Clinical trials: Nevirapine
Healthy
Pharmacokinetic Properties of Two Dosages Nevirapine Extended Release (XR) Formulations Compared to VIRAMUNE® Tablet as Well as to Nevirapine XR Tablet in Healthy Male Volunteers
Study to determine the pharmacokinetic properties of 200 mg (2 x 100 mg tablets once daily) and 300 mg (3 x 100 mg tablets once daily) Nevirapine extended release formulations and to estimate relative bioavailability of these…
- Trial name
- NCT02184312
- Testing
- Nevirapine XR low dose, Nevirapine XR medium dose, Nevirapine XR high dose
- Volunteers
- 96 people, healthy volunteers welcome
- Sponsor
- Boehringer Ingelheim
HIV Infections
Nevirapine or Atazanavir/Ritonavir Given With Emtricitabine/Tenofovir in Human Immunodeficiency Virus (HIV)-1-infected Treatment Naive Adults
Primary purpose of this study is to compare the efficacy and safety of two different nevirapine (Viramune) dosing regimens (once daily (QD) and twice daily (BID) application) and of atazanavir/ritonavir (Reyataz/Norvir), all on…
- Trial name
- NCT00389207
- Testing
- nevirapine bid, nevirapine qd, atazanavir
- Where
- 68 sites in Argentina, Germany and 8 more
- Volunteers
- 576 people
- Sponsor
- Boehringer Ingelheim
HIV Infections
Study of Nevirapine and Prednisone to Determine the Safety and Effectiveness in Preventing Nevirapine Associated Rash in Human Immunodeficiency Virus (HIV) Infected Patients
Study to determine the incidence of rash between the group receiving nevirapine without prednisone and the group receiving nevirapine with prednisone
- Trial name
- NCT02184299
- Testing
- Nevirapine, Prednisone
- Volunteers
- 138 people
- Sponsor
- Boehringer Ingelheim
HIV Infections
VERxVE Study on Efficacy and Safety of Nevirapine XR in Comparison to Nevirapine IR With Truvada in Naive HIV+ Patients
The primary objective of this study is to evaluate the efficacy of 400 mg QD nevirapine extended release (NVP XR) formulation versus 200 mg BID nevirapine immediate release (NVP IR) in ARV therapy naïve HIV-1 infected patients…
- Trial name
- NCT00561925
- Testing
- nevirapine IR, nevirapine XR
- Where
- 202 sites in United States, Argentina and 19 more
- Volunteers
- 1,068 people
- Sponsor
- Boehringer Ingelheim
HIV Infections
A Multi-Center, Placebo-Controlled, Double-Blind, Randomized Trial Comparing the Virologic and Immunologic Activities of 400 Mg Nevirapine in Combination With Zidovudine Versus Zidovudine Alone in Asymptomatic HIV-1 Infected Patients With 4-12 Months of Prior Zidovudine Therapy and 200-500 CD4+ Cell
PRIMARY: To compare the virologic activity (quantitative RNA PCR, quantitative PBMC) of the combination of nevirapine and zidovudine (AZT) versus AZT alone after 3 and 6 months of treatment.
- Trial name
- NCT00002323
- Testing
- Nevirapine, Zidovudine
- Where
- 5 sites in United States
- Volunteers
- 60 people
- Sponsor
- Boehringer Ingelheim
HIV Infections
A Phase I Multiple Dose Pharmacokinetic Study of Nevirapine Extended Release (XR) in HIV-1 Infected Children.
The primary objective is to establish the pharmacokinetic (PK) profile at steady state of nevirapine XR in HIV infected children from >=3 to <18 years of age.
- Trial name
- NCT00905489
- Testing
- Nevirapine Immediate Release (IR), Nevirapine Extended Release (XR)
- Where
- 10 sites in United States, Botswana and 2 more
- Volunteers
- 85 people
- Sponsor
- Boehringer Ingelheim
HIV Infections
Trial to Evaluate Steady State Pharmacokinetic Parameters, Efficacy and Safety of Nevirapine in Antiretroviral Drug naïve Pediatric Patients
Trial to evaluate steady state pharmacokinetic parameters of nevirapine 150mg/m2 and nevirapine 4 or 7 mg/kg after 4 weeks, and efficacy and safety of the dosing when administered for 48 weeks in antiretroviral drug naïve…
- Trial name
- NCT00273975
- Testing
- Nevirapine, Lamivudine, Zidovudine
- Where
- 4 sites in South Africa
- Volunteers
- 123 people
- Sponsor
- Boehringer Ingelheim
HIV Infections
A Study of ABT-378/Ritonavir Combination in HIV-Infected Patients Who Have Taken Protease Inhibitors
The purpose of this study is to see if it is safe and effective to give ABT-378/ritonavir combination plus nevirapine plus two nucleoside transcriptase inhibitors to HIV-infected patients who previously have taken protease…
- Trial name
- NCT00004580
- Testing
- Lopinavir/Ritonavir, Nevirapine
- Where
- 10 sites in United States
- Sponsor
- Abbott
HIV Infections
Non-interventional Observational Study With Viramune® in HIV to Evaluate Gender Specific Data
The question that prompted this study is the extent to which results from clinical trials can be translated into everyday practice (external validity).
- Trial name
- NCT01134939
- Where
- 34 sites in Germany
- Volunteers
- 265 people
- Sponsor
- Boehringer Ingelheim
HIV Infections
An Open-Label Study in HIV+ Patients to Determine the Effects of Nevirapine (Viramune) on the Pharmacokinetics of Clarithromycin and Activity of Cytochrome 3A4.
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.
- Trial name
- NCT00002194
- Testing
- Erythromycin, Nevirapine, Clarithromycin
- Where
- United States
- Volunteers
- 36 people
- Sponsor
- Boehringer Ingelheim
HIV Infections
Nevirapine vs. Atazanavir Boosted With Ritonavir on a Background of Truvada in Human Immunodeficiency Virus (HIV) Infected Naive Patients (NEwArT)
The aim of this clinical trial is to compare the efficacy and safety of ritonavir (RTV)-boosted atazanavir with nevirapine, each on a background of emtricitabine and tenofovir disoproxil fumarate (DF).
- Trial name
- NCT00552240
- Testing
- tenofovir DF 300 mg QD, emtricitabine 200 mg QD, Nevirapine 200 mg BID
- Where
- 19 sites in United States
- Volunteers
- 154 people
- Sponsor
- Boehringer Ingelheim
HIV Infections
Observational Study of Nevirapine Extended Release in Human Immunodeficiency Virus (HIV) Patients in Daily Clinical Practice
This Post Marketing Surveillance study will be performed as an open-label, prospective, non-interventional, uncontrolled study in Human immunodeficit Virus-1 (HIV-1) infected patients.
- Trial name
- NCT01524900
- Where
- 53 sites in Austria, Poland and 1 more
- Volunteers
- 398 people
- Sponsor
- Boehringer Ingelheim
HIV Infections, Quality of Life
Quality of Life and Changes in Metabolism of Lipids and Glucose After Switching to a Nevirapine-based Regimen in HIV+ Patients
The purpose of this trial is to compare the effect of switching to nevirapine (Viramune®)-containing regimen on quality of life of patients with fat abnormalities and virological control whilst receiving a PI-based regimen.
- Trial name
- NCT00274001
- Testing
- Nevirapine
- Where
- 24 sites in Italy
- Volunteers
- 158 people
- Sponsor
- Boehringer Ingelheim
Acquired Immunodeficiency Syndrome
A Study of Single Dose Nevirapine (NVP) Combined With Combivir® for the Prevention of Mother to Child Transmission (pMTCT) - Treatment Options Preservation Study (TOPS)
To determine whether a regimen of single dose nevirapine combined with either 4 or 7 days of Combivir®, compared to a regimen of single dose nevirapine, for the prevention of mother to child transmission can reduce the rate of…
- Trial name
- NCT00144183
- Testing
- Nevirapine (NVP), Zidovudine (ZCV), 3TC
- Where
- 5 sites in South Africa
- Volunteers
- 407 people
- Sponsor
- Boehringer Ingelheim
HIV Infections, Hepatic Insufficiency
A Pharmacokinetic Study to Assess Nevirapine [Viramune] Levels in HIV Infected Patients With Impaired Hepatic Functions
The objective of this study was to evaluate the steady-state clearance of nevirapine among HIV-1 positive patients with hepatic fibrosis, and to examine whether the degree of hepatic impairment influences clearance.
- Trial name
- NCT00144248
- Testing
- nevirapine
- Where
- 8 sites in United States, France and 1 more
- Volunteers
- 51 people
- Sponsor
- Boehringer Ingelheim
HIV Infections
Case-Control Viramune (Nevirapine) Toxicogenomics Study
Attempt to identify genetic polymorphisms in interrogated pathways which may be associated with symptomatic hepatotoxicity or severe cutaneous toxicity observed in case patients within the first 8 weeks of nevirapine therapy.
- Trial name
- NCT00310843
- Testing
- Nevirapine
- Where
- 102 sites in United States, Argentina and 9 more
- Volunteers
- 889 people
- Sponsor
- Boehringer Ingelheim
Healthy
Pharmacokinetic Properties of Nevirapine Extended Release Tablets When Administered Orally in Healthy Male Volunteers
Study to determine the pharmacokinetic properties of 200 mg nevirapine (NVP) administered as 4 x 50 mg extended release (XR) tablets in a single dose and to establish the bioequivalence of this formulation compared to 200 mg NVP…
- Trial name
- NCT02194218
- Testing
- Nevirapine, low dose, Nevirapine, high dose
- Volunteers
- 48 people, healthy volunteers welcome
- Sponsor
- Boehringer Ingelheim
HIV Infections
Non-interventional Observational Study With Viramune (Nevirapine) and Various Drug Combinations in the Antiretroviral Combination Treatment of HIV-infected Patients Who Have Already Been Treated for Approx. 10 Years With Viramune
The question that prompted this study is the extent to which results from clinical trials can be translated into everyday practice (external validity).
- Trial name
- NCT00979420
- Where
- 60 sites in Germany
- Sponsor
- Boehringer Ingelheim
HIV Infections
Observational Non-interventional Study With Viramune® in Combination With Truvada® in HIV-infected Patients
This observational study is supposed to assess (under conditions of clinical practice in daily routine) whether treatment with Viramune (nevirapine) in combination with Truvada (tenofovir and emtricitabine) will durably suppress…
- Trial name
- NCT00543803
- Where
- 63 sites in Germany
- Volunteers
- 334 people
- Sponsor
- Boehringer Ingelheim
HIV Infections
The Safety and Effectiveness of Retrovir Plus HIVID Combined With Either Nevirapine or Invirase in the Treatment of HIV Infection
To evaluate the tolerance and immunologic and virologic effects of multidrug combinations of antiretrovirals in patients with HIV infection.
- Trial name
- NCT00002347
- Testing
- Saquinavir, Nevirapine, Zidovudine
- Where
- United States
- Volunteers
- 225 people
- Sponsor
- Parexel