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Atazanvir/ritonavir+ efavirenz

Phase 3

HIV Infections | Small molecule | Infectious Disease |Bristol-Myers Squibb Company|Last Updated: Apr 14, 2011

Success Probability

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Market & Valuation

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Trial Design

RandomizedCONTROLLED
Total Trials1
Total Enrollment60

FDA Designations

No designations recorded

Clinical trial landscape

Atazanvir/ritonavir+ efavirenz · 1 trial · 1 indication

Phase 3 1
NCT00135343A Pilot Study of Atazanavir/Ritonavir/Efavirenz as a Nucleoside Sparing RegimenHIV Infections
COMPLETED60 Analytics
PHASE3COMPLETED
A Pilot Study of Atazanavir/Ritonavir/Efavirenz as a Nucleoside Sparing Regimen
HIV InfectionsUnlock trial analytics

Study Endpoints

Primary Endpoints

Mean percent change from baseline in fasting plasma triglycerides at Week 8

Secondary Endpoints

Incidence of grade 2-4 elevation of fasting plasma triglycerides at Week (Wk) 8, 24 and 48
The mean percent change from baseline in fasting plasma triglycerides at Wk 24 and 48
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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL

Treatment Arms

ArmTypeDescription
AEXPERIMENTAL -
BEXPERIMENTAL -

Interventions

NameTypeDescription
Atazanvir/ritonavir + efavirenzDRUGCapsules (ATV and RTV) Tablets (EFV), Oral, ATV 300 mg + RTV 100 mg + EFV 600 mg, Once daily, 48 weeks.
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites15

Inclusion Criteria: * Provide written informed consent * HIV positive with plasma HIV RNA viral load of ≥ 1000 copies/mL and CD4 cell count of ≥ 50 cells/mm3 * Antiretroviral (ARV) naive prior to enrollment * Normal plasma triglycerides ≤ 200 mg/dL * Women of child-bearing age must use effective ba...

Countries:United States
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Frequently asked questions about Atazanvir/ritonavir+ efavirenz

What is Atazanavir/ritonavir + efavirenz used for?

Atazanavir/ritonavir + efavirenz is used for the treatment of HIV infections. It is a combination regimen being studied as a nucleoside-sparing approach, meaning it avoids the use of nucleoside reverse transcriptase inhibitors. The drug is currently in Phase 3 clinical development for this indication.

Who makes Atazanavir/ritonavir + efavirenz?

Atazanavir/ritonavir + efavirenz is being developed by Bristol-Myers Squibb Company, which trades under the ticker BMY. The company is conducting clinical trials to evaluate this combination regimen for the treatment of HIV infections.

What phase is Atazanavir/ritonavir + efavirenz in?

Atazanavir/ritonavir + efavirenz is in Phase 3 clinical development. It is an investigational combination regimen for HIV infections and has not been approved by regulatory authorities. One Phase 3 trial has been completed to evaluate its safety and efficacy.

What clinical trials is Atazanavir/ritonavir + efavirenz in?

Atazanavir/ritonavir + efavirenz has one completed Phase 3 trial, NCT00135343, titled "A Pilot Study of Atazanavir/Ritonavir/Efavirenz as a Nucleoside Sparing Regimen." This trial enrolled 60 participants with HIV infections in the United States and was a randomized, controlled study.

Is Atazanavir/ritonavir + efavirenz the same as atazanavir/ritonavir and efavirenz?

Atazanavir/ritonavir + efavirenz is a combination regimen that includes the drugs atazanavir, ritonavir, and efavirenz. It is being studied as a single treatment approach for HIV infections, combining these three antiretroviral agents to provide a nucleoside-sparing option.