- ICH GCP
- Yhdysvaltain kliinisten tutkimusten rekisteri
- Kliininen tutkimus NCT00646776
Drug Interaction Study
keskiviikko 23. tammikuuta 2013 päivittänyt: 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)
Tutkimuksen yleiskatsaus
Tila
Valmis
Ehdot
Interventio / Hoito
Opintotyyppi
Interventio
Ilmoittautuminen (Todellinen)
85
Vaihe
- Vaihe 1
Yhteystiedot ja paikat
Tässä osiossa on tutkimuksen suorittajien yhteystiedot ja tiedot siitä, missä tämä tutkimus suoritetaan.
Opiskelupaikat
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New Jersey
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Hamilton, New Jersey, Yhdysvallat, 08690
- Bristol-Myers Squibb Clinical Pharmacology Unit
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Osallistumiskriteerit
Tutkijat etsivät ihmisiä, jotka sopivat tiettyyn kuvaukseen, jota kutsutaan kelpoisuuskriteereiksi. Joitakin esimerkkejä näistä kriteereistä ovat henkilön yleinen terveydentila tai aiemmat hoidot.
Kelpoisuusvaatimukset
Opintokelpoiset iät
18 vuotta - 50 vuotta (Aikuinen)
Hyväksyy terveitä vapaaehtoisia
Joo
Sukupuolet, jotka voivat opiskella
Kaikki
Kuvaus
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
Opintosuunnitelma
Tässä osiossa on tietoja tutkimussuunnitelmasta, mukaan lukien kuinka tutkimus on suunniteltu ja mitä tutkimuksella mitataan.
Miten tutkimus on suunniteltu?
Suunnittelun yksityiskohdat
- Ensisijainen käyttötarkoitus: Hoito
- Jako: Satunnaistettu
- Inventiomalli: Rinnakkaistehtävä
- Naamiointi: Ei mitään (avoin tarra)
Aseet ja interventiot
Osallistujaryhmä / Arm |
Interventio / Hoito |
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Active Comparator: A
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Capsule, Oral, 150 mg, once daily, 11 Days
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Active Comparator: B
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Capsules, Oral, 18 Days Rifabutin (150 mg, 2x/wk) Atazanavir (300 mg, once daily) Ritonavir (100 mg, once daily)
Muut nimet:
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Mitä tutkimuksessa mitataan?
Ensisijaiset tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
---|---|---|
Average Area Under the Plasma Concentration-time Curve for 24 Hours (AUC24avg) for Rifabutin (RIB)
Aikaikkuna: 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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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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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)
Aikaikkuna: 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
Aikaikkuna: 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.
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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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Total Area Under the Plasma Concentration-time Curve (AUCtot)
Aikaikkuna: 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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Toissijaiset tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
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Cmax of ATV
Aikaikkuna: 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
Aikaikkuna: 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 ATV.
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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 ATV
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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.
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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.
Aikaikkuna: 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
Aikaikkuna: 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)
Aikaikkuna: 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)
Aikaikkuna: 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)
Aikaikkuna: 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.
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.
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Number of Participants With MAs in Serum Chemistry: Glucose (Fasting Serum), Albumin, Creatine Kinase, Uric Acid, Lactate Dehydrogenase (LDH)
Aikaikkuna: 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).
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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 Urinalysis
Aikaikkuna: 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).
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Pre-dose on Day -1, Day 7 and discharge.
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Number of Participants With Identified Electrocardiogram (ECG) Abnormalities
Aikaikkuna: 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
Aikaikkuna: 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.
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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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Ensisijainen valmistuminen (Todellinen)
Perjantai 1. elokuuta 2008
Opintojen valmistuminen (Todellinen)
Perjantai 1. elokuuta 2008
Opintoihin ilmoittautumispäivät
Ensimmäinen lähetetty
Keskiviikko 26. maaliskuuta 2008
Ensimmäinen toimitettu, joka täytti QC-kriteerit
Keskiviikko 26. maaliskuuta 2008
Ensimmäinen Lähetetty (Arvio)
Maanantai 31. maaliskuuta 2008
Tutkimustietojen päivitykset
Viimeisin päivitys julkaistu (Arvio)
Torstai 31. tammikuuta 2013
Viimeisin lähetetty päivitys, joka täytti QC-kriteerit
Keskiviikko 23. tammikuuta 2013
Viimeksi vahvistettu
Tiistai 1. tammikuuta 2013
Lisää tietoa
Tähän tutkimukseen liittyvät termit
Muita asiaankuuluvia MeSH-ehtoja
- Farmakologisen vaikutuksen molekyylimekanismit
- Infektiota estävät aineet
- Viruksenvastaiset aineet
- Entsyymin estäjät
- HIV-vastaiset aineet
- Antiretroviraaliset aineet
- Proteaasin estäjät
- Bakteerien vastaiset aineet
- Sytokromi P-450 CYP3A:n estäjät
- Sytokromi P-450 -entsyymin estäjät
- HIV-proteaasin estäjät
- Viruksen proteaasin estäjät
- Tuberkulaariset aineet
- Antibiootit, antituberkulaariset
- Ritonaviiri
- Rifabutiini
- Atatsanaviirisulfaatti
Muut tutkimustunnusnumerot
- AI424-360
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Kliiniset tutkimukset Antivirals/HIV
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University of Alabama at BirminghamMobile County Health Deparment; Alabama Department of Public HealthRekrytointiHIV | HIV-testaus | HIV-yhteys hoitoon | HIV-hoitoYhdysvallat
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University of MinnesotaPeruutettuHIV-infektiot | HIV/AIDS | Hiv | Aids | AIDS/HIV-ongelma | AIDS ja infektiotYhdysvallat
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Africa Health Research InstituteLondon School of Hygiene and Tropical Medicine; University College, London; University of Southampton ja muut yhteistyökumppanitRekrytointiHIV | HIV-testaus | Yhteys hoitoonEtelä-Afrikka
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Hospital Clinic of BarcelonaValmisIntegraasi-inhibiittorit, HIV; HIV-PROTEAASIINHIBEspanja
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Erasmus Medical CenterEi vielä rekrytointiaHIV-infektiot | Hiv | HIV-1-infektio | HIV I -infektioAlankomaat
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University of Maryland, BaltimorePeruutettuHiv | Munuaissiirto | HIV-varasto | CCR5Yhdysvallat
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National Taiwan UniversityRekrytointi
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Helios SaludViiV HealthcareTuntematonHiv | HIV-1-infektioArgentiina
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Midway Specialty Care CenterEi vielä rekrytointiaHIV-infektiot | Hiv | HIV-1-infektioYhdysvallat
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University of California, DavisValmis