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Atazanavir + Ritonavir + Combivir

Phase 1

HIV Infection | Small molecule | Infectious Disease |Bristol-Myers Squibb Company|Last Updated: Nov 16, 2011

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
UNCONTROLLEDBiomarker
Total Trials1
Total Enrollment69
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00326716Pharmacokinetics of Atazanavir/Ritonavir in HIV-1 Infected Pregnant WomenPHASE1 COMPLETED 69 — — Jun 1, 2006Aug 1, 2009Nov 16, 20116 United States, Puerto Rico +1
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Study Endpoints
Primary Endpoints
Infant Gestational Age at Delivery
At the time of delivery
Infant Gender
At the time of delivery
Infant Race
At the time of delivery
Mean ATV Maximum Plasma Concentration (Cmax) in One Dosing Interval
Pregnancy Weeks 12 to 28, 28 to 36, and 4-6 Weeks Postpartum

Cmax = maximum observed plasma concentration of atazanavir at specified time points.

Mean RTV Maximum Plasma Concentration (Cmax) in One Dosing Interval
Pregnancy Weeks 12 to 28, 28 to 36, and 4-6 Weeks Postpartum

Cmax = maximum observed plasma concentration of ritonavir at specified time points.

Mean ATV Area Under the Concentration Curve (AUC TAU)
Pregnancy Weeks 12 to 28, 28 to 36, and 4-6 Weeks Postpartum

AUC = area under the concentration curve (AUC \[TAU\]) of atazanavir in one dosing interval from time zero to 24 hours.

Mean RTV Area Under the Concentration Curve (AUC TAU)
Pregnancy Weeks 12 to 28, 28 to 36, and 4-6 Weeks Postpartum

AUC = area under the concentration curve (AUC \[TAU\]) of ritonavir in one dosing interval.

Mean ATV Trough Plasma Concentration (Cmin) 24 Hours Following the Daily Dose
Pregnancy Weeks 12 to 28, 28 to 36, and 4-6 Weeks Postpartum at 24 hours following the daily dose.

Cmin = plasma concentration 24 hours post dose of atazanavir at specified time points.

Mean RTV Trough Plasma Concentration (Cmin) 24 Hours Following the Daily Dose
Pregnancy Weeks 12 to 28, 28 to 36, and 4-6 Weeks Postpartum at 24 hours following the daily dose.

Cmin = plasma concentration 24 hours post dose of ritonavir at specified time points.

Mean ATV Terminal Elimination Half Life (T 1/2)
Pregnancy Weeks 12 to 28, 28 to 36, and 4-6 Weeks Postpartum

T 1/2 = terminal elimination half life of atazanavir at specified time points.

Mean RTV Terminal Elimination Half Life (T 1/2)
Pregnancy Weeks 12 to 28, 28 to 36, and 4-6 Weeks Postpartum

T 1/2 = terminal elimination half life of ritonavir at specified time points.

Mean ATV Time of Maximum Observed Plasma Concentration (Tmax)
Pregnancy Weeks 12 to 28, 28 to 36, and 4-6 Weeks Postpartum

Tmax = time to reach maximum observed plasma concentration of atazanavir at specified time points.

Mean RTV Time of Maximum Observed Plasma Concentration (Tmax)
Pregnancy Weeks 12 to 28, Weeks 28 to 36, and 4-6 Weeks Postpartum

Tmax = time to reach the maximum observed plasma concentration of ritonavir at specified time points.

Secondary Endpoints
Maternal HIV Ribonucleic Acid (RNA) Level on Day of Delivery
Day of Delivery ± 2 Days
Median Change From Baseline to Day of Delivery in Maternal HIV RNA Level
Baseline, Day of Delivery ± 2 Days
Mean HIV RNA Level at Baseline
Baseline
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Study Design & Arms
AllocationNON_RANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
TreatmentEXPERIMENTAL -
Interventions
NameTypeDescription
Atazanavir + Ritonavir + CombivirDRUGCapsules, tablets, Oral, initially ATV 300 mg + RTV 100 mg + ZDV/3TC 300/150 mg, dose escalated to ATV 400 mg + RTV 100 mg + ZDV/3TC 300/150 mg, ATV and RTV once daily, lamivudine (ZDV) / zidovudine (3TC) twice daily (BID), up to 36 weeks
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Eligibility Criteria
Age Range18 Years — N/A
SexFEMALE
Healthy VolunteersNo
Study Sites6

Inclusion Criteria: * HIV-infected pregnant women * \> 18 years of age * Between week 12 and 32 gestation * CD4 \> 200 cells/mm³ * Treatment-naive with HIV RNA \> 400 c/mL, on HAART with HIV RNA \<50 c/mL, or previously treated with ATV (\< 3 weeks) with HIV RNA\>400 c/mL

Countries:United StatesPuerto RicoSouth Africa
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