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efavirenz containing antiretroviral regimen

Phase 1

HIV Infections | Small molecule | Infectious Disease |Bristol-Myers Squibb Company|Last Updated: Sep 14, 2010

Success Probability

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Market & Valuation

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Trial Design

ACTIVE_CONTROLLED
Total Trials1
Total Enrollment21

FDA Designations

No designations recorded

Clinical trial landscape

efavirenz containing antiretroviral regimen · 1 trial · 2 indications

Phase 1 1
NCT00162097Pharmacokinetics of Efavirenz in HIV-1 Infected Subjects With Hepatic ImpairmentHIV Infections
COMPLETED21 Analytics
PHASE1COMPLETED
Pharmacokinetics of Efavirenz in HIV-1 Infected Subjects With Hepatic Impairment
HIV InfectionsUnlock trial analytics

Study Endpoints

Primary Endpoints

Maximum Plasma Concentration (Cmax)
Blood samples were collected at time 0 (pre-dose), 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12 and 24 hours post-dose, relative to administration of PM or AM dose.

Cmax was obtained directly from the concentration-time data.

Minimum Plasma Concentration (Cmin)
Blood samples were collected at time 0 (pre-dose), 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12 and 24 hours post-dose, relative to administration of PM or AM dose.

Cmin was obtained directly from the concentration-time data.

Area Under the Plasma Concentration-time Curve Over the Dosing Interval of 24 Hours (AUC[TAU])
Blood samples were collected at time 0 (pre-dose), 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12 and 24 hours post-dose, relative to administration of PM or AM dose.

The AUC(TAU), from time 0 to the time of the last measurable concentration (t), was calculated by the linear trapezoidal rule.

Time to Reach Maximum Observed Plasma Concentration (Tmax)
Blood samples were collected at time 0 (pre-dose), 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12 and 24 hours post-dose, relative to administration of PM or AM dose.

Tmax was obtained directly from the concentration-time data.

Secondary Endpoints

Number of Participants Who Died or Experienced Other Serious Adverse Events (SAEs)
From screening (within 21 days of Day 1 dosing) to the study discharge day (Day 2 for AM dosing or Day 3 for PM dosing). Participants were monitored for SAEs up to 30 days after study discharge.
Number of Participants Who Experienced AEs
From screening (within 21 days of Day 1 dosing) to the study discharge day (Day 2 for AM dosing or Day 3 for PM dosing).
Number of Participants Who Experienced AEs Leading to Study Drug Discontinuation
From screening (within 21 days of Day 1 dosing) to the study discharge day (Day 2 for AM dosing or Day 3 for PM dosing).
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Study Design & Arms

AllocationNON_RANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
EFV600mg Participants With Mild Hepatic ImpairmentEXPERIMENTAL -
EFV600mg Participants With Moderate Hepatic ImpairmentEXPERIMENTAL -
EFV600mg Participants With Severe Hepatic ImpairmentEXPERIMENTAL -
EFV600mg Participants With Normal Hepatic FunctionACTIVE_COMPARATOR -

Interventions

NameTypeDescription
efavirenz containing antiretroviral regimenDRUGCapsule or Tablet, Oral, once daily for 2 days
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites4

Inclusion Criteria: * HIV-1 infection with or without Hepatitis B or C infection * Stable antiretroviral regimen containing efavirenz and nucleoside/nucleotide reverse transcriptase inhibitors (NRTI) for at least 1 month * Mild, moderate or severe hepatic impairment with hepatic cirrhosis Exclusio...

Countries:United StatesItaly
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