- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00646776
Drug Interaction Study
January 23, 2013 updated by: Bristol-Myers Squibb
Study to Evaluate the Exposure of Rifabutin Administered in an Alternate Regimen in Combination With Atazanavir and Ritonavir Healthy Subjects
The purpose of this study is to evaluate the exposure of rifabutin (RIB) when administered with atazanavir and ritonavir (ATV/RTV)
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
85
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
New Jersey
-
Hamilton, New Jersey, United States, 08690
- Bristol-Myers Squibb Clinical Pharmacology Unit
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 50 years (Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
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:
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: A
|
Capsule, Oral, 150 mg, once daily, 11 Days
|
Active Comparator: B
|
Capsules, Oral, 18 Days Rifabutin (150 mg, 2x/wk) Atazanavir (300 mg, once daily) Ritonavir (100 mg, once daily)
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Average Area Under the Plasma Concentration-time Curve for 24 Hours (AUC24avg) for Rifabutin (RIB)
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.
|
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.
|
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.
|
Maximum Plasma Concentration (Cmax) of 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.
|
Cmax was derived from plasma concentration versus time for RIB and was recorded directly from experimental observations for each treatment period.
|
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.
|
Minimum Plasma Concentration (Cmin) of 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.
|
Cmin was derived from plasma concentration versus time for RIB.
|
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.
|
AUC24avg 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.
|
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
|
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.
|
Cmax of 25-O-Desacetylrifabutin (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.
|
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.
|
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.
|
Cmin of 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.
|
Cmin was derived from plasma concentration versus time for 25-O-Desacetyl-RIB.
|
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.
|
Total Area Under the Plasma Concentration-time Curve (AUCtot)
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.
|
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.
|
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.
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Cmax of 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.
|
Cmax was derived from the plasma concentration versus time for ATV and was recorded directly from experimental observations for each treatment period.
|
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.
|
Cmin of 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.
|
Cmin was derived from the plasma concentration versus time for ATV.
|
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.
|
AUC(TAU) 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.
|
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.
|
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.
|
Time to Reach Maximum Observed Plasma Concentration (Tmax) of 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.
|
Tmax was derived from the plasma concentration versus time for ATV and was recorded directly from experimental observations for each treatment period.
|
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.
|
Terminal Elimination Half-life (T-half) of 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.
|
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.
|
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.
|
Cmax of 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.
|
Cmax was derived from the plasma concentration versus time for RTV and was recorded directly from experimental observations for each treatment period.
|
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.
|
Cmin of 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.
|
Cmin was derived from the plasma concentration versus time for RTV.
|
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.
|
AUC(TAU) 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.
|
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.
|
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.
|
Tmax of 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.
|
Tmax was derived from the plasma concentration versus time for RTV and was recorded directly from experimental observations for each treatment period.
|
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.
|
T-half of 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.
|
T-half was obtained directly from the concentration-time data.
|
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.
|
Number of Participants Who Died, Experienced Other Serious Adverse Events (SAEs), Experienced Adverse Events (AEs) and Experienced Events Leading to Discontinuation.
Time Frame: From Day 1 to 30 days after the last dose of study drug.
|
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.
|
From Day 1 to 30 days after the last dose of study drug.
|
Number of Participants With Marked Abnormalities (MAs) in Hematology: Hemoglobin, Hematocrit, Platelet Count and Leukocytes
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.
|
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).
|
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.
|
Number of Participants With MAs in Hematology: Neutrophils + Bands (Absolute), Lymphocytes (Absolute), Monocytes (Absolute), Basophils (Absolute) and Eosinophils (Absolute)
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.
|
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.
|
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.
|
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)
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.
|
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).
|
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.
|
Number of Participants With MAs in Serum Chemistry: Chloride (Serum), Calcium (Total), Protein (Total), Bicarbonate, Phosphorous (Inorganic)
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.
|
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).
|
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.
|
Number of Participants With MAs in Serum Chemistry: Glucose (Fasting Serum), Albumin, Creatine Kinase, Uric Acid, Lactate Dehydrogenase (LDH)
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.
|
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).
|
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.
|
Number of Participants With MAs in Urinalysis
Time Frame: Pre-dose on Day -1, Day 7 and discharge.
|
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).
|
Pre-dose on Day -1, Day 7 and discharge.
|
Number of Participants With Identified Electrocardiogram (ECG) Abnormalities
Time Frame: Pre-dose on Day -1 and study discharge.
|
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.
|
Pre-dose on Day -1 and study discharge.
|
Number of Participants With Clinically Significant Vital Signs or Physical Examination Findings
Time Frame: Vital signs:screening, prior to dosing on Day 1, Day 7, study discharge. Physical examination:screening, Day -1, Day 7, study discharge
|
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.
|
Vital signs:screening, prior to dosing on Day 1, Day 7, study discharge. Physical examination:screening, Day -1, Day 7, study discharge
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
April 1, 2008
Primary Completion (Actual)
August 1, 2008
Study Completion (Actual)
August 1, 2008
Study Registration Dates
First Submitted
March 26, 2008
First Submitted That Met QC Criteria
March 26, 2008
First Posted (Estimate)
March 31, 2008
Study Record Updates
Last Update Posted (Estimate)
January 31, 2013
Last Update Submitted That Met QC Criteria
January 23, 2013
Last Verified
January 1, 2013
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Molecular Mechanisms of Pharmacological Action
- Anti-Infective Agents
- Antiviral Agents
- Enzyme Inhibitors
- Anti-HIV Agents
- Anti-Retroviral Agents
- Protease Inhibitors
- Anti-Bacterial Agents
- Cytochrome P-450 CYP3A Inhibitors
- Cytochrome P-450 Enzyme Inhibitors
- HIV Protease Inhibitors
- Viral Protease Inhibitors
- Antitubercular Agents
- Antibiotics, Antitubercular
- Ritonavir
- Rifabutin
- Atazanavir Sulfate
Other Study ID Numbers
- AI424-360
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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Assiut UniversityCompletedLiver Cirrhoses | Chronic Hepatitis c | Directly Acting AntiviralsEgypt
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Hospices Civils de LyonCompletedHepatocellular Carcinoma | Hepatitis C | Direct Acting Antivirals
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University of Alabama at BirminghamMobile County Health Deparment; Alabama Department of Public HealthRecruitingHIV | HIV Testing | HIV Linkage to Care | HIV TreatmentUnited States
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ANRS, Emerging Infectious DiseasesHopital Universitaire Robert-Debre; Institut de Recherche pour le Developpement and other collaboratorsUnknownHIV | HIV-uninfected Children | Children Exposed to HIVCameroon
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French National Agency for Research on AIDS and...Elizabeth Glaser Pediatric AIDS FoundationCompletedPartner HIV Testing | Couple HIV Counseling | Couple Communication | HIV IncidenceCameroon, Dominican Republic, Georgia, India
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University of MinnesotaWithdrawnHIV Infections | HIV/AIDS | Hiv | AIDS | Aids/Hiv Problem | AIDS and InfectionsUnited States
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CDC FoundationGilead SciencesUnknownHIV Preexposure Prophylaxis | HIV ChemoprophylaxisUnited States
Clinical Trials on Rifabutin
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PfizerCompletedTuberculosis | Non-tuberculous Mycobacterial Diseases | Inhibition of Disseminated Mycobacterium Avium Complex Disease Associated With HIV Infections
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BioVersys AGCW-Research and Management GmbHRecruitingBacterial InfectionsAustria
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PfizerCompletedTuberculosis | Non-tuberculous Mycobacterial Diseases (Including MAC Disease)
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BioVersys AGCRU Hungary Kft; CRU Hungary Early Phase UnitCompleted
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University of Southern CaliforniaRecruitingDrug Drug InteractionUnited States
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The University of Texas Health Science Center at...PfizerCompletedNontuberculous Mycobacterial InfectionsUnited States
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PfizerCompleted
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Centers for Disease Control and PreventionUS Department of Veterans AffairsCompletedHIV Infections | TuberculosisUnited States, Canada
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PharmaciaCompletedHIV Infections | Mycobacterium Avium-intracellulare InfectionUnited States, Canada
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Cadrock Pty. Ltd.Centre for Digestive Diseases, AustraliaTerminatedCoronary Heart Disease | Chlamydophila Pneumoniae InfectionsAustralia