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Nevirapine

Phase 4

HIV-1 | Small molecule | Infectious Disease |Teva Pharmaceutical Industries Limited|Trials Updated: Aug 25, 2015

Nevirapine development status

Highest phase Phase 4 run by National Center for Women and Children's Health, China CDC (NCT02712801)
Phase scored for TEVAPhase 1
Registered trials 56 across 9 sponsors since Nov 1999

Success Probability

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Market & Valuation

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Trial Design

ACTIVE_CONTROLLED
Total Trials1
Total Enrollment46

FDA Designations

No designations recorded

Nevirapine clinical trials

Nevirapine · 1 trial · 1 indication

Phase 1 1
NCT02202005Multiple Dose BE Study With Nevirapine 400mg PR TabletsHIV-1
COMPLETED46 Analytics
PHASE1COMPLETED
Multiple Dose BE Study With Nevirapine 400mg PR Tablets
HIV-1Unlock trial analytics

Study Endpoints

Primary Endpoints

Plasma concentrations by AUC0 τ,ss (area under the concentration time curve)
Days 14, 28, 42, 56
Cτ,ss (defined as concentration at the end of dosing interval)
Days 14, 28, 42, 56
Cmax,ss (maximum observed plasma concentration)
Days 14, 28, 42, 56

Secondary Endpoints

Percentage of fluctuation over one dosing interval at steady state (Fl(%)
Days 14, 28, 42, 56
Tmax,ss (the time to maximum plasma concentration at steady state)
Days 14, 28, 42, 56
Cmin,ss (minimum plasma concentration at steady state)
Days 14, 28, 42, 56
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Study Design & Arms

AllocationNON_RANDOMIZED
MaskingNONE
ModelCROSSOVER

Treatment Arms

ArmTypeDescription
NevirapineEXPERIMENTAL -
Viramune®ACTIVE_COMPARATOR -

Interventions

NameTypeDescription
NevirapineDRUGNevirapine 400mg PR tablet
Viramune®DRUGViramune® 400 mg Retardtabletten
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Eligibility Criteria

Age Range18 Years to 65 Years
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: 1. Signed and dated written informed consent prior to admission to the study 2. HIV1 infected males or females of 18 to 65 years, nonsmoker (use of cannabis may be accepted) 3. Body weight ≥ 50.0 kg and BMI ≥ 18.0 and ≤ 32.0 kg/m2 4. Absence of clinically significant history of ...

Countries:United Kingdom
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Frequently asked questions about Nevirapine

What is Nevirapine?

Nevirapine is a small molecule drug being developed by Teva Pharmaceutical Industries Limited for HIV-1 infection. It is in Phase 1 clinical development. The program includes one completed Phase 1 trial conducted in the United Kingdom.

What is Nevirapine used for in HIV-1?

Nevirapine is being evaluated for the treatment of HIV-1 infection. It is an investigational small molecule in Phase 1 development, and its use in HIV-1 has been studied in a completed Phase 1 trial. It is not described as approved for this indication.

Who makes Nevirapine?

Nevirapine is being developed by Teva Pharmaceutical Industries Limited, which trades under the ticker TEVA. Teva is the sponsor of the clinical program for this HIV-1 candidate.

What phase is Nevirapine in?

Nevirapine is in Phase 1 clinical development. One Phase 1 trial has been completed, and no active trials are ongoing. The completed study was an active-controlled Phase 1 trial conducted in the United Kingdom.

What clinical trials is Nevirapine in?

Nevirapine has been studied in one completed Phase 1 trial, NCT02202005, titled Multiple Dose BE Study With Nevirapine 400mg PR Tablets. The trial enrolled 46 participants in the United Kingdom and included an active control. It was not randomized or double-blind.