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Generated: June 17, 2019

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CLINICAL TRIALS PROFILE FOR NEVIRAPINE

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Clinical Trials for Nevirapine

Trial ID Title Status Sponsor Phase Summary
NCT00000634 A Pilot Pharmacokinetic Phase I Evaluation of BI-RG-587 in HIV-Infected Children Completed Boehringer Ingelheim N/A 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 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 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.
Trial ID Title Status Sponsor Phase Summary

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Clinical Trial Conditions for Nevirapine

Condition Name

Condition Name for Nevirapine
Intervention Trials
HIV Infections 138
HIV 28
Pregnancy 12
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Condition MeSH

Condition MeSH for Nevirapine
Intervention Trials
HIV Infections 156
Acquired Immunodeficiency Syndrome 25
Infection 18
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Clinical Trial Locations for Nevirapine

Trials by Country

Trials by Country for Nevirapine
Location Trials
United States 562
Thailand 73
Spain 44
South Africa 37
Puerto Rico 18
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Trials by US State

Trials by US State for Nevirapine
Location Trials
California 45
New York 32
Massachusetts 31
Illinois 29
Florida 28
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Clinical Trial Progress for Nevirapine

Clinical Trial Phase

Clinical Trial Phase for Nevirapine
Clinical Trial Phase Trials
Phase 4 52
Phase 3 38
Phase 2/Phase 3 6
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Clinical Trial Status

Clinical Trial Status for Nevirapine
Clinical Trial Phase Trials
Completed 166
Terminated 10
Unknown status 10
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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) 56
Boehringer Ingelheim 47
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) 24
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Sponsor Type

Sponsor Type for Nevirapine
Sponsor Trials
Other 193
NIH 89
Industry 88
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