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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.
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	National Institute of Allergy and Infectious Diseases (NIAID)	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.
NCT00000770	A Comparative Study of a Combination of Zidovudine, Didanosine, and Double-Blinded Nevirapine Versus a Combination of Zidovudine and Didanosine	Completed	Bristol-Myers Squibb	Phase 2	1969-12-31	To assess the safety and toxicity of zidovudine (AZT)/didanosine (ddI) versus AZT/ddI combined with nevirapine in HIV-infected patients, and to obtain preliminary anti-HIV activity data using immunologic and virologic markers. Previous in vitro studies suggest that HIV that has already developed resistance to AZT and ddI is less able to develop resistance to nevirapine, a non-nucleoside reverse transcriptase inhibitor. Thus, convergent combination therapy with these three drugs in HIV-infected patients may prove more effective.

Clinical Trial Conditions for Nevirapine

Condition Name

Condition Name for Nevirapine
Intervention	Trials
HIV Infections	139
HIV	28
HIV Infection	12
Pregnancy	12

Condition MeSH

Condition MeSH for Nevirapine
Intervention	Trials
HIV Infections	157
Acquired Immunodeficiency Syndrome	26
Infection	19
Communicable Diseases	12

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

Trials by US State

Trials by US State for Nevirapine
Location	Trials
California	45
New York	32
Massachusetts	31
Illinois	29
Texas	28

Clinical Trial Progress for Nevirapine

Clinical Trial Phase

Clinical Trial Phase for Nevirapine
Clinical Trial Phase	Trials
Phase 4	53
Phase 3	39
Phase 2/Phase 3	6

Clinical Trial Status

Clinical Trial Status for Nevirapine
Clinical Trial Phase	Trials
Completed	166
Unknown status	10
Terminated	10

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

Sponsor Type

Sponsor Type for Nevirapine
Sponsor	Trials
Other	198
Industry	90
NIH	89