CLINICAL TRIALS PROFILE FOR VIRAMUNE XR

All Clinical Trials for Viramune Xr

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.

Clinical Trial Conditions for Viramune Xr

Condition Name

Condition Name for Viramune Xr
Intervention	Trials
HIV Infections	30
HIV	3
HIV-1	2
Healthy	2

Condition MeSH

Condition MeSH for Viramune Xr
Intervention	Trials
HIV Infections	33
Acquired Immunodeficiency Syndrome	8
Infections	3
Infection	3

Clinical Trial Locations for Viramune Xr

Trials by Country

Trials by Country for Viramune Xr
Location	Trials
United States	56
Brazil	7
Spain	6
Thailand	5
South Africa	5

Trials by US State

Trials by US State for Viramune Xr
Location	Trials
California	6
New York	4
Rhode Island	4
Missouri	3
Massachusetts	3

Clinical Trial Progress for Viramune Xr

Clinical Trial Phase

Clinical Trial Phase for Viramune Xr
Clinical Trial Phase	Trials
Phase 4	13
Phase 3	6
Phase 2/Phase 3	1

Clinical Trial Status

Clinical Trial Status for Viramune Xr
Clinical Trial Phase	Trials
Completed	39
Terminated	3

Clinical Trial Sponsors for Viramune Xr

Sponsor Name

Sponsor Name for Viramune Xr
Sponsor	Trials
Boehringer Ingelheim	26
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)	5
National Institute of Allergy and Infectious Diseases (NIAID)	5

Sponsor Type

Sponsor Type for Viramune Xr
Sponsor	Trials
Industry	33
Other	30
NIH	13