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CLINICAL TRIALS PROFILE FOR VIRAMUNE XR

Clinical Trials for Viramune Xr

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Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00002166	An Open-Label, Non-Randomized Trial to Evaluate the Tolerability and Safety of Viramune (Nevirapine) in Adult and Pediatric Patients With Progressive HIV Disease	Completed	Boehringer Ingelheim	Phase 3	1969-12-31	To provide access to Viramune and to evaluate the tolerance and safety of Viramune in patients with progressive, symptomatic HIV disease who failed or are intolerant to currently approved treatment for HIV-1 infection and who are unable to participate in another Viramune controlled clinical trial and have a compelling need for anti-HIV treatment.
NCT00002194	An Open-Label Study in HIV+ Patients to Determine the Effects of Nevirapine (Viramune) on the Pharmacokinetics of Clarithromycin and Activity of Cytochrome 3A4.	Completed	Boehringer Ingelheim	Phase 1	1969-12-31	To evaluate the potential pharmacokinetic interaction between nevirapine and clarithromycin, and to determine the effects of nevirapine on cytochrome P450 3A4 (CYP3A4) activity in vivo.
NCT00002368	The Safety and Effectiveness of Nevirapine Plus Lamivudine Plus Other Anti-HIV Drugs	Completed	Boehringer Ingelheim	Phase 3	1969-12-31	To evaluate the tolerance, safety, and effectiveness of Viramune in preventing clinical AIDS progression events or death when used in combination with Lamivudine and background nucleoside therapy.
NCT00002381	The Safety and Effectiveness of Nevirapine Plus Nelfinavir in HIV-1 Infected Patients Who Have Taken Stavudine	Completed	Boehringer Ingelheim	Phase 1	1969-12-31	To determine the potential effects of 28 days of nevirapine treatment on the steady-state pharmacokinetics of nelfinavir and of stavudine (d4T), and to further evaluate the pharmacokinetics of nevirapine in combination with nelfinavir, and d4T compared to the historical controls treated with nevirapine but without nelfinavir or d4T. To determine the efficacy of long-term combination therapy of nevirapine, nelfinavir and d4T on viral load in patients who are non-nucleoside reverse transcriptase inhibitor (NNRTI) and protease inhibitor naive, and have <= 6 months prior d4T exposure at the time of screening.
NCT00002418	The Safety and Effectiveness of Didanosine Plus Stavudine Plus Nevirapine Combined With MKC-442 in HIV-Infected Patients Who Have Not Had Success With Protease Inhibitors	Terminated	Boehringer Ingelheim	Phase 2	1969-12-31	The purpose of this study is to see if it is safe and effective to give a new anti-HIV drug combination to HIV-infected patients who have never taken nonnucleoside reverse transcriptase inhibitors (NNRTIs) and who have failed to respond to protease inhibitors (PIs). The drug combination will contain didanosine (ddI) plus stavudine (d4T) plus nevirapine (NVP) plus MKC-442. Hydroxyurea (HU) may be added.
NCT00002418	The Safety and Effectiveness of Didanosine Plus Stavudine Plus Nevirapine Combined With MKC-442 in HIV-Infected Patients Who Have Not Had Success With Protease Inhibitors	Terminated	Triangle Pharmaceuticals	Phase 2	1969-12-31	The purpose of this study is to see if it is safe and effective to give a new anti-HIV drug combination to HIV-infected patients who have never taken nonnucleoside reverse transcriptase inhibitors (NNRTIs) and who have failed to respond to protease inhibitors (PIs). The drug combination will contain didanosine (ddI) plus stavudine (d4T) plus nevirapine (NVP) plus MKC-442. Hydroxyurea (HU) may be added.
NCT00002418	The Safety and Effectiveness of Didanosine Plus Stavudine Plus Nevirapine Combined With MKC-442 in HIV-Infected Patients Who Have Not Had Success With Protease Inhibitors	Terminated	Bristol-Myers Squibb	Phase 2	1969-12-31	The purpose of this study is to see if it is safe and effective to give a new anti-HIV drug combination to HIV-infected patients who have never taken nonnucleoside reverse transcriptase inhibitors (NNRTIs) and who have failed to respond to protease inhibitors (PIs). The drug combination will contain didanosine (ddI) plus stavudine (d4T) plus nevirapine (NVP) plus MKC-442. Hydroxyurea (HU) may be added.
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