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Atazanvir/ritonavir+ efavirenz

Phase 3

HIV Infections | Small molecule | Infectious Disease |Bristol-Myers Squibb Company|Trials 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

Atazanvir/ritonavir+ efavirenz clinical trials

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 plus efavirenz used for?

Atazanavir/ritonavir plus efavirenz is a combination antiretroviral regimen studied for the treatment of HIV Infections. It combines a boosted protease inhibitor with a non-nucleoside reverse transcriptase inhibitor. The regimen was evaluated as a nucleoside sparing option, meaning it was tested without nucleoside reverse transcriptase inhibitors as part of the background therapy.

Who is developing atazanavir/ritonavir plus efavirenz?

Bristol-Myers Squibb Company, which trades under the ticker BMY, is the developer associated with this atazanavir/ritonavir plus efavirenz regimen. The company sponsored the clinical study of the combination in HIV Infections.

What phase is atazanavir/ritonavir plus efavirenz in?

Atazanavir/ritonavir plus efavirenz has been studied in a Phase 3 clinical trial. The trial has completed, and no active trials of this regimen are currently listed. It is an investigational combination regimen rather than a standalone approved product.

What clinical trial studied atazanavir/ritonavir plus efavirenz?

The regimen was studied in trial NCT00135343, titled A Pilot Study of Atazanavir/Ritonavir/Efavirenz as a Nucleoside Sparing Regimen. It was a Phase 3, controlled, randomized trial that enrolled 60 participants with HIV Infections at sites in the United States. Participants were 18 years and older, and the study did not include healthy volunteers.

How many people were enrolled in the atazanavir/ritonavir plus efavirenz trial?

The Phase 3 trial of atazanavir/ritonavir plus efavirenz, NCT00135343, enrolled 60 participants. It was a randomized and controlled study conducted in the United States in adults with HIV Infections. The trial has completed.