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Optimized Background ARVs

Phase 2

HIV Infections | Small molecule | Infectious Disease |Roche Holding AG|Last Updated: Nov 2, 2016

Success Probability

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Market & Valuation

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Trial Design

RandomizedACTIVE_CONTROLLED
Total Trials1
Total Enrollment64

FDA Designations

No designations recorded

Clinical trial landscape

Optimized Background ARVs · 1 trial · 1 indication

Phase 2 1
NCT00089492A Study Comparing the Efficacy and Safety of Once-Daily Fuzeon (Enfuvirtide) Dosing Versus the Currently Recommended Twice-Daily Dosing in Human Immunodeficiency Virus-Type 1 (HIV-1) Infected PatientsHIV Infections
COMPLETED64 Analytics
PHASE2COMPLETED
A Study Comparing the Efficacy and Safety of Once-Daily Fuzeon (Enfuvirtide) Dosing Versus the Currently Recommended Twice-Daily Dosing in Human Immunodeficiency Virus-Type 1 (HIV-1) Infected Patients
HIV InfectionsUnlock trial analytics

Study Endpoints

Primary Endpoints

Viral load.\n\n
Week 48

Secondary Endpoints

CD4 lymphocyte count.
Week 48
AEs, laboratory abnormalities, local injection site reactions, AIDS-defining events.\n
Throughout study
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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
1EXPERIMENTAL -
2ACTIVE_COMPARATOR -

Interventions

NameTypeDescription
Optimized Background ARVsDRUGAs prescribed
enfuvirtide [Fuzeon]DRUG180mg sc once daily for 48 weeks
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Eligibility Criteria

Age Range16 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites27

Inclusion Criteria: * HIV-1 infected adults or adolescents \>=16 years of age; * HIV-1 RNA \>=5000 copies/mL; * prior experience or documented resistance to each of the 3 currently available classes of ARV drugs (nucleoside reverse transcriptase inhibitors, non-nucleoside reverse transcriptase inhi...

Countries:United StatesCanadaPuerto Rico
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Frequently asked questions about Optimized Background ARVs

What is Optimized Background ARVs used for in HIV Infections?

Optimized Background ARVs is an investigational small molecule being studied for the treatment of HIV Infections. It is currently in Phase 2 clinical development. The drug is intended to be used as part of an optimized background regimen for patients with HIV-1 infection.

Who makes Optimized Background ARVs?

Optimized Background ARVs is being developed by Roche Holding AG, which trades under the ticker RHHBY. The company is conducting clinical research on this investigational drug for the treatment of HIV Infections.

What phase is Optimized Background ARVs in?

Optimized Background ARVs is currently in Phase 2 clinical development. It is an investigational drug and has not been approved by regulatory authorities. One Phase 2 clinical trial has been completed for this drug.

What clinical trials is Optimized Background ARVs in?

Optimized Background ARVs has one completed Phase 2 clinical trial, identified as NCT00089492. This study compared the efficacy and safety of once-daily versus twice-daily dosing of Fuzeon (enfuvirtide) in HIV-1 infected patients. The trial enrolled 64 participants across the United States, Canada, and Puerto Rico.

Is Optimized Background ARVs the same as Fuzeon?

Optimized Background ARVs is not the same as Fuzeon (enfuvirtide). In the clinical trial NCT00089492, Optimized Background ARVs was used as the background antiretroviral regimen, while Fuzeon was the investigational drug being tested. The study compared different dosing schedules of Fuzeon in combination with Optimized Background ARVs.