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Last Updated: May 23, 2022

CLINICAL TRIALS PROFILE FOR NEVIRAPINE


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All Clinical Trials for Nevirapine

Trial ID Title Status Sponsor Phase Start Date Summary
NCT00000634 ↗ A Pilot Pharmacokinetic Phase I Evaluation of BI-RG-587 in HIV-Infected Children Completed Boehringer Ingelheim N/A 1969-12-31 To generate initial information on the pharmacokinetics (blood levels) and dose proportionality of nevirapine (BI-RG-587) plasma levels in HIV-infected children; to assess the safety and tolerance of single rising oral doses of nevirapine in HIV-infected children; and to confirm that the single doses that achieve certain plasma levels in adults achieve similar levels in HIV-infected children. Test tube studies have shown that nevirapine (BI-RG-587) inhibits replication (reproduction) of HIV. Nevirapine works with zidovudine (AZT) and is active against strains of the virus that are resistant to AZT. Studies of the drug in HIV-infected adults showed no serious adverse effects.
NCT00000634 ↗ A Pilot Pharmacokinetic Phase I Evaluation of BI-RG-587 in HIV-Infected Children Completed National Institute of Allergy and Infectious Diseases (NIAID) N/A 1969-12-31 To generate initial information on the pharmacokinetics (blood levels) and dose proportionality of nevirapine (BI-RG-587) plasma levels in HIV-infected children; to assess the safety and tolerance of single rising oral doses of nevirapine in HIV-infected children; and to confirm that the single doses that achieve certain plasma levels in adults achieve similar levels in HIV-infected children. Test tube studies have shown that nevirapine (BI-RG-587) inhibits replication (reproduction) of HIV. Nevirapine works with zidovudine (AZT) and is active against strains of the virus that are resistant to AZT. Studies of the drug in HIV-infected adults showed no serious adverse effects.
NCT00000649 ↗ An Open-Label, Staggered Rising Dose Cohort Study Assessing the Pharmacokinetics, Safety, and Tolerance of BI-RG-587 in Combination With Zidovudine in Patients With HIV Infection (CD4+ Cell Count < 400/mm3) Completed Boehringer Ingelheim Phase 1 1969-12-31 To assess the safety and tolerance of multiple oral doses of nevirapine in combination with zidovudine (AZT); to get information on the pharmacokinetics (blood levels) and dose proportionality of nevirapine/AZT with multiple dosing; to characterize the pattern of virological activity in vivo (in humans) of nevirapine in combination with AZT; to determine whether development of resistance to either drug is slowed by the use of the combination. Drugs now used in treatment for patients with AIDS show some toxicity which limits their usefulness. In addition, with long-term treatment with AZT, there is evidence of virus resistance to the drug. Compounds that are more effective and less toxic than those in present use would be beneficial, especially if they are active against AZT-resistant viruses. Nevirapine has shown in vitro (test tube studies) activity in inhibiting HIV replication (reproduction). In vitro studies have shown that nevirapine and AZT work together to inhibit HIV replication.
NCT00000747 ↗ An Open-Label, Pilot Study to Evaluate the Development of Resistance to Nevirapine (BI-RG-587) in HIV-Infected Patients With CD4 Cell Count >= 500/mm3 Completed Boehringer Ingelheim Phase 2 1969-12-31 Primary: To evaluate the rate of development of resistance to nevirapine in HIV-1 infected individuals. To evaluate safety of nevirapine in HIV-1 infected individuals with CD4 counts greater than or equal to 500 cells/mm3. Secondary: To evaluate the effect of nevirapine on surrogate markers. The anti-HIV agent nevirapine is associated with rapid emergence of resistance when administered alone or in combination with zidovudine to HIV-infected patients with CD4 counts <= 400 cells/mm3. In persons with less advanced HIV disease and less viral burden, the emergence of resistance may be delayed, thus permitting evaluation for beneficial effect in a population where there is currently no established therapy.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Nevirapine

Condition Name

Condition Name for Nevirapine
Intervention Trials
HIV Infections 148
HIV 31
HIV Infection 13
Pregnancy 12
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Condition MeSH

Condition MeSH for Nevirapine
Intervention Trials
HIV Infections 170
Acquired Immunodeficiency Syndrome 31
Infections 27
Infection 22
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Clinical Trial Locations for Nevirapine

Trials by Country

Trials by Country for Nevirapine
Location Trials
United States 634
Thailand 81
South Africa 47
Spain 47
Brazil 25
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Trials by US State

Trials by US State for Nevirapine
Location Trials
California 48
Massachusetts 38
New York 37
Illinois 33
Florida 32
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Clinical Trial Progress for Nevirapine

Clinical Trial Phase

Clinical Trial Phase for Nevirapine
Clinical Trial Phase Trials
Phase 4 55
Phase 3 43
Phase 2/Phase 3 8
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Clinical Trial Status

Clinical Trial Status for Nevirapine
Clinical Trial Phase Trials
Completed 189
Terminated 11
Unknown status 9
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Clinical Trial Sponsors for Nevirapine

Sponsor Name

Sponsor Name for Nevirapine
Sponsor Trials
National Institute of Allergy and Infectious Diseases (NIAID) 65
Boehringer Ingelheim 48
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) 30
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Sponsor Type

Sponsor Type for Nevirapine
Sponsor Trials
Other 247
NIH 107
Industry 91
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Serving leading biopharmaceutical companies globally:

Mallinckrodt
Express Scripts
McKinsey
Johnson and Johnson
Baxter
Colorcon

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