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Atazanavir Sulphate+ Ritonavir

Phase 1

HIV Infections | Small molecule | Infectious Disease |Bristol-Myers Squibb Company|Last Updated: Apr 8, 2011

Success Probability

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Market & Valuation

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Trial Design

RandomizedACTIVE_CONTROLLED
Total Trials3
Total Enrollment54

FDA Designations

No designations recorded

Clinical trial landscape

Atazanavir Sulphate+ Ritonavir · 3 trials · 2 indications

Phase 1 3
NCT00362726Drug Interaction Study With Atazanavir Administered With and Without Ritonavir and a Cytochrome P450 Substrate RosiglitazoneHIV Infections
COMPLETED14 Analytics
NCT00357188Dose Finding Confirmation of Atazanavir With Ritonavir and Efavirenz (ATV/RTV + EFV) in Healthy SubjectsHIV Infections
COMPLETED22 Analytics
NCT00357721Atazanavir Twice DailyHIV Infections
COMPLETED18 Analytics
PHASE1COMPLETED
Drug Interaction Study With Atazanavir Administered With and Without Ritonavir and a Cytochrome P450 Substrate Rosiglitazone
HIV InfectionsUnlock trial analytics
PHASE1COMPLETED
Dose Finding Confirmation of Atazanavir With Ritonavir and Efavirenz (ATV/RTV + EFV) in Healthy Subjects
HIV InfectionsUnlock trial analytics
PHASE1COMPLETED
Atazanavir Twice Daily
HIV InfectionsUnlock trial analytics

Study Endpoints

Primary Endpoints

To assess the effect of Atazanavir 400 mg QD and Atazanavir/Ritonavir 300/100 mg QD at steady state on the single dose pharmacokinetics of Rosiglitazone in healthy subjects.
To assess the comparability of atazanavir exposure when dosed in the evening as atazanavir 400 mg with ritonavir 100 mg and with efavirenz 600 mg relative to ATV 300 mg and RTV 100 mg alone in healthy subjects
Assess the pharmacokinetics (PK) of atazanavir administered twice-daily (BID) relative to historical data from atazanavir/ritonavir 300/100 mg, given once-daily.

Secondary Endpoints

To assess the safety and tolerability of Rosiglitazone and Atazanavir coadministration with and without Ritonavir.
To explore the relationship between Atazanavir exposure, CYP2C8 genotype and the pharmacokinetics of Rosiglitazone exposure
To assess the PK of EFV when coadministered with ATV 400 mg and RTV 100 mg in the evening
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Study Design & Arms

AllocationNON_RANDOMIZED
MaskingNONE
ModelCROSSOVER

Treatment Arms

ArmTypeDescription
AACTIVE_COMPARATOR -
BACTIVE_COMPARATOR -
CACTIVE_COMPARATOR -
DACTIVE_COMPARATOR -
EACTIVE_COMPARATOR -
A1ACTIVE_COMPARATOR -
A2ACTIVE_COMPARATOR -
A3ACTIVE_COMPARATOR -

Interventions

NameTypeDescription
Rosiglitazone maleateDRUGTablets, Oral, RGZ 4 mg, once daily, 1 day.
Atazanavir SulphateDRUGCapsules, Oral, ATV 400 mg, once daily, 5 days.
Atazanavir Sulphate + Rosiglitazone maleateDRUGCapsule, Oral, ATV 400 mg + RGZ 4 mg, once daily, 1 day.
Atazanavir Sulphate + RitonavirDRUGCapsules, Oral, ATV 300 mg + RTV 100 mg, once daily, 14 days.
Atazanavir Sulphate + Ritonavir + Rosiglitazone maleateDRUGCapsules/Tablets, Oral, ATV 300 mg + RTV 100 mg + RGZ 4 mg, once daily, 1 day.
Atazanavir Sulphate + Ritonavir + EfavirenzDRUGCapsules/Tablets, oral, ATV 400 mg + RTV 100 mg + EFV 600 mg, once daily, 14 days.
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Eligibility Criteria

Age Range18 Years to 50 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Healthy male and female subjects between the ages 18 to 50 years old with a BMI 18 to 32 kg/m2

Countries:United States
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Frequently asked questions about Atazanavir Sulphate+ Ritonavir

What is Atazanavir Sulphate used for?

Atazanavir Sulphate is an investigational small molecule being developed for the treatment of HIV and HIV Infections. It is currently in Phase 3 clinical development. The drug is being studied in combination with other antiretroviral agents, such as ritonavir, to manage HIV infection in affected patients.

Who makes Atazanavir Sulphate?

Atazanavir Sulphate is being developed by Bristol-Myers Squibb Company, which trades under the ticker symbol BMY. The company is conducting clinical trials to evaluate the drug's safety and efficacy in treating HIV infections, with the most advanced study being a Phase 3 trial.

What phase is Atazanavir Sulphate in?

Atazanavir Sulphate is in Phase 3 clinical development for the treatment of HIV. The most advanced trial is a Phase 3 study evaluating the drug's effects in HIV-infected pediatric patients. This trial has been completed, and the drug remains investigational, not yet approved by regulatory authorities.

What clinical trials is Atazanavir Sulphate in?

Atazanavir Sulphate has been studied in three completed clinical trials. These include NCT00357188 and NCT00357721, both Phase 1 studies in healthy subjects, and NCT01335698, a Phase 3 study in HIV-infected pediatric patients. The Phase 3 trial enrolled 160 participants across multiple countries.

How does Atazanavir Sulphate work?

Atazanavir Sulphate is a protease inhibitor used in the treatment of HIV. It works by inhibiting the HIV protease enzyme, which is essential for the virus to replicate. By blocking this enzyme, the drug prevents the virus from maturing and infecting new cells, thereby reducing viral load in patients.