Drugs / Nevirapine
last change Dec 2024 re-read 9 days ago

Nevirapine

Small molecule

Developed for
HIV infectious disease · tuberculosis · AIDS · lipodystrophy · HIV wasting syndrome · hyperlipoproteinemia · Kaposi's sarcoma · central nervous system disorder
+2 more · dementia · hepatitis C virus infection
Investigated by
National Institute of Allergy and Infectious Diseases (NIAID) · Boehringer Ingelheim · Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) · Bristol-Myers Squibb · Harvard School of Public Health (HSPH) · French National Agency for Research on AIDS and Viral Hepatitis
+85 more · National Institute of Mental Health (NIMH) · Glaxo Wellcome · International Maternal Pediatric Adolescent AIDS Clinical Trials Group · Makerere University · AIDS Care Research in Africa · ANRS, Emerging Infectious Diseases · Abbott · Bamrasnaradura Infectious Diseases Institute · Centers for Disease Control and Prevention · Fight AIDS and Infectious Diseases Foundation · Germans Trias i Pujol Hospital · Gilead Sciences · Merck Sharp & Dohme LLC · National AIDS Control Organisation · National Institute on Drug Abuse (NIDA) · Research Institute for Development · University of California, San Diego · AIDS Malignancy Consortium · Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections · All India Institute of Medical Sciences · Amsterdam UMC, location VUmc · Ann & Robert H Lurie Children's Hospital of Chicago · Botswana Harvard Health Partnership · Botswana Ministry of Health · Brigham and Women's Hospital · CIHR Canadian HIV Trials Network · Chulalongkorn University · Cipla Medpro · Columbia University · Department of Foreign Affairs, Ireland · Dermatological Society of South Africa · Doris Duke Charitable Foundation · Guangdong Provincial Maternal and Child Health Hospital · HIV Prevention Trials Network · Health Research Board, Ireland · Hospital San Jaime de Calella · Hospital de Calella · Indian Council of Medical Research · Institut de Médecine et d'Epidémiologie Appliquée - Fondation Internationale Léon M'Ba · International Antiviral Therapy Evaluation Center · Johns Hopkins Bloomberg School of Public Health · Kirby Institute · Liverpool School of Tropical Medicine · MEDEX · Mahidol University · Maternal and Child Health Hospital of Guangxi Province · Maternal and Child Health Hospital of Sichuan Province · Maternal and Child Health Hospital of Xinjiang Uygur Autonomous Region · Maternal and Child Health Hospital of Yunan Province · McGill University Health Centre/Research Institute of the McGill University Health Centre · Medecins Sans Frontieres, Netherlands · Ministry of Science and Technology of the People´s Republic of China · National Cancer Institute (NCI) · National Center for AIDS/STD Control and Prevention, China CDC · National Center for Women and Children's Health, China CDC · National Heart, Lung, and Blood Institute (NHLBI) · National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) · National Institutes of Health (NIH) · National Research Foundation, Singapore · PENTA Foundation · Parexel · Peking Union Medical College · Princess Marina Hospital, Botswana · Ragon Institute of MGH, MIT and Harvard · Ratiopharm GmbH · Roxane Laboratories · St Vincent's Hospital, Sydney · Stanford University · Tibotec BVBA · Triangle Pharmaceuticals · Tuberculosis Research Centre, India · University Hospital, Caen · University of British Columbia · University of Cape Town · all 91 on the full record

Regulatory milestones approvals, filings & regulatory actions · 7 recorded

MilestoneJurisdictionBrandIndicationDateSentence it was read from
Label expansion US (FDA) VIRAMUNE XR — 2012-09-28 fda.gov ↗
Label expansions (4) US (FDA) VIRAMUNE — 1998-05-20 – 2008-06-24 fda.gov ↗
Approved EU (EMA) Viramune — 1998-02-04 europa.eu ↗
Approved US (FDA) VIRAMUNE — 1996-06-21 fda.gov ↗

Trials 126 · started per year

today
US approved 1996
EU approved 1998
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PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 125 trials
Phase 1 NCT02202005 Aug 2014 → Jul 2015 — Ratiopharm GmbH Completed No outcome recorded
Phase 1 NCT02194218 Sep → Nov 2009 — Boehringer Ingelheim Completed No outcome recorded
Phase 1 NCT00910806 Jun 2009 → Jun 2010 HIV infectious disease Tibotec BVBA Completed No outcome recorded
Phase 1 NCT00905489 Jun 2009 → Sep 2012 HIV infectious disease Boehringer Ingelheim Completed No outcome recorded
Phase 1 NCT02184312 Apr → Jul 2008 — Boehringer Ingelheim Completed No outcome recorded
Phase 1 NCT02194179 Dec 2006 → May 2007 HIV infectious disease Boehringer Ingelheim Completed No outcome recorded
Phase 1 NCT02192463 Apr → Aug 2006 — Boehringer Ingelheim Completed No outcome recorded
Phase 1 NCT02191189 May 2005 → Jan 2006 — Boehringer Ingelheim Completed No outcome recorded
Phase 1 NCT00307502 Jan 2005 → Dec 2009 HIV infectious disease Germans Trias i Pujol Hospital Completed No outcome recorded
Phase 1 NCT00730223 Mar 2004 → Mar 2006 HIV infectious disease Vanderbilt University Completed No outcome recorded
Phase 1/24 trials
Phase 1/2 NCT02140255 Jan 2015 → Jan 2028 expected HIV infectious disease National Institute of Allergy and Infectious Diseases (NIAID) Recruiting No outcome recorded
Phase 1/2 NCT00672412 Oct 2008 → Jan 2010 HIV infectious disease National Institute of Allergy and Infectious Diseases (NIAID) Completed No outcome recorded
Phase 1/2 NCT00312091 Dec 2006 → Sep 2008 HIV infectious disease National Institute of Allergy and Infectious Diseases (NIAID) Completed No outcome recorded
Phase 1/2 NCT00260078 Feb 2006 → Apr 2009 HIV infectious disease National Institute of Allergy and Infectious Diseases (NIAID) Completed No outcome recorded
Phase 220 trials · 2 met primary
Phase 2 NCT02116660 Sep 2014 → Jul 2017 HIV infectious disease Merck Sharp & Dohme LLC Terminated No outcome recorded Stop: Enrollment
Phase 2 NCT00640887 Feb 2009 → Oct 2010 HIV infectious disease, tuberculosis French National Agency for Research on AIDS and Viral Hepatitis Completed No outcome recorded
Phase 2 NCT00109590 Jun 2006 → Oct 2008 HIV infectious disease National Institute of Allergy and Infectious Diseases (NIAID) Completed No outcome recorded
Phase 2 NCT00270296 Jun 2006 → Mar 2009 HIV infectious disease National Institute of Allergy and Infectious Diseases (NIAID) Completed No outcome recorded
Phase 2 NCT00307151 Dec 2005 → Dec 2010 HIV infectious disease International Maternal Pediatric Adolescent AIDS Clinical Trials Group Completed Met primary
Phase 2 NCT00146380 Jul 2003 → Jan 2009 HIV infectious disease Centers for Disease Control and Prevention Completed No outcome recorded
Phase 2 NCT00273975 Jan 2002 → Dec 2004 HIV infectious disease Boehringer Ingelheim Completed No outcome recorded
Phase 2 NCT00001688 Jan 1998 → Nov 2001 HIV infectious disease National Cancer Institute (NCI) Completed No outcome recorded
Phase 2 NCT00000781 ? → Sep 1996 HIV infectious disease National Institute of Allergy and Infectious Diseases (NIAID) Completed No outcome recorded
Phase 2 NCT00001095 ? → Oct 1999 HIV infectious disease National Institute of Allergy and Infectious Diseases (NIAID) Completed No outcome recorded
Phase 2/34 trials · 3 missed
Phase 2/3 NCT02369406 May 2015 → Nov 2020 overdue AIDS Harvard School of Public Health (HSPH) Active not recruiting No outcome recorded
Phase 2/3 NCT00495326 Dec 2007 → Apr 2011 AIDS, tuberculosis French National Agency for Research on AIDS and Viral Hepatitis Completed Missed primary
Phase 2/3 NCT00624195 Mar 2007 → Feb 2012 HIV infectious disease University of California, San Diego Completed Missed primary
Phase 2/3 NCT00039741 Aug 2002 → Aug 2009 HIV infectious disease National Institute of Allergy and Infectious Diseases (NIAID) Completed Missed primary
Phase 332 trials · 10 met primary · 7 missed
Phase 3 NCT01511237 Dec 2011 → Jun 2015 HIV infectious disease Research Institute for Development Completed No outcome recorded
Phase 3 NCT00819052 Dec 2008 → Jan 2012 HIV infectious disease Boehringer Ingelheim Completed No outcome recorded
Phase 3 NCT00573001 Jul 2008 → Jul 2011 HIV infectious disease French National Agency for Research on AIDS and Viral Hepatitis Completed No outcome recorded
Phase 3 NCT00561925 Nov 2007 → Nov 2011 HIV infectious disease Boehringer Ingelheim Completed Met primary
Phase 3 NCT00427297 Sep 2007 → May 2009 HIV infectious disease University of Washington Terminated No outcome recorded
Phase 3 NCT01805258 Jun 2007 → Dec 2012 tuberculosis All India Institute of Medical Sciences Completed Missed primary
Phase 3 NCT00483054 Jan 2007 → Dec 2008 HIV infectious disease, tuberculosis Bamrasnaradura Infectious Diseases Institute Completed No outcome recorded
Phase 3 NCT00074412 Jan 2007 → Sep 2011 HIV infectious disease National Institute of Allergy and Infectious Diseases (NIAID) Completed Met primary
Phase 3 NCT00089505 Nov 2006 → Aug 2010 HIV infectious disease Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections Completed Met primary
Phase 3 NCT00332306 Jun 2006 → Jun 2009 HIV infectious disease, tuberculosis Tuberculosis Research Centre, India Unknown No outcome recorded
Phase 430 trials · 2 met primary
Phase 4 NCT06337032 Aug 2024 → Mar 2034 expected HIV infectious disease Gilead Sciences Recruiting No outcome recorded
Phase 4 NCT03642704 Feb 2017 → Sep 2019 — ANRS, Emerging Infectious Diseases Completed No outcome recorded
Phase 4 NCT03088410 Aug 2016 → Mar 2022 HIV infectious disease, diabetes mellitus Ann & Robert H Lurie Children's Hospital of Chicago Completed No outcome recorded
Phase 4 NCT02712801 Apr 2016 → Dec 2021 HIV infectious disease National Center for Women and Children's Health, China CDC Completed No outcome recorded
Phase 4 NCT01637558 Nov 2012 → Jul 2017 HIV infectious disease, tuberculosis University of Cape Town Completed No outcome recorded
Phase 4 NCT00753324 May 2009 → Jan 2012 HIV infectious disease University of North Carolina, Chapel Hill Completed Met primary
Phase 4 NCT00617643 May 2008 → Jun 2009 HIV infectious disease, tuberculosis Makerere University Completed No outcome recorded
Phase 4 NCT00620438 Feb 2008 → Jul 2011 HIV infectious disease, tuberculosis Makerere University Unknown No outcome recorded
Phase 4 NCT00523458 Jul 2007 → Mar 2008 HIV infectious disease, tuberculosis Stanford University Terminated No outcome recorded Stop: Enrollment
Phase 4 NCT00355719 Jan 2007 → Feb 2008 HIV infectious disease Germans Trias i Pujol Hospital Completed No outcome recorded
Phase not applicable11 trials · 2 missed
— NCT00830856 Oct 2006 → Oct 2008 Cryptococcal meningitis, HIV infectious disease University of Zimbabwe Completed Missed primary
— NCT00028314 Mar 2002 → Mar 2005 HIV wasting syndrome, lipodystrophy National Institute of Allergy and Infectious Diseases (NIAID) Completed No outcome recorded
— NCT00016601 Jun 2001 → May 2004 HIV infectious disease National Institute of Allergy and Infectious Diseases (NIAID) Completed No outcome recorded
— NCT00000922 ? → Jan 2003 HIV infectious disease National Institute of Allergy and Infectious Diseases (NIAID) Completed Missed primary
— NCT00087464 — HIV infectious disease National Institute of Allergy and Infectious Diseases (NIAID) Withdrawn No outcome recorded Stop: Enrollment
— NCT00000896 ? → Oct 2000 HIV infectious disease National Institute of Allergy and Infectious Diseases (NIAID) Completed No outcome recorded
— NCT00002407 — HIV infectious disease Weill Medical College of Cornell University Completed No outcome recorded
— NCT00000895 ? → Aug 2001 HIV infectious disease, Mycobacterium avium complex disease National Institute of Allergy and Infectious Diseases (NIAID) Completed No outcome recorded
— NCT00001111 ? → Jun 1995 HIV infectious disease National Institute of Allergy and Infectious Diseases (NIAID) Completed No outcome recorded
— NCT00000634 ? → Jun 1995 HIV infectious disease National Institute of Allergy and Infectious Diseases (NIAID) Completed No outcome recorded
Comparator or background therapy47 trials
Phase 0 NCT00719602 Comparator Aug 2009 → Aug 2013 HIV infectious disease, malaria International Maternal Pediatric Adolescent AIDS Clinical Trials Group Completed No outcome recorded
Phase 1 NCT00162149 Comparator Oct 2005 → Jul 2006 HIV infectious disease Bristol-Myers Squibb Completed No outcome recorded
Phase 1 NCT00032669 Background Mar 2002 → Apr 2006 HIV infectious disease National Cancer Institute (NCI) Completed No outcome recorded
Phase 1 NCT00004580 Background — HIV infectious disease Abbott Completed No outcome recorded
Phase 1/2 NCT01632891 Background Jan 2014 → Jun 2016 HIV infectious disease, parasitemia Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections Completed Missed primary

News releases announcing trial results or a regulatory action · 2

DateIssuerRelease
2011-04-04 Boehringer Ingelheim Regulatory FDA Approves One-Pill, Once-Daily Viramune® XR™ (nevirapine) Extended-Release Tablets for Use in Combination With Other Antiretroviral Agents for Treatment of HIV-1 Infection in Adults prnewswire.com ↗
2010-07-22 Boehringer Ingelheim Results Study Shows Once-Daily, Extended-Release Formulation of Nevirapine was not Inferior to Twice-Daily VIRAMUNE in Treatment-Naive HIV-1 Infected Patients prnewswire.com ↗
The investigational, extended-release formulation of nevirapine had a similar safety profile to immediate release VIRAMUNE in the trial.

Evidence & citations 20 cited values

Every value below carries the sentence it was read from. 185 sources stand behind the page.

FieldValueCited text
Known as nevirapine “Generic names: Efavirenz/Emtricitabine/Tenofovir, Lamivudine/Zidovudine, Emtricitabine, Lamivudine, Abacavir/Lamivudine, Zidovudine, Abacavir/Lamivudine/Zidovudine,...” NCT00624195 ↗
172

“It may include one or two nucleoside reverse transcriptase inhibitors, such as zidovudine, didanosine, lamuvidine, zalcitabine, stavudine), a non- nucleoside reverse...” NCT00032669 ↗

“Participants who will be enrolled in this trial would keep their previous combined antiretroviral therapy, such as zidovudine or stavudine plus lamivudine plus nevirapine or efavirenz.” NCT02002286 ↗

“The study-treatment were lopinavir/r 100/400mg bid or indinavir/r 100/400mg bid for PI-class, for NNRTI-class, efavirenz or nevirapine and all NRTIs except D4T and DDC at usual dosage.” NCT00122668 ↗

“Triomune® (Cipla, Mumbai) Stavudine 40mg b.d \> 60 kg , 30mg bd \<60kg Lamivudine 150mg b.d \> 50 kg 2mg/kg \< 50 kg Nevirapine 200mg b.d ( 200mg daily for first 2 weeks)” NCT00380770 ↗

“Tenofovir+Emtricitabine+Third agent (Including a non nucleoside reverse transcriptase inhibitor: efavirenz or nevirapine or etravirine or rilpivirine” NCT02302547 ↗

“Baseline regimen of antiretroviral therapy with a NNRTI (efavirenz, nevirapine, or rilpivirine) administered according to the product circular” NCT02397096 ↗

“nevirapine: 15mg/OD if weight ≥ 2500g / 10mg/OD if weight = 2000-2499g / 2mg/kg/OD if weight \< 2000g for 12 weeks in case of HIV-1 infection.” NCT03642704 ↗

“Bioavailability of 2 Different Nevirapine Extended Release Formulations Compared to Viramune® in HIV-1 Infected Subjects” NCT02194179 ↗

“efavirenz (EFV), rilpivirine (RPV), raltegravir (RAL), dolutegravir (DTG), maraviroc (MVC), or nevirapine (NVP)” NCT02469246 ↗

“Allowed unboosted 3rd ARV agents: efavirenz (EFV), raltegravir (RAL), dolutegravir (DTG), or nevirapine (NVP)” NCT02285114 ↗

Show 162 more sources

Known as BI-RG-587 “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” NCT00000747 ↗
3

“Nevirapine (BI-RG-587) has shown in vitro inhibitory activity against HIV-1 reverse transcriptase (RT).” NCT00000962 ↗

“Nevirapine (BI-RG-587) has shown in vitro inhibitory activity against HIV-1 reverse transcriptase” NCT00001111 ↗

“nevirapine (BI-RG-587) plasma levels” NCT00000634 ↗

Known as BIRG 0587 ChEMBL registry synonym — accepted as the source's own label CHEMBL57 ↗
Known as Neviparine “Neviparine (NVP)/ Lamivudine (3TC)” NCT07014189 ↗
Known as Nevirapina ChEMBL registry synonym — accepted as the source's own label CHEMBL57 ↗
Known as Nevirapine anhydrous ChEMBL registry synonym — accepted as the source's own label CHEMBL57 ↗
Known as Nevirapine teva ChEMBL registry synonym — accepted as the source's own label CHEMBL57 ↗
Known as Nevirapinum anhydrous ChEMBL registry synonym — accepted as the source's own label CHEMBL57 ↗
Known as NSC-641530 ChEMBL registry synonym — accepted as the source's own label CHEMBL57 ↗
Known as NVP “The objective was to establish the pharmacokinetic (PK) profile at steady state of two different nevirapine (NVP) extended release (XR) formulations at 300 mg or 400 mg daily...” NCT02194179 ↗
57

“In Pediatric AIDS Clinical Trials Group 377, antiretroviral therapy-experienced children were randomized to 4 treatment arms that included different combinations of stavudine,...” PMID 11372025 ↗ May 2001

“The efficacy and tolerance of switching from zidovudine (ZDV) and lamivudine (3TC) in clinically stable HIV-infected children with incomplete viral suppression to stavudine...” PMID 11840078 ↗ Feb 2002

“The purpose of this study is to see if nevirapine (NVP) or zidovudine (AZT), given to mothers during labor and delivery and to their babies during the first week of life, can...” NCT00006396 ↗

“Patients in Arm B-1 will discontinue their current HAART and will receive a PI and a nonnucleoside reverse transcriptase inhibitor (NNRTI), either lopinavir/ritonavir (LPV/r)...” NCT00028314 ↗

“An open-label phase 1/2 study was designed to assess the safety and trough concentrations of nevirapine (NVP) given once weekly (OW), twice weekly (TW), or once daily (OD) to...” PMID 14657758 ↗ Dec 2003

“Treatment-naive adults were randomized to nevirapine (NVP) or ritonavir-boosted lopinavir (LPV/r) regimens each in combination with tenofovir (TDF)/emtricitabine (FTC) or...” PMID 25028911 ↗ May 2014

“The Effect of Single Dose Carbamazepine on the Pharmacokinetics of Single Dose Nevirapine (Viramune, NVP) and Development of NVP Resistance, PMTCT Program of Moshi, Tanzania (VITA1)” NCT00294892 ↗

“The 7 drugs that will be given in this study are stavudine (d4T), didanosine (ddI), lamivudine (3TC), nelfinavir (NFV), ritonavir (RTV), saquinavir (SQV), and nevirapine (NVP).” NCT00001108 ↗

“Nevirapine (NVP) can be safely and effectively administered once-daily but has not been assessed in human immunodeficiency virus (HIV)-infected patients with tuberculosis (TB).” PMID 21890776 ↗ Oct 2011

“Nevirapine (NVP) resistance emerges in up to 70% of women exposed to single-dose (sd) NVP for prevention of mother-to-child transmission of human immunodeficiency virus (HIV).” PMID 23300238 ↗ Jan 2013

Show 47 more sources

Known as NVP IR “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...” NCT00561925 ↗
Known as NVP XR “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...” NCT00561925 ↗
Known as NVP: nevirapine, Viramune “NVP: nevirapine, Viramune” NCT02028676 ↗
Known as Viramune “An International, Double Blind, Randomized, Phase III Study to Evaluate the Tolerance, Safety, and Effectiveness of Viramune (Nevirapine) in Preventing Clinical AIDS...” NCT00002368 ↗
18

“An Investigation of the Potential Pharmacokinetic Interaction Between Nevirapine (Viramune) and Nelfinavir (Viracept) and the Efficacy of This Combination Therapy in HIV-1...” NCT00002381 ↗

“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...” NCT00274001 ↗

“The Effect of Single Dose Carbamazepine on the Pharmacokinetics of Single Dose Nevirapine (Viramune, NVP) and Development of NVP Resistance, PMTCT Program of Moshi, Tanzania (VITA1)” NCT00294892 ↗

“A Pharmacokinetic Study to Evaluate the Interaction Between Nevirapine (Viramune®) and Methadone in HIV-1 Infected, Opioid-dependent Adults on Stable Methadone Maintenance Therapy” NCT00273988 ↗

“An Open-Label, Non-Randomized Trial to Evaluate the Tolerability and Safety of Viramune (Nevirapine) in Adult and Pediatric Patients With Progressive HIV Disease” NCT00002166 ↗

“An Open-Label Study in HIV+ Patients to Determine the Effects of Nevirapine (Viramune) on the Pharmacokinetics of Clarithromycin and Activity of Cytochrome 3A4.” NCT00002194 ↗

“Study to Determine the Effects of Nevirapine (VIRAMUNE®) on the Steady State Pharmacokinetics of Rifabutin (MYCOBUTIN®) in HIV+ Patients” NCT02184078 ↗

“lopinavir/ritonavir (Kaletra) and nevirapine (Viramune) twice a day;” NCT00143689 ↗

“Nevirapine (Viramune): tablets 200 mg (1 tablet/12h\*)” NCT00355719 ↗

“Nevirapine (Viramune): 1 comp (200mg)/12h” NCT00335686 ↗

Show 8 more sources

Known as Viramune (nevirapine) “Viramune (nevirapine)” NCT00523458 ↗
Known as Viramune (Nevirapine) suspension 50mg/5ml “Viramune (Nevirapine) suspension 50mg/5ml” NCT00164736 ↗
Known as Viramune xr ChEMBL registry synonym — accepted as the source's own label CHEMBL57 ↗
Action Inhibit “Test tube studies have shown that nevirapine (BI-RG-587) inhibits replication (reproduction) of HIV.” NCT00000634 ↗
Modality Small molecule “non-nucleoside reverse transcriptase inhibitor” NCT00000781 ↗
Route Oral “Two doses, given by mouth, are evaluated” NCT00000634 ↗