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Nevirapine

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

NO_TREATMENT_CONTROLLED
Total Trials1
Total Enrollment46

FDA Designations

No designations recorded

Clinical trial landscape

Nevirapine · 1 trial · 1 indication

Phase 1 1
NCT00162149ATV/Ritonavir Nevirapine Interaction (USPAC)HIV Infections
COMPLETED46 Analytics
PHASE1COMPLETED
ATV/Ritonavir Nevirapine Interaction (USPAC)
HIV InfectionsUnlock trial analytics

Study Endpoints

Primary Endpoints

Steady state pharmacokinetics of atazanavir/ritonavir 300/100mg & 400/100mg each co-administered w/ nevirapine 200mg twice-daily w/ 2 to 3 nucleoside reverse transcriptase inhibitors relative to that of a second cohort of subj.

Secondary Endpoints

Steady state PK of 2 atazanavir/ritonavir&nevirapine regimens relative to historic data of atazanavir 400mg in HIV-inf subj;Safety & tolerability of co-admin of atazanavir,ritonavir,&nevirapine in the presence of 2to3 nucleoside rev. transcriptase inhibi
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Study Design & Arms

AllocationNON_RANDOMIZED
MaskingNONE
ModelPARALLEL

Treatment Arms

ArmTypeDescription
A1NO_INTERVENTION -
A2EXPERIMENTAL -
A3EXPERIMENTAL -
B1NO_INTERVENTION -

Interventions

NameTypeDescription
NevirapineDRUGTablets, Oral, 200 mg, Twice daily, 3 days.
Nevirapine + Atazanavir/RitonavirDRUGTablets + Capsules/Capsules, Oral, 200 mg + 300/100 mg, twice daily + once daily, 10 days.
Atazanavir + RitonavirDRUGCapsules/capsules, Oral, 300/100 mg, once daily, 10 days.
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Eligibility Criteria

Age Range18 Years to 55 Years
SexALL
Healthy VolunteersNo
Study Sites3

Inclusion Criteria: * signed informed consent form * For Cohort 1, HIV-infected subjects receiving nevirapine 200 mg twice-daily and 2 to 3 NRTIs for at least 6 weeks * For Cohort 2, HIV-infected subjects receiving atazanavir 300 mg and ritonavir 100 mg once-daily and 2 to 3 NRTIs for at least 6 we...

Countries:United StatesUnited Kingdom
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Frequently asked questions about Nevirapine

What is Nevirapine used for in HIV Infections?

Nevirapine is a small molecule drug being studied for the treatment of HIV Infections. It is currently in Phase 1 clinical development as an investigational therapy. The drug is being evaluated in a clinical trial to assess its interaction with other antiretroviral medications in patients with HIV.

Who makes Nevirapine?

Nevirapine is being developed by Bristol-Myers Squibb Company, a biopharmaceutical company listed on the New York Stock Exchange under the ticker symbol BMY. The company is conducting clinical research to evaluate the drug's safety and pharmacokinetics in the context of HIV treatment.

What phase is Nevirapine in?

Nevirapine is in Phase 1 clinical development. It is an investigational drug and has not been approved by regulatory authorities for the treatment of HIV Infections. The Phase 1 trial has been completed, and the drug remains under evaluation for its potential use in HIV therapy.

What clinical trials is Nevirapine in?

Nevirapine has one completed clinical trial registered under NCT00162149, titled 'ATV/Ritonavir Nevirapine Interaction (USPAC)'. This Phase 1 study enrolled 46 participants with HIV Infections and was conducted in the United States and United Kingdom. The trial was not randomized or double-blinded and used a no-treatment control.

How does Nevirapine work?

Nevirapine is a small molecule drug being investigated for HIV Infections. As a non-nucleoside reverse transcriptase inhibitor, it works by binding to and inhibiting the reverse transcriptase enzyme, which is essential for HIV replication. This mechanism helps reduce viral load in infected individuals.