- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT00646776
Drug Interaction Study
23. januar 2013 opdateret af: 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)
Studieoversigt
Status
Afsluttet
Betingelser
Intervention / Behandling
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
85
Fase
- Fase 1
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
-
-
New Jersey
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Hamilton, New Jersey, Forenede Stater, 08690
- Bristol-Myers Squibb Clinical Pharmacology Unit
-
-
Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
18 år til 50 år (Voksen)
Tager imod sunde frivillige
Ja
Køn, der er berettiget til at studere
Alle
Beskrivelse
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
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
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Aktiv komparator: EN
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Capsule, Oral, 150 mg, once daily, 11 Days
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Aktiv komparator: B
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Capsules, Oral, 18 Days Rifabutin (150 mg, 2x/wk) Atazanavir (300 mg, once daily) Ritonavir (100 mg, once daily)
Andre navne:
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Average Area Under the Plasma Concentration-time Curve for 24 Hours (AUC24avg) for Rifabutin (RIB)
Tidsramme: 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.
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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.
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Maximum Plasma Concentration (Cmax) of RIB
Tidsramme: 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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Cmax was derived from plasma concentration versus time for RIB and was recorded directly from experimental observations for each treatment period.
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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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Minimum Plasma Concentration (Cmin) of RIB
Tidsramme: 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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Cmin was derived from plasma concentration versus time for RIB.
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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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AUC24avg for 25-O-Desacetyl-RIB
Tidsramme: 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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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
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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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Cmax of 25-O-Desacetylrifabutin (25-O-Desacetyl-RIB)
Tidsramme: 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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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.
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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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Cmin of 25-O-Desacetyl-RIB
Tidsramme: 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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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.
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Total Area Under the Plasma Concentration-time Curve (AUCtot)
Tidsramme: 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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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.
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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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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Cmax of ATV
Tidsramme: 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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Cmax was derived from the plasma concentration versus time for ATV and was recorded directly from experimental observations for each treatment period.
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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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Cmin of ATV
Tidsramme: 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.
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AUC(TAU) for ATV
Tidsramme: 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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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.
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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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Time to Reach Maximum Observed Plasma Concentration (Tmax) of ATV
Tidsramme: 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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Tmax was derived from the plasma concentration versus time for ATV and was recorded directly from experimental observations for each treatment period.
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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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Terminal Elimination Half-life (T-half) of ATV
Tidsramme: 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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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.
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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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Cmax of RTV
Tidsramme: 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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Cmax was derived from the plasma concentration versus time for RTV and was recorded directly from experimental observations for each treatment period.
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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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Cmin of RTV
Tidsramme: 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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Cmin was derived from the plasma concentration versus time for RTV.
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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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AUC(TAU) for RTV
Tidsramme: 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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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.
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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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Tmax of RTV
Tidsramme: 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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Tmax was derived from the plasma concentration versus time for RTV and was recorded directly from experimental observations for each treatment period.
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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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T-half of RTV
Tidsramme: 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.
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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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Number of Participants Who Died, Experienced Other Serious Adverse Events (SAEs), Experienced Adverse Events (AEs) and Experienced Events Leading to Discontinuation.
Tidsramme: From Day 1 to 30 days after the last dose of study drug.
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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.
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From Day 1 to 30 days after the last dose of study drug.
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Number of Participants With Marked Abnormalities (MAs) in Hematology: Hemoglobin, Hematocrit, Platelet Count and Leukocytes
Tidsramme: 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.
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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).
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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.
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Number of Participants With MAs in Hematology: Neutrophils + Bands (Absolute), Lymphocytes (Absolute), Monocytes (Absolute), Basophils (Absolute) and Eosinophils (Absolute)
Tidsramme: 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.
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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.
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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.
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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)
Tidsramme: 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.
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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).
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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.
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Number of Participants With MAs in Serum Chemistry: Chloride (Serum), Calcium (Total), Protein (Total), Bicarbonate, Phosphorous (Inorganic)
Tidsramme: 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).
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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)
Tidsramme: 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
Tidsramme: 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.
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Number of Participants With Identified Electrocardiogram (ECG) Abnormalities
Tidsramme: 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.
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Pre-dose on Day -1 and study discharge.
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Number of Participants With Clinically Significant Vital Signs or Physical Examination Findings
Tidsramme: 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
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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Publikationer og nyttige links
Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart
1. april 2008
Primær færdiggørelse (Faktiske)
1. august 2008
Studieafslutning (Faktiske)
1. august 2008
Datoer for studieregistrering
Først indsendt
26. marts 2008
Først indsendt, der opfyldte QC-kriterier
26. marts 2008
Først opslået (Skøn)
31. marts 2008
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
31. januar 2013
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
23. januar 2013
Sidst verificeret
1. januar 2013
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
- Molekylære mekanismer for farmakologisk virkning
- Anti-infektionsmidler
- Antivirale midler
- Enzymhæmmere
- Anti-HIV-midler
- Anti-retrovirale midler
- Proteasehæmmere
- Antibakterielle midler
- Cytokrom P-450 CYP3A-hæmmere
- Cytokrom P-450 enzymhæmmere
- HIV-proteasehæmmere
- Virale proteasehæmmere
- Antituberkulære midler
- Antibiotika, Antituberkulær
- Ritonavir
- Rifabutin
- Atazanavirsulfat
Andre undersøgelses-id-numre
- AI424-360
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Kliniske forsøg med Antivirals/HIV
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Castagna AntonellaViiV HealthcareRekrutteringHIV-1-infektion | Multi-antiviral modstandItalien
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University of California, Los AngelesGilead SciencesAfsluttetHIV/AIDS | Mitokondriel ændring | Antiviral toksicitet | Antiviral lægemiddelbivirkningForenede Stater
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Perouse MedicalEclevar MedtechAfsluttetKemoterapi | Antibiotika | Parenteral ernæring | Venøs adgang | Venøst system | Antiviral | TransfusionsblodFrankrig
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Assiut UniversityUkendtAntiviral lægemiddelbivirkning
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TheratechnologiesICON Clinical Research; Excelsus Statistics Inc.; Health Psychology Research...RekrutteringHIV-infektioner | Multi-antiviral modstandForenede Stater
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University Hospital, LimogesRekrutteringCytomegalovirus infektioner | Hæmatopoietisk stamcelletransplantation | Antivirale midler | Antiviral lægemiddelresistensFrankrig
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University of Texas Southwestern Medical CenterAfsluttetCOVID-19 | Respiratorisk viral infektion | Antiviral behandlingForenede Stater
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Tufts Medical CenterMerck Sharp & Dohme LLCAktiv, ikke rekrutterendeNeutropeni | Cytomegalovirus infektioner | Cytomegalovirus sygdom | Hjertetransplantationsinfektion | Antiviral toksicitetForenede Stater
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Augusta UniversityAfsluttetKarsygdomme | Ændringer i kropsvægt | Kardiovaskulære abnormiteter | HIV-1-infektion | Kropsfedtforstyrrelse | HIV-associeret lipodystrofisyndrom | Antiviral lægemiddelbivirkning | Abnormitet af fedtvævForenede Stater
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Tufts Medical CenterRekrutteringNeutropeni | Cytomegalovirus infektioner | Infektion hos faste organtransplantationsmodtagere | Antiviral toksicitetForenede Stater
Kliniske forsøg med Rifabutin
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PfizerAfsluttetTuberkulose | Ikke-tuberkuløse mykobakterielle sygdomme | Hæmning af dissemineret Mycobacterium Avium Complex sygdom forbundet med HIV-infektioner
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BioVersys AGCW-Research and Management GmbHRekrutteringBakterielle infektionerØstrig
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PfizerAfsluttetTuberkulose | Ikke-tuberkuløse mykobakterielle sygdomme (inklusive MAC-sygdom)
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BioVersys AGCRU Hungary Kft; CRU Hungary Early Phase UnitAfsluttet
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University of Southern CaliforniaRekrutteringLægemiddel LægemiddelinteraktionForenede Stater
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The University of Texas Health Science Center at...Pfizer; AbbottAfsluttetMycobacterium Avium kompleks lungesygdomForenede Stater
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The University of Texas Health Science Center at...PfizerAfsluttetIkke-tuberkuløse mykobakterielle infektionerForenede Stater
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PfizerAfsluttetSunde frivilligeSingapore
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Centers for Disease Control and PreventionUS Department of Veterans AffairsAfsluttetHIV-infektioner | TuberkuloseForenede Stater, Canada
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PharmaciaAfsluttetHIV-infektioner | Mycobacterium Avium-intracellulare infektionForenede Stater, Canada