Clinical Trials

Numerous clinical trials evaluate Nevirapine across Phase 1 through Phase 4 studies, focusing on HIV/AIDS management, perinatal transmission prevention, tuberculosis co-infections, and pharmacokinetic profiles in healthy volunteers. Featuring recruitment statuses spanning active, recruiting, completed, terminated, and unknown, these trials assess diverse therapeutic regimens. Research sponsors include commercial entities such as Boehringer Ingelheim alongside government and academic organizations, including the National Institute of Allergy and Infectious Diseases (NIAID) and ANRS.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT02140255 RECRUITING
HIV Infection
National Institute of Allergy and Infectious Diseases (NIAID)
 2015-01-23 PHASE1; PHASE2
NCT05725252 Completed
Healthy Volunteers
NVP Healthcare
 2023-05-28 Phase 1
NCT07014189 COMPLETED
HIV Infection; Antiretroviral Treatment; Maintenance Therapy
Cantonal Hospital of St. Gallen
 2019-04-12 PHASE4
NCT05354713 Completed
Healthy Volunteers
NVP Healthcare
 2022-11-05 Phase 1
NCT03088410 COMPLETED
HIV; Insulin Sensitivity; Diabetes Mellitus
Ann & Robert H Lurie Children's Hospital of Chicago
 2016-08-22 PHASE4
NCT02712801 COMPLETED
HIV/AIDS and Infections
National Center for Women and Children's Health, China CDC
 2016-04 PHASE4
NCT04926727 Unknown status
Nausea Gravidarum|Vomiting of Pregnancy
Italfarmaco|Opera CRO a TIGERMED Group Company
 2021-10-04 --
NCT02369406 ACTIVE_NOT_RECRUITING
HIV; Pediatric AIDS
Harvard School of Public Health (HSPH)
 2015-05-04 PHASE2; PHASE3
NCT02431975 COMPLETED
HIV
Columbia University
 2015-08 PHASE4
NCT00872872 COMPLETED
NVP Plasma Level; NVP Related Mutation; 3TC Related Mutation
Thai Red Cross AIDS Research Centre
 2008-05
NCT03223402 COMPLETED
HIV Infections
Cantonal Hospital of St. Gallen
 2016-12-23
NCT03664440 COMPLETED
Efficacy of Rilpivirine-based Regimens as Switch Therapy
Mahidol University
 2016-12-01
NCT01637558 COMPLETED
Tuberculosis; HIV
University of Cape Town
 2012-11 PHASE4
NCT02116660 TERMINATED
HIV Infections
Merck Sharp & Dohme LLC
 2014-09-03 PHASE2
NCT01061151 COMPLETED
HIV Infections
National Institute of Allergy and Infectious Diseases (NIAID)
 2011-03-01 PHASE3
NCT02738502 Completed
Maternal-fetal Infection Transmission
ANRS Emerging Infectious Diseases|Institut National de la Santé Et de la Recherche Médicale France
 2016-07-06 Phase 2
NCT01632891 COMPLETED
HIV-1 Infection; Pf Subclinical Parasitemia
Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections
 2014-01-10 PHASE1; PHASE2
NCT02104700 COMPLETED
HIV
Philip Grant
 2014-04 PHASE2; PHASE3
NCT02067767 COMPLETED
HIV-1 Infection
Nantes University Hospital
 2014-02 PHASE2
NCT02383849 Completed
Low-Birth-Weight Infant|Tuberculosis|HIV
International Maternal Pediatric Adolescent AIDS Clinical Trials Group|National Institute of Allergy and Infectious Diseases (NIAID)|Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
 2015-08-04 --
NCT02202005 COMPLETED
HIV-1
Ratiopharm GmbH
 2014-08 PHASE1
NCT01511237 COMPLETED
HIV Infections
Institut de Recherche pour le Developpement
 2011-12 PHASE3
NCT00074581 COMPLETED
HIV Infections
National Institute of Allergy and Infectious Diseases (NIAID)
 2005-02 PHASE3
NCT01789879 COMPLETED
HIV; Contraception
University of Nebraska
 2014-03-04 PHASE2
NCT01192035 COMPLETED
HIV-1
University of Aarhus
 2011-05 PHASE4
NCT01340950 COMPLETED
HIV Infections; Central Nervous System Diseases; Dementia
University of California, San Diego
 2010-07 PHASE4
NCT00719602 COMPLETED
HIV Infections; Malaria
International Maternal Pediatric Adolescent AIDS Clinical Trials Group
 2009-08 EARLY_PHASE1
NCT00978068 COMPLETED
Malaria; HIV Infections
University of California, San Francisco
 2009-09 PHASE3
NCT01805258 COMPLETED
HIV/TB Co-infection
All India Institute of Medical Sciences
 2007-06 PHASE3
NCT00540137 COMPLETED
HIV Infections
Imperial College London
 2007-07 PHASE4
NCT01562886 COMPLETED
HIV
Imperial College London
 2012-03 PHASE1
NCT00885287 COMPLETED
Malaria, Falciparum; HIV Infections
University of Copenhagen
 2009-07 PHASE4
NCT00905489 COMPLETED
HIV Infections
Boehringer Ingelheim
 2009-06 PHASE1
NCT00102960 COMPLETED
HIV Infections
National Institute of Allergy and Infectious Diseases (NIAID)
 2005-07 PHASE3
NCT01277627 UNKNOWN
HCV Infection.; HCV Viral Load.
Valme University Hospital
 2011-01
NCT00986063 COMPLETED
Nevirapine Induced Rash; Nevirapine Induced Hepatitis; HIV; Adverse Side Effects; AIDS; HIV Infections
Surakameth Mahasirimongkol
 2009-07 PHASE4
NCT01187719 COMPLETED
HIV-infection; Pregnancy; Mother to Child Transmission
Radboud University Medical Center
 2010-05 PHASE2
NCT00819052 COMPLETED
HIV Infections
Boehringer Ingelheim
 2008-12 PHASE3
NCT01042652 UNKNOWN
HIV; HIV Infections
Centers for Disease Control and Prevention, China
 2011-02
NCT00561925 COMPLETED
HIV Infections
Boehringer Ingelheim
 2007-11 PHASE3
NCT01469520 UNKNOWN
HIV; AIDS
Elim Pediatric Pharmaceuticals Inc.
 2010-10 PHASE1
NCT01772940 COMPLETED
HIV-1 Infection
Centre Hospitalier Universitaire Saint Pierre
 2008-12 PHASE4
NCT00074412 COMPLETED
HIV Infections
National Institute of Allergy and Infectious Diseases (NIAID)
 2007-01 PHASE3
NCT00234091 COMPLETED
HIV Infections
National Institute of Allergy and Infectious Diseases (NIAID)
 2006-04 PHASE3
NCT00620438 UNKNOWN
HIV Infections; Tuberculosis
Makerere University
 2008-02 PHASE4
NCT00573001 COMPLETED
HIV Infections
French National Agency for Research on AIDS and Viral Hepatitis
 2008-07 PHASE3
NCT00495326 COMPLETED
Tuberculosis; Aids; Hiv Infections
French National Agency for Research on AIDS and Viral Hepatitis
 2007-12 PHASE2; PHASE3
NCT00099359 COMPLETED
Disease Transmission, Vertical; Vertical Human Immunodeficiency Virus Transmission; HIV Infections
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
 2004-02 PHASE3
NCT00389207 COMPLETED
HIV Infections
Boehringer Ingelheim
 2006-10 PHASE3
NCT00307151 COMPLETED
HIV Infections
International Maternal Pediatric Adolescent AIDS Clinical Trials Group
 2005-12 PHASE2
NCT00409591 TERMINATED
HIV Infections; Pregnancy
Institut de Recherche pour le Developpement
 2008-07 PHASE3
NCT00346567 COMPLETED
HIV Infections
Rigshospitalet, Denmark
 2006-06
NCT00640887 COMPLETED
HIV Infections; Tuberculosis
French National Agency for Research on AIDS and Viral Hepatitis
 2009-02 PHASE2
NCT00089505 COMPLETED
HIV Infections
Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections
 2006-11 PHASE3
NCT00910806 COMPLETED
HIV Infections
Tibotec BVBA
 2009-06 PHASE1
NCT00099632 COMPLETED
HIV Infections
National Institute of Allergy and Infectious Diseases (NIAID)
 2006-03 PHASE2
NCT00552240 COMPLETED
HIV Infections
Boehringer Ingelheim
 2007-09 PHASE4
NCT00001644 COMPLETED
HIV Infection
National Institute of Allergy and Infectious Diseases (NIAID)
 1997-03-03 PHASE1
NCT00164736 COMPLETED
HIV Infections
Centers for Disease Control and Prevention
 2004-03 PHASE3
NCT00672412 COMPLETED
HIV Infections
National Institute of Allergy and Infectious Diseases (NIAID)
 2008-10 PHASE1; PHASE2
NCT00703898 COMPLETED
HIV Infections
Bamrasnaradura Infectious Diseases Institute
 2004-11 PHASE4
NCT00307502 COMPLETED
HIV Infections
Germans Trias i Pujol Hospital
 2005-01 PHASE1
NCT02194218 COMPLETED
Healthy
Boehringer Ingelheim
 2009-09 PHASE1
NCT00294892 COMPLETED
HIV Infections
Radboud University Medical Center
 2006-02 PHASE2
NCT00790881 COMPLETED
Malaria; HIV
University of Cape Town
 2008-10 PHASE4
NCT00617643 COMPLETED
HIV Infections; Tuberculosis
Makerere University
 2008-05 PHASE4
NCT00332306 UNKNOWN
Tuberculosis; Human Immunodeficiency Virus Infections
Tuberculosis Research Centre, India
 2006-06 PHASE3
NCT00427297 TERMINATED
HIV Infections
University of Washington
 2007-09 PHASE3
NCT00260078 COMPLETED
HIV Infections
National Institute of Allergy and Infectious Diseases (NIAID)
 2006-02 PHASE1; PHASE2
NCT00270296 COMPLETED
HIV Infections
National Institute of Allergy and Infectious Diseases (NIAID)
 2006-06 PHASE2
NCT00255840 COMPLETED
HIV Infections
CIPRA SA
 2006-07
NCT00146380 COMPLETED
HIV Infections
Centers for Disease Control and Prevention
 2003-07 PHASE2
NCT00483054 COMPLETED
HIV Infections; Tuberculosis
Bamrasnaradura Infectious Diseases Institute
 2007-01 PHASE3
NCT00661349 TERMINATED
HIV Infections
Germans Trias i Pujol Hospital
 2008-02 PHASE4
NCT00830856 COMPLETED
Cryptococcal Meningitis; HIV Infections
University of Zimbabwe
 2006-10
NCT00109590 COMPLETED
HIV Infections
National Institute of Allergy and Infectious Diseases (NIAID)
 2006-06 PHASE2
NCT00476853 COMPLETED
HIV Infections; Tuberculosis
The HIV Netherlands Australia Thailand Research Collaboration
 2005-10 PHASE2
NCT00312091 COMPLETED
HIV Infections
National Institute of Allergy and Infectious Diseases (NIAID)
 2006-12 PHASE1; PHASE2
NCT02184312 COMPLETED
Healthy
Boehringer Ingelheim
 2008-04 PHASE1
NCT00704249 COMPLETED
HIV Infections
Clinical Trial Agency of HIV Study Group
 2006-07 PHASE4
NCT00344461 COMPLETED
HIV
University of Maryland, Baltimore
 2004-03 PHASE4
NCT00523458 TERMINATED
HIV Infections; Tuberculosis
Stanford University
 2007-07 PHASE4
NCT00355719 COMPLETED
HIV Infections
Germans Trias i Pujol Hospital
 2007-01 PHASE4
NCT00143689 COMPLETED
HIV; Mitochondrial Toxicity
University of British Columbia
 2002-04 PHASE4
NCT00115648 COMPLETED
HIV Infections
Johns Hopkins Bloomberg School of Public Health
 2004-04 PHASE3
NCT00639938 COMPLETED
HIV Infections
National Institute of Allergy and Infectious Diseases (NIAID)
 2004-07 PHASE3
NCT00455585 COMPLETED
HIV Infections
Makerere University
 2007-01 PHASE4
NCT02194179 COMPLETED
HIV Infections
Boehringer Ingelheim
 2006-12 PHASE1
NCT00204308 COMPLETED
HIV; Pregnancy
University of North Carolina, Chapel Hill
 2005-03 PHASE2
NCT00074399 COMPLETED
HIV Infections
National Institute of Allergy and Infectious Diseases (NIAID)
 2001-02 PHASE3
NCT00061321 COMPLETED
HIV Infections
National Institute of Allergy and Infectious Diseases (NIAID)
 2002-08 PHASE3
NCT00144183 COMPLETED
Acquired Immunodeficiency Syndrome
Boehringer Ingelheim
 2003-01 PHASE3
NCT00144261 COMPLETED
HIV Infections; Metabolism, Lipids
Boehringer Ingelheim
 2003-11-01 PHASE4
NCT00192660 COMPLETED
HIV-Associated Lipodystrophy Syndrome; Cardiovascular Disease
Kirby Institute
 2003-02 PHASE4
NCT00618176 COMPLETED
HIV Infections
Peking Union Medical College
 2005-01 PHASE4
NCT02192463 COMPLETED
Healthy
Boehringer Ingelheim
 2006-04 PHASE1
NCT00415090 COMPLETED
HIV Infections
Hospital de Calella
 2004-08 PHASE4
NCT00162149 COMPLETED
HIV Infections
Bristol-Myers Squibb
 2005-10 PHASE1
NCT00144157 COMPLETED
Acquired Immunodeficiency Syndrome
Boehringer Ingelheim
 2003-06 PHASE4
NCT00144248 COMPLETED
HIV Infections; Hepatic Insufficiency
Boehringer Ingelheim
 2004-06-25 PHASE4
NCT01025830 COMPLETED
HIV/AIDS
Makerere University
 2006-02 PHASE4
NCT00142337 COMPLETED
HIV Infections
Institut de Recherche pour le Developpement
 2004-12 PHASE2
NCT00730223 COMPLETED
HIV Infections
Vanderbilt University
 2004-03 PHASE1
NCT00335686 COMPLETED
HIV Infections
Germans Trias i Pujol Hospital
 2003-10 PHASE4
NCT02191189 COMPLETED
Healthy
Boehringer Ingelheim
 2005-05 PHASE1
NCT00197587 COMPLETED
HIV Infection; Infant Risk for HIV Infection by MTCT
Harvard School of Public Health (HSPH)
 2002-08
NCT00167674 COMPLETED
HIV Infections
University of Washington
 2003-11-03 PHASE2
NCT00273975 COMPLETED
HIV Infections
Boehringer Ingelheim
 2002-01 PHASE2
NCT00274001 COMPLETED
HIV Infections; Quality of Life
Boehringer Ingelheim
 2001-09 PHASE4
NCT00273988 COMPLETED
Acquired Immunodeficiency Syndrome
Boehringer Ingelheim
 2002-04 PHASE4
NCT00000922 COMPLETED
HIV Infections
National Institute of Allergy and Infectious Diseases (NIAID)
NCT00021463 COMPLETED
HIV Infections; Lipodystrophy
National Institute of Allergy and Infectious Diseases (NIAID)
 PHASE2
NCT02181946 COMPLETED
HIV Infections
Boehringer Ingelheim
 2001-05 PHASE4
NCT02182765 TERMINATED
HIV Infections
Boehringer Ingelheim
 1999-04 PHASE1
NCT02181933 COMPLETED
HIV Infections
Boehringer Ingelheim
 1999-04 PHASE3
NCT02184286 TERMINATED
HIV Infections
Boehringer Ingelheim
 1999-05 PHASE1
NCT02184299 COMPLETED
HIV Infections
Boehringer Ingelheim
 1999-04 PHASE4
NCT02184091 COMPLETED
Renal Insufficiency; Hepatic Insufficiency
Boehringer Ingelheim
 1999-01 PHASE1
NCT02182791 COMPLETED
HIV Infections
Boehringer Ingelheim
 1998-04 PHASE1
NCT02184078 COMPLETED
HIV Infections
Boehringer Ingelheim
 1998-10 PHASE4
NCT00000634 COMPLETED
HIV Infections
National Institute of Allergy and Infectious Diseases (NIAID)
NCT00001111 COMPLETED
HIV Infections
National Institute of Allergy and Infectious Diseases (NIAID)
NCT00000747 COMPLETED
HIV Infections
National Institute of Allergy and Infectious Diseases (NIAID)
 PHASE2
NCT00004581 COMPLETED
HIV Infections
Abbott
 PHASE3
NCT00021671 COMPLETED
HIV Infections
National Institute of Allergy and Infectious Diseases (NIAID)
 PHASE3
NCT00000895 COMPLETED
Mycobacterium Avium-intracellulare Infection; HIV Infections
National Institute of Allergy and Infectious Diseases (NIAID)
NCT00197613 COMPLETED
AIDS; HIV Infection
Harvard School of Public Health (HSPH)
 2002-12 PHASE3
NCT00004855 COMPLETED
HIV Infections
National Institute of Allergy and Infectious Diseases (NIAID)
NCT00000872 COMPLETED
HIV Infections
National Institute of Allergy and Infectious Diseases (NIAID)
 PHASE2
NCT00000814 COMPLETED
HIV Infections
National Institute of Allergy and Infectious Diseases (NIAID)
 PHASE1
NCT00000962 COMPLETED
HIV Infections
National Institute of Allergy and Infectious Diseases (NIAID)
 PHASE1
NCT00002166 COMPLETED
HIV Infections
Boehringer Ingelheim
 PHASE3
NCT00122226 UNKNOWN
HIV Infections; HIV-Associated Lipodystrophy Syndrome
Amsterdam UMC, location VUmc
 2003-01 PHASE4
NCT00006396 COMPLETED
HIV Infections
National Institute of Allergy and Infectious Diseases (NIAID)
 PHASE3
NCT00398684 COMPLETED
HIV Infections; Pregnancy
Institut de Recherche pour le Developpement
 2001-01 PHASE3
NCT00000770 COMPLETED
HIV Infections
National Institute of Allergy and Infectious Diseases (NIAID)
 PHASE2
NCT00002407 COMPLETED
HIV Infections
Weill Medical College of Cornell University
NCT00000649 COMPLETED
HIV Infections
Boehringer Ingelheim
 PHASE1
NCT00002368 COMPLETED
HIV Infections
Boehringer Ingelheim
 PHASE3
NCT00000869 COMPLETED
HIV Infections; Pregnancy
National Institute of Allergy and Infectious Diseases (NIAID)
 PHASE3
NCT00466180 COMPLETED
HIV Infections
University Hospital, Caen
 2004-06 PHASE4
NCT00000902 COMPLETED
HIV Infections
National Institute of Allergy and Infectious Diseases (NIAID)
 PHASE1
NCT00004580 COMPLETED
HIV Infections
Abbott
 PHASE1
NCT00002194 COMPLETED
HIV Infections
Boehringer Ingelheim
 PHASE1
NCT00117728 UNKNOWN
AIDS; HIV Infections
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
 2005-04 PHASE3
NCT00087464 WITHDRAWN
HIV Infections
National Institute of Allergy and Infectious Diseases (NIAID)
NCT00405171 COMPLETED
HIV Infections; Hypercholesterolemia; Antiretroviral Therapy
University Hospital, Caen
 2003-06 PHASE4
NCT00017719 COMPLETED
HIV Infections; Pregnancy
National Institute of Allergy and Infectious Diseases (NIAID)
 2002-05 PHASE3
NCT00000808 COMPLETED
HIV Infections; Pregnancy
National Institute of Allergy and Infectious Diseases (NIAID)
 PHASE1
NCT00127972 COMPLETED
HIV Infections
International Antiviral Therapy Evaluation Center
 2004-02 PHASE4
NCT00001135 COMPLETED
HIV Infections; Pregnancy
National Institute of Allergy and Infectious Diseases (NIAID)
 PHASE3
NCT00001091 COMPLETED
HIV Infections
National Institute of Allergy and Infectious Diseases (NIAID)
 PHASE1
NCT00001083 COMPLETED
HIV Infections
National Institute of Allergy and Infectious Diseases (NIAID)
 PHASE2
NCT00002324 COMPLETED
HIV Infections
Boehringer Ingelheim
 PHASE2
NCT00028314 COMPLETED
HIV Infections; Lipodystrophy; Wasting Disease
National Institute of Allergy and Infectious Diseases (NIAID)
 2002-03
NCT00001045 COMPLETED
HIV Infections
National Institute of Allergy and Infectious Diseases (NIAID)
 PHASE2
NCT00000896 COMPLETED
HIV Infections
National Institute of Allergy and Infectious Diseases (NIAID)
NCT00001095 COMPLETED
HIV Infections
National Institute of Allergy and Infectious Diseases (NIAID)
 PHASE2
NCT00000924 COMPLETED
HIV Infections
National Institute of Allergy and Infectious Diseases (NIAID)
 PHASE2
NCT00000942 COMPLETED
HIV Infections; Pregnancy
National Institute of Allergy and Infectious Diseases (NIAID)
 PHASE3
NCT00002323 COMPLETED
HIV Infections
Boehringer Ingelheim
NCT00000781 COMPLETED
HIV Infections
National Institute of Allergy and Infectious Diseases (NIAID)
 PHASE2
NCT00002347 COMPLETED
HIV Infections
Parexel
 PHASE2
NCT00001108 COMPLETED
HIV Infections
National Institute of Allergy and Infectious Diseases (NIAID)
 PHASE1
NCT00002418 TERMINATED
HIV Infections
Bristol-Myers Squibb
 PHASE2
NCT00006279 COMPLETED
HIV Infections
National Institute of Allergy and Infectious Diseases (NIAID)
 PHASE1
NCT00013520 COMPLETED
HIV Infections
National Institute of Allergy and Infectious Diseases (NIAID)
 PHASE3
NCT00199979 UNKNOWN
Hiv Infection With Antiretroviral Therapy Indication; CD4 Below 350/µL or Below 15%
MEDEX
 2005-04 PHASE3
NCT00001688 COMPLETED
HIV Infection
National Cancer Institute (NCI)
 1998-01 PHASE2
NCT00002381 COMPLETED
HIV Infections
Boehringer Ingelheim
 PHASE1
NCT00016601 COMPLETED
HIV Infections
National Institute of Allergy and Infectious Diseases (NIAID)
 2001-06

(data from https://clinicaltrials.gov, updated on 2026-08-19)

Check the Nevirapine (NSC 641530) product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

Nevirapine directly binds to an allosteric pocket adjacent to the catalytic site of HIV-1 reverse transcriptase, inhibiting both RNA-dependent and DNA-dependent DNA polymerase activities essential for viral genome copying. This blockade halts the synthesis of proviral DNA and prevents the integration of viral genetic material into the host genome, thereby suppressing viral replication to manage HIV-1 infections and prevent maternal-fetal transmission.

Appendix RUO and cGMP Quality Standards

Quality Dimension RUO (Research Use Only) cGMP (Current Good Manufacturing Practice)
Clinical Applicability Prohibited in human clinical trials or medical diagnostics. Mandatory for human clinical trials (Phase I–III) and therapies.
Regulatory Status Non-regulated grade; exempt from drug manufacturing laws. Legally enforced by health authorities (e.g., FDA, EMA, NMPA).
Facility Environment Unclassified analytical or research laboratories. Validated Cleanrooms (ISO Class 5–8) with continuous monitoring.
Quality Control Basic purity and activity testing. Rigorous safety release testing (Sterility, Endotoxin, Mycoplasma).
Process Validation Basic equipment calibration; no process validation required. Full qualification (IQ/OQ/PQ) and complete batch records.
Quality Assurance Vendor self-declared without required formal QMS. Mandatory QA/QC unit, Change Control, CAPA, and vendor audits.
Regulatory Impact High risk of IND rejection if used as a critical raw material. Required for IND/NDA filings, supported by Drug Master Files (DMF).

Footnotes

Regulatory Note: Governed by FDA (21 CFR Parts 210/211/312), EMA (EudraLex Vol 4), ICH Guidelines (E6/Q7/Q9/Q10), and compendial standards (USP <71>/<85>/<1043>).

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Note: Technical data last updated: Sep 1, 2026.