QD+RIB 150 mg Twice Weekly · ANOVA · Point estimate: 11.451 · 90% CI 8.147 to 16.095
PrimaryTotal Area Under the Plasma Concentration-time Curve (AUCtot)

AUCtot represents the total free RIB plus 25-O-Desacetyl-RIB output. It is calculated as: AUCtot (micromolar\[µM\]\*h) = AUC24avg(RIB)(ng\*h/mL)/847.016 (g/mole) + AUC24avg(25-O-Desacetyl-RIB)(ng\*h/mL)/804.979(g/mole). The 300 mg RIB arm represents an extrapolation from the 150 mg RIB group.

Time frame:
Pre-dose (0h) on Days 6, 8, 10, and 11, and post-dose (1h,2h,3h,4h,6h,8h,12h) on Day 10 for RIB 150 mg QD; and pre-dose (0h) on Days 4, 8,11 to 18 and post-dose (1h,2h,3h,4h,6h,8h,12h) on Days 11 and 15 for ATV/RTV + RIB.
Reported as:
Geometric mean · µM*h
Total Area Under the Plasma Concentration-time Curve (AUCtot)
µM*hRIB 150 mg Once Daily (QD)ATV/RTV 300/100 mg QD+RIB 150 mg Twice WeeklyRIB 300 mg QD
Total Area Under the Plasma Concentration-time Curve (AUCtot)2.00 ± 0.684.38 ± 0.57—
Statistical analysis
  • RIB 150 mg Once Daily (QD) vs ATV/RTV 300/100 mg QD+RIB 150 mg Twice Weekly · ANOVA · Point estimate: 2.190 · 90% CI 1.783 to 2.691Point estimates and 90% confidence intervals of treatment differences on the log scale were exponentiated to obtain estimates on the original scale.
SecondaryNumber of Participants With MAs in Serum Chemistry: Alkaline Phosphatase (ALP),Aspartate Aminotransferase (AST),Alanine Aminotransferase (ALT),Bilirubin (Total),Bilirubin (Direct),Blood Urea Nitrogen (BUN),Creatinine,Sodium (Serum),Potassium (Serum)

MAs=laboratory measurements marked as abnormal, per pre-defined study criteria, at any study time point. The following serum chemistry MA definitions specify MA criteria. ALP, AST, ALT:\>1.25xULN (if pre-Rx \>ULN, then \>1.25xpre-Rx). Bilirubin (total), bilirubin (direct), BUN:\>1.1xULN (if pre-Rx \>ULN, then \>1.25xpre-Rx). Creatinine:\>1.33xpre-Rx. Sodium (serum):\<0.95xLLN or \>1.05xULN (if pre-Rx \<LLN, then \<0.95xpre-Rx or \>ULN. If pre-Rx \>ULN, then \>1.05xpre-Rx or \<LLN). Potassium (serum):\<0.9xLLN or \>1.1xULN (if pre-Rx \<LLN, then \<0.9xpre-Rx or \>ULN. If pre-Rx \>ULN, then \>1.1xpre-Rx or \<LLN).

Time frame:
Pre-dose on Day -1 and post-dose on Days 3, 7, 11, 14, 20 and 26 for RIB 150 mg QD; and pre-dose on Day -1 and post-dose on Days 3, 7, 11, 14 and 18 for ATV/RTV 300/100 mg QD + RIB 150 mg twice weekly.
Reported as:
Number · Participants
Number of Participants With MAs in Serum Chemistry: Alkaline Phosphatase (ALP),Aspartate Aminotransferase (AST),Alanine Aminotransferase (ALT),Bilirubin (Total),Bilirubin (Direct),Blood Urea Nitrogen (BUN),Creatinine,Sodium (Serum),Potassium (Serum)
ParticipantsRIB 150 mg Once Daily (QD)ATV/RTV 300/100 mg QD+RIB 150 mg Twice Weekly
ALP00
AST00
ALT00
Bilirubin (total)017
Bilirubin (direct)016
BUN00
Creatinine01
Sodium (serum)00
Potassium (serum)00
SecondaryNumber of Participants With MAs in Serum Chemistry: Chloride (Serum), Calcium (Total), Protein (Total), Bicarbonate, Phosphorous (Inorganic)

MAs=laboratory measurements marked as abnormal, per pre-defined study criteria, at any study time point. The following serum chemistry MA definitions specify MA criteria. Chloride (serum), calcium (total), protein (total):\<0.9xLLN or \>1.1xULN (if pre-Rx \<LLN, then \<0.9xpre-Rx or \>ULN. If pre-Rx \>ULN, then \>1.1xpre-Rx or \<LLN). Bicarbonate:\<0.8xLLN or \>1.2xULN (if pre-Rx value \<LLN, then \<0.8xpre-Rx value or \>ULN. If pre-Rx \>ULN, then \>1.2xpre-Rx value or \<ULN). Phosphorous (inorganic):\<0.85xLLN or \>1.25xULN (if pre-Rx \<ULN, then \<0.85xpre-Rx or \<ULN. If pre-Rx \>ULN, then \>1.25x re-Rx or \<LLN).

Time frame:
Pre-dose on Day -1 and post-dose on Days 3, 7, 11, 14, 20 and 26 for RIB 150 mg QD; and pre-dose on Day -1 and post-dose on Days 3, 7, 11, 14 and 18 for ATV/RTV 300/100 mg QD + RIB 150 mg twice weekly.
Reported as:
Number · Participants
Number of Participants With MAs in Serum Chemistry: Chloride (Serum), Calcium (Total), Protein (Total), Bicarbonate, Phosphorous (Inorganic)
ParticipantsRIB 150 mg Once Daily (QD)ATV/RTV 300/100 mg QD+RIB 150 mg Twice Weekly
Chloride (serum)00
Calcium (total)00
Protein (total)00
Bicarbonate00
Phosphorous (inorganic)00
SecondaryNumber of Participants With MAs in Serum Chemistry: Glucose (Fasting Serum), Albumin, Creatine Kinase, Uric Acid, Lactate Dehydrogenase (LDH)

MAs=laboratory measurements marked as abnormal, per pre-defined study criteria, at any study time point. The following serum chemistry MA definitions specify MA criteria. Glucose (fasting serum): \<0.8 x LLN or \>1.5 ULN (if pre-Rx \<LLN, then \<0.8 x pre-Rx or \>ULN. If pre-Rx \>ULN, then \>2.0 x pre-Rx or \<LLN. Albumin: \<0.9 x LLN (if pre-Rx \<LLN, then \<0.9 x pre-Rx). Creatine kinase: \>1.5 x ULN (if pre-Rx \>ULN, then \>1.5 x pre-Rx). Uric acid: \>1.2 x ULN (if pre-Rx \>ULN, then \>1.25 x pre-Rx). LDH: \>1.25 x ULN (if pre-Rx \>ULN, then \>1.5 x pre-Rx).

Time frame:
Pre-dose on Day -1 and post-dose on Days 3, 7, 11, 14, 20 and 26 for RIB 150 mg QD; and pre-dose on Day -1 and post-dose on Days 3, 7, 11, 14 and 18 for ATV/RTV 300/100 mg QD + RIB 150 mg twice weekly.
Reported as:
Number · Participants
Number of Participants With MAs in Serum Chemistry: Glucose (Fasting Serum), Albumin, Creatine Kinase, Uric Acid, Lactate Dehydrogenase (LDH)
ParticipantsRIB 150 mg Once Daily (QD)ATV/RTV 300/100 mg QD+RIB 150 mg Twice Weekly
Glucose (Fasting Serum)00
Albumin00
Creatine Kinase00
Uric Acid00
LDH00
SecondaryNumber of Participants With MAs in Urinalysis

MAs are laboratory measurements marked as abnormal, per pre-defined study criteria, at any study time point. The following definitions specify the criteria for MAs. Protein, glucose and blood: \>=2+ (or, if pre-treatment value \>=1+, then \>= 2 x pre-treatment value).

Time frame:
Pre-dose on Day -1, Day 7 and discharge.
Reported as:
Number · Participants
Number of Participants With MAs in Urinalysis
ParticipantsRIB 150 mg Once Daily (QD)ATV/RTV 300/100 mg QD+RIB 150 mg Twice Weekly
Protein01
Glucose00
Blood01
SecondaryNumber of Participants With Identified Electrocardiogram (ECG) Abnormalities

ECG abnormalities were defined as findings that are clinically meaningful as judged by the investigator. A 12-lead ECG was recorded at least 5 minutes after the participant had been lying down and all ECG recordings were evaluated by the investigator. Abnormalities, if present at any study time point, were listed.

Time frame:
Pre-dose on Day -1 and study discharge.
Reported as:
Number · Participants
Number of Participants With Identified Electrocardiogram (ECG) Abnormalities
ParticipantsRIB 150 mg Once Daily (QD)ATV/RTV 300/100 mg QD+RIB 150 mg Twice Weekly
Number of Participants With Identified Electrocardiogram (ECG) Abnormalities03
SecondaryNumber of Participants With Clinically Significant Vital Signs or Physical Examination Findings

Vital signs assessments and physical examination were conducted throughout the study. Vital signs assessments included body temperature, respiratory rate, blood pressure (systolic and diastolic), and heart rate. Physical examination included a neurological examination (if ocular signs or symptoms occurred, a reflex to slit lamp exam was performed by an ophthalmologist). The investigator used his/her clinical judgment to decide whether or not abnormalities in vital signs or physical examination were clinically meaningful.

Time frame:
Vital signs:screening, prior to dosing on Day 1, Day 7, study discharge. Physical examination:screening, Day -1, Day 7, study discharge
Reported as:
Number · Participants
Number of Participants With Clinically Significant Vital Signs or Physical Examination Findings
ParticipantsRIB 150 mg Once Daily (QD)ATV/RTV 300/100 mg QD+RIB 150 mg Twice Weekly
Number of Participants With Clinically Significant Vital Signs or Physical Examination Findings00

Adverse events

Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
ATV/RTV 300/100mg+RIB 150mg—2/18 (11.1%)13/18 (72.2%)
RIB 150mg—0/15 (0%)5/15 (33.3%)
Most frequent serious events
Most frequent serious events
EventATV/RTV 300/100mg+RIB 150mgRIB 150mg
NEUTROPHIL COUNT DECREASEDInvestigations2/180/15
Most frequent other events
Showing 10 of 43
Most frequent other events
EventATV/RTV 300/100mg+RIB 150mgRIB 150mg
PYREXIAGeneral disorders6/181/15
NEUTROPHIL COUNT DECREASEDInvestigations5/181/15
DIARRHOEAGastrointestinal disorders4/180/15
PAINGeneral disorders3/181/15
JAUNDICEHepatobiliary disorders3/180/15
DIZZINESSNervous system disorders3/180/15
HEADACHENervous system disorders3/182/15
PAIN IN JAWMusculoskeletal and connective tissue disorders0/182/15
RASHSkin and subcutaneous tissue disorders1/182/15
ABDOMINAL PAINGastrointestinal disorders2/180/15

Baseline characteristics

Age Continuous
Age Continuous(years)RIB 150 mg Once Daily (QD)ATV/RTV 300/100 mg QD+RIB 150 mg Twice WeeklyTotal
Mean36 ± 537 ± 936 ± 7
Age, Customized
Age, Customized(participants)RIB 150 mg Once Daily (QD)ATV/RTV 300/100 mg QD+RIB 150 mg Twice WeeklyTotal
<65 years151833
>=65 years000
Sex: Female, Male
Sex: Female, Male(Participants)RIB 150 mg Once Daily (QD)ATV/RTV 300/100 mg QD+RIB 150 mg Twice WeeklyTotal
Female246
Male131427
Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)RIB 150 mg Once Daily (QD)ATV/RTV 300/100 mg QD+RIB 150 mg Twice WeeklyTotal
Hispanic or Latino549
Not Hispanic or Latino101424
Unknown or Not Reported000
Race/Ethnicity, Customized
Race/Ethnicity, Customized(participants)RIB 150 mg Once Daily (QD)ATV/RTV 300/100 mg QD+RIB 150 mg Twice WeeklyTotal
Caucasian9514
Black or African American31215
Asian202
Other Race112
Body Mass Index (BMI)
Body Mass Index (BMI)(kg/m^2)RIB 150 mg Once Daily (QD)ATV/RTV 300/100 mg QD+RIB 150 mg Twice WeeklyTotal
Mean26.1 ± 3.226.6 ± 3.526.4 ± 3.3
Height Continuous
Height Continuous(cm)RIB 150 mg Once Daily (QD)ATV/RTV 300/100 mg QD+RIB 150 mg Twice WeeklyTotal
Mean173.7 ± 7.3174.4 ± 10.0174.1 ± 8.8
Weight Continuous
Weight Continuous(kg)RIB 150 mg Once Daily (QD)ATV/RTV 300/100 mg QD+RIB 150 mg Twice WeeklyTotal
Mean79.1 ± 12.081.3 ± 14.980.3 ± 13.5
08

Study locations

1 site
  • Bristol-Myers Squibb Clinical Pharmacology Unit
    Hamilton, New Jersey 08690, United States
09

References and documents

Publications

  • Zhang J, Zhu L, Stonier M, Coumbis J, Xu X, Wu Y, Arikan D, Farajallah A, Bertz R. Determination of rifabutin dosing regimen when administered in combination with ritonavir-boosted atazanavir. J Antimicrob Chemother. 2011 Sep;66(9):2075-82. doi: 10.1093/jac/dkr266. Epub 2011 Jun 28. PubMed 21712242 ↗
10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 31, 2013, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT00646776
Lead sponsor
Bristol-Myers Squibb
Responsible party
Sponsor
First posted
Mar 31, 2008
Start date
Apr 2008
Primary completion
Aug 2008
Completion
Aug 2008
Results posted
Jan 5, 2011
Last update
Jan 31, 2013

Study contacts

Bristol-Myers Squibb
study director · Bristol-Myers Squibb

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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