Numerous clinical trials evaluate raltegravir across Early Phase 1 through Phase 4 post-marketing studies, primarily focusing on HIV-1 and HIV-2 management, Hepatitis C coinfections, and evaluations in healthy volunteers. Conducted by pharmaceutical leaders like Merck Sharp & Dohme LLC alongside academic sponsors such as ANRS Emerging Infectious Diseases, these trials encompass statuses ranging from recruiting and completed to terminated or approved for marketing. Key investigations assess dual maintenance regimens, pharmacokinetics, safety, and drug interactions across diverse patient populations.
| 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 |
| NCT04513626 | RECRUITING | HIV Infections |
Centre de Recherches et d'Etude sur la Pathologie Tropicale et le Sida |
2020-09-15 | PHASE2 |
| NCT03174977 | UNKNOWN | HIV-1-infection |
University of California, San Francisco |
2018-04-01 | EARLY_PHASE1 |
| NCT04258475 | UNKNOWN | Calcium Supplementation in HIV Patients Using Raltegravir |
Ottawa Hospital Research Institute |
2020-12-09 | PHASE4 |
| NCT03954327 | COMPLETED | Primary Biliary Cholangitis |
University of Alberta |
2021-03-01 | PHASE2 |
| NCT02691065 | COMPLETED | HIV |
McGill University Health Centre/Research Institute of the McGill University Health Centre |
2017-01-20 | PHASE4 |
| NCT03311945 | COMPLETED | HIV Infections; HIV-1-infection; HIV Seropositivity |
Judit Pich |
2018-05-02 | PHASE3 |
| NCT04513626 | Recruiting | HIV Infections |
Centre de Recherches et d''Etude sur la Pathologie Tropicale et le Sida |
2020-09-15 | Phase 2 |
| NCT03333083 | TERMINATED | HIV Seropositivity; HIV Infections; HIV-1-infection |
Judit Pich |
2018-05-03 | PHASE3 |
| NCT03394196 | TERMINATED | HIV-2 Infection |
University of Washington |
2018-07-04 | |
| NCT03029689 | COMPLETED | HIV |
Fundación FLS de Lucha Contra el Sida, las Enfermedades Infecciosas y la Promoción de la Salud y la Ciencia |
2017-07-28 | PHASE3 |
| NCT03732625 | UNKNOWN | HIV Infections |
Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud |
2019-05 | PHASE4 |
| NCT01751568 | COMPLETED | HIV Infections; Tuberculosis |
National Institute of Allergy and Infectious Diseases (NIAID) |
2014-11-12 | PHASE1; PHASE2 |
| NCT03374358 | COMPLETED | HIV Seropositivity; Metabolic Syndrome; Fatty Liver |
Helsinki University Central Hospital |
2018-01-10 | PHASE4 |
| NCT03195452 | COMPLETED | Virus-HIV |
Nantes University Hospital |
2017-11-08 | PHASE2 |
| NCT02150993 | COMPLETED | HIV-2 Infection |
ANRS, Emerging Infectious Diseases |
2016-01-26 | PHASE2; PHASE3 |
| NCT02655471 | COMPLETED | HTLV-I Infections; Tropical Spastic Paraparesis |
Universidad Peruana Cayetano Heredia |
2017-07-01 | EARLY_PHASE1 |
| NCT02210715 | COMPLETED | HIV; Fatty Liver; Nonalcoholic Steatohepatitis |
McGill University Health Centre/Research Institute of the McGill University Health Centre |
2015-03 | PHASE4 |
| NCT01618305 | COMPLETED | HIV Infections |
Westat |
2013-09-05 | PHASE4 |
| NCT01896921 | COMPLETED | HIV |
University of Maryland, Baltimore |
2013-09 | PHASE3 |
| NCT02273765 | COMPLETED | HIV-1 Infection; Tuberculosis |
ANRS, Emerging Infectious Diseases |
2015-09-11 | PHASE3 |
| NCT03667547 | COMPLETED | Human Immunodeficiency Virus (HIV) Infection |
Merck Sharp & Dohme LLC |
2018-09-27 | PHASE4 |
| NCT01867320 | COMPLETED | HTLV-I Infection |
National Institute of Neurological Disorders and Stroke (NINDS) |
2013-09-05 | EARLY_PHASE1 |
| NCT03205566 | COMPLETED | Hiv |
Guy's and St Thomas' NHS Foundation Trust |
2017-09-19 | PHASE4 |
| NCT03667547 | Completed | Human Immunodeficiency Virus (HIV) Infection |
Merck Sharp & Dohme LLC |
2018-09-27 | Phase 4 |
| NCT02577042 | COMPLETED | Aging-related Inflammation in HIV-infected Patients |
Fundación FLS de Lucha Contra el Sida, las Enfermedades Infecciosas y la Promoción de la Salud y la Ciencia |
2015-10-15 | PHASE4 |
| NCT03174977 | Recruiting | HIV-1-infection |
University of California San Francisco|Merck Sharp & Dohme LLC |
2018-04-01 | Early Phase 1 |
| NCT01780831 | COMPLETED | HIV Infections |
National Institute of Allergy and Infectious Diseases (NIAID) |
2014-01-28 | PHASE1 |
| NCT01900106 | COMPLETED | HIV Infection |
University of Modena and Reggio Emilia |
2013-11 | PHASE3 |
| NCT02336074 | COMPLETED | HIV |
Imperial College London |
2015-11-27 | PHASE2 |
| NCT01829802 | UNKNOWN | Chronic Infection With HIV |
Pedro Cahn |
2014-05 | PHASE4 |
| NCT02212379 | COMPLETED | HIV-1 Infection |
ANRS, Emerging Infectious Diseases |
2015-01 | PHASE2 |
| NCT01854762 | TERMINATED | HIV; Pregnancy |
Fundação Bahiana de Infectologia |
2015-06-01 | PHASE2; PHASE3 |
| NCT02116660 | TERMINATED | HIV Infections |
Merck Sharp & Dohme LLC |
2014-09-03 | PHASE2 |
| NCT03537404 | COMPLETED | Healthy |
R-Pharm |
2017-04-24 | PHASE1 |
| NCT02284035 | COMPLETED | AIDS |
Juan A. Arnaiz |
2015-09-27 | PHASE3 |
| NCT01601626 | TERMINATED | HIV Infection; Tuberculosis |
Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections |
2013-07-13 | PHASE2 |
| NCT01900015 | COMPLETED | HCV Coinfection; HIV Infection |
Juan Macías |
2014-02-03 | PHASE4 |
| NCT02099474 | COMPLETED | HIV-1 Infection; PREGNANCY |
ANRS, Emerging Infectious Diseases |
2014-06-30 | PHASE2 |
| NCT01902186 | TERMINATED | HIV Infection; Osteopenia |
Giovanni Di Perri |
2014-09 | PHASE4 |
| NCT01641367 | COMPLETED | HIV-1 Infection |
Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections |
2013-02-22 | PHASE4 |
| NCT01978743 | COMPLETED | HIV; HIV-associated Neurocognitive Disorder; Neurotoxicity |
Massachusetts General Hospital |
2014-01 | |
| NCT02025868 | UNKNOWN | HIV Infection |
ANRS, Emerging Infectious Diseases |
2013-03 | PHASE2 |
| NCT02219672 | UNKNOWN | AIDS/HIV PROBLEM |
Peking Union Medical College |
2014-07 | PHASE3 |
| NCT01147107 | COMPLETED | Hepatitis C, Chronic; HIV Infection |
University of Hawaii |
2014-02 | PHASE4 |
| NCT02351908 | COMPLETED | HIV |
St Stephens Aids Trust |
2015-03 | PHASE4 |
| NCT02383355 | COMPLETED | HIV |
Radboud University Medical Center |
2015-03-01 | PHASE4 |
| NCT02611895 | COMPLETED | HIV-1 Infection |
University Hospital, Montpellier |
2015-03 | |
| NCT01231685 | COMPLETED | HIV; Hepatitis C; Liver Fibrosis |
McGill University Health Centre/Research Institute of the McGill University Health Centre |
2011-12 | PHASE2 |
| NCT01825031 | COMPLETED | Human Immunodeficiency Virus |
Anna Griffiths, MRC |
2013-06 | PHASE3 |
| NCT01784302 | COMPLETED | HIV |
Helen Reynolds |
2014-04 | PHASE1 |
| NCT02131233 | COMPLETED | HIV Infection |
Merck Sharp & Dohme LLC |
2014-05-23 | PHASE3 |
| NCT01605890 | COMPLETED | HIV-2 Infection |
ANRS, Emerging Infectious Diseases |
2012-07 | PHASE2 |
| NCT01844310 | UNKNOWN | AIDS/HIV PROBLEM |
Peking Union Medical College |
2013-05 | |
| NCT02097108 | COMPLETED | HIV Infections |
Arbeitsgemeinschaft medikamentoese Tumortherapie |
2014-05 | PHASE2 |
| NCT01291459 | UNKNOWN | HIV |
Association Pour la Recherche en Infectiologie |
2011-09 | PHASE2 |
| NCT01989910 | COMPLETED | HIV-1 Infection |
Taipei Veterans General Hospital, Taiwan |
2013-09 | PHASE4 |
| NCT01453192 | COMPLETED | HIV-1 Infection; Chronic Renal Insufficiency |
ANRS, Emerging Infectious Diseases |
2011-12 | PHASE3 |
| NCT02247687 | TERMINATED | HIV-1 Infection; Treatment Resistant Disorders; Viremia |
ANRS, Emerging Infectious Diseases |
2014-12 | PHASE3 |
| NCT02473367 | COMPLETED | HIV Infection |
Merck Sharp & Dohme LLC |
2015-06-23 | PHASE1 |
| NCT01275183 | COMPLETED | Head and Neck Cancer |
New Mexico Cancer Research Alliance |
2010-12 | EARLY_PHASE1 |
| NCT01285050 | COMPLETED | HIV Infection; Hepatitis C |
Johns Hopkins University |
2011-01 | PHASE4 |
| NCT01679964 | COMPLETED | HIV Infection; Adverse Drug Reaction; Quality of Life |
Lin, Hsi-Hsun, M.D. |
2012-07 | PHASE4 |
| NCT01352715 | COMPLETED | HIV-1 Infection |
Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections |
2012-03-13 | PHASE3 |
| NCT02489487 | COMPLETED | HIV-infection |
Viriom |
2014-09 | PHASE1 |
| NCT01453933 | UNKNOWN | HIV Infection; Endothelial Dysfunction |
UMC Utrecht |
2012-01 | PHASE4 |
| NCT01767701 | COMPLETED | Relapsing Remitting Multiple Sclerosis |
Queen Mary University of London |
2013-04 | PHASE2 |
| NCT01154673 | COMPLETED | Acute HIV Infection |
University of Toronto |
2011-11 | PHASE2; PHASE3 |
| NCT01576731 | COMPLETED | HIV Infection |
Hospital Clinic of Barcelona |
2012-07 | PHASE4 |
| NCT01450189 | COMPLETED | HIV |
University of North Carolina, Chapel Hill |
2011-10 | |
| NCT01258439 | COMPLETED | HIV; Cardiovascular Disease |
St Vincent's Hospital, Sydney |
2010-11 | PHASE4 |
| NCT01204905 | COMPLETED | HIV Infections |
University of Maryland, Baltimore |
2010-09 | |
| NCT01343225 | UNKNOWN | HIV |
East Carolina University |
2011-05 | PHASE4 |
| NCT01000285 | COMPLETED | Leukemia-Lymphoma, Adult T-Cell |
Washington University School of Medicine |
2010-09 | PHASE1; PHASE2 |
| NCT01480713 | COMPLETED | HIV-1 Infection |
IrsiCaixa |
2012-05 | PHASE3 |
| NCT01978782 | COMPLETED | HIV; Depression |
Radboud University Medical Center |
2014-01 | PHASE1 |
| NCT00988039 | COMPLETED | Human Immunodeficiency Virus; HIV |
Justine Boles |
2010-03 | PHASE3 |
| NCT01717287 | COMPLETED | HIV Infection |
Merck Sharp & Dohme LLC |
2012-11-16 | PHASE2 |
| NCT01930045 | COMPLETED | HIV Infections |
Merck Sharp & Dohme LLC |
2013-10-01 | PHASE1 |
| NCT01620736 | WITHDRAWN | Human T-cell Leukemia Virus Type 1 Infection |
Washington University School of Medicine |
2012-01 | PHASE2 |
| NCT01525628 | COMPLETED | Hepatitis C, Chronic |
Boehringer Ingelheim |
2012-04 | PHASE1 |
| NCT01214759 | COMPLETED | HIV |
The University of Texas Health Science Center, Houston |
2011-05 | PHASE4 |
| NCT00525733 | COMPLETED | HIV Infections |
Rockefeller University |
2007-10 | |
| NCT00843713 | COMPLETED | HIV Infection; Inflammation; Cardiovascular Disease; HIV Infections |
University of California, San Francisco |
2009-01 | PHASE4 |
| NCT01448486 | TERMINATED | Human Immunodeficiency Virus (HIV); HIV Associated Neurocognitive Disorders (HAND) |
St Vincent's Hospital, Sydney |
2011-10 | PHASE4 |
| NCT01066962 | COMPLETED | HIV Infections |
ANRS, Emerging Infectious Diseases |
2010-08 | PHASE3 |
| NCT01841593 | COMPLETED | HIV |
St Stephens Aids Trust |
2013-04 | PHASE1 |
| NCT01332227 | COMPLETED | HIV, Combination Therapy |
Bristol-Myers Squibb |
2011-10 | PHASE4 |
| NCT01330199 | COMPLETED | Healthy Adult Females |
University of North Carolina, Chapel Hill |
2012-02 | PHASE1 |
| NCT01565889 | COMPLETED | Hepatitis C; HIV |
Gilead Sciences |
2012-03 | PHASE1; PHASE2 |
| NCT00976404 | COMPLETED | HIV Infection |
Robert L. Murphy |
2009-11 | PHASE2 |
| NCT01033760 | COMPLETED | HIV-1 Infections |
ANRS, Emerging Infectious Diseases |
2010-04 | PHASE3 |
| NCT01779687 | COMPLETED | HIV; Hypercholesterolaemia |
Radboud University Medical Center |
2013-03 | PHASE1 |
| NCT00485264 | COMPLETED | HIV Infections |
National Institute of Allergy and Infectious Diseases (NIAID) |
2007-09-17 | PHASE1; PHASE2 |
| NCT00811954 | COMPLETED | HIV Infection |
Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections |
2009-05 | PHASE3 |
| NCT01424826 | COMPLETED | HIV; Tuberculosis |
Helen Reynolds |
2012-01 | PHASE1 |
| NCT00984152 | WITHDRAWN | HIV-1 Infections |
Rush University Medical Center |
2011-06 | PHASE3 |
| NCT01164605 | UNKNOWN | HIV Infection |
Southern California Institute for Research and Education |
2010-10 | |
| NCT01293123 | TERMINATED | HIV |
University of California, San Diego |
2011-12 | |
| NCT01195467 | COMPLETED | HIV Infection |
St Stephens Aids Trust |
2010-10 | PHASE3 |
| NCT01234116 | COMPLETED | Human Immunodeficiency Virus |
Henry Ford Health System |
2011-02 | PHASE4 |
| NCT00814879 | COMPLETED | Acquired Immune Deficiency Syndrome; AIDS; Human Immunodeficiency Virus; HIV Infections |
Yale University |
2009-05 | |
| NCT01022476 | COMPLETED | HIV Infection; Liver Failure; Evidence of Liver Transplantation |
ANRS, Emerging Infectious Diseases |
2010-05 | PHASE1; PHASE2 |
| NCT00870363 | COMPLETED | HIV Infections |
University of California, Davis |
2009-04 | PHASE4 |
| NCT01420523 | TERMINATED | Human Immunodeficiency Virus; Lipohypertrophy |
ANRS, Emerging Infectious Diseases |
2011-12 | PHASE2 |
| NCT01785160 | COMPLETED | Healthy |
Boehringer Ingelheim |
2013-02 | PHASE1 |
| NCT01059422 | COMPLETED | HIV Infections; Tuberculosis |
Central Institute of Epidemiology, Moscow, Russia |
2010-10 | PHASE4 |
| NCT01384734 | COMPLETED | Infection, Human Immunodeficiency Virus |
ViiV Healthcare |
2011-07-26 | PHASE2 |
| NCT01231516 | COMPLETED | Infection, Human Immunodeficiency Virus; HIV Infections |
ViiV Healthcare |
2010-10-26 | PHASE3 |
| NCT01105611 | UNKNOWN | HIV Infections; Hepatitis C |
St. James's Hospital, Ireland |
2010-08 | PHASE4 |
| NCT01335620 | COMPLETED | HIV |
Imperial College London |
2011-04 | PHASE4 |
| NCT00762892 | COMPLETED | HIV Infections |
The University of Texas Health Science Center, Houston |
2009-01 | PHASE4 |
| NCT01327482 | COMPLETED | HIV |
University of Washington |
2011-10 | |
| NCT01533259 | COMPLETED | Acquired Immunodeficiency Syndrome; HIV Infections |
Gilead Sciences |
2012-01 | PHASE3 |
| NCT01025427 | COMPLETED | HIV; HIV Infections |
University of California, San Francisco |
2009-12 | PHASE4 |
| NCT01173510 | WITHDRAWN | HIV Infections; Acquired Immune Deficiency Syndrome |
Community Research Initiative of New England |
2010-08-23 | PHASE4 |
| NCT01622673 | COMPLETED | HIV Infections |
Merck Sharp & Dohme LLC |
2012-06 | PHASE1 |
| NCT01245101 | TERMINATED | HIV |
University of Miami |
2010-11 | PHASE4 |
| NCT01270802 | COMPLETED | HIV |
Indiana University |
2011-04 | PHASE4 |
| NCT00677300 | COMPLETED | HIV Infections |
Dallas VA Medical Center |
2009-01 | PHASE4 |
| NCT01513122 | COMPLETED | HIV |
Kirby Institute |
2010-02 | PHASE4 |
| NCT00931463 | COMPLETED | HIV Infections |
Kirby Institute |
2009-09 | PHASE4 |
| NCT01114425 | COMPLETED | HIV Infections |
Groupe d'Etude sur le Risque d'Exposition des Soignants aux Agents Infectieux |
2010-11-01 | PHASE3 |
| NCT01225705 | WITHDRAWN | HIV; Hepatitis C |
University Hospital, Bonn |
2010-10 | PHASE4 |
| NCT00734344 | COMPLETED | Acute HIV Infection |
University of Alabama at Birmingham |
2008-09 | |
| NCT01318096 | UNKNOWN | HBV Coinfection; HIV Infections |
Yunnan AIDS Care Center |
2011-03 | |
| NCT00939874 | COMPLETED | HIV; Osteopenia; Osteoporosis; HIV Infections |
St Vincent's Hospital, Sydney |
2009-10 | PHASE4 |
| NCT00887653 | COMPLETED | HIV; Hyperlipidemia; Hypertriglyceridemia; HIV Infections |
The Miriam Hospital |
2009-05 | PHASE3 |
| NCT00537394 | COMPLETED | HIV Infections |
National Institute of Allergy and Infectious Diseases (NIAID) |
2008-01 | PHASE3 |
| NCT01087840 | COMPLETED | HIV Prevention; HIV Infections |
Andrew Carr |
2010-07 | PHASE4 |
| NCT01201239 | UNKNOWN | HIV |
Shanghai Public Health Clinical Center |
2010-09 | PHASE4 |
| NCT01531647 | COMPLETED | Healthy Volunteer |
Hoffmann-La Roche |
2012-01 | PHASE1 |
| NCT01529749 | COMPLETED | HIV-1 Infection |
Felipe Garcia |
2012-02 | PHASE4 |
| NCT01227824 | COMPLETED | Infection, Human Immunodeficiency Virus I |
ViiV Healthcare |
2010-10-19 | PHASE3 |
| NCT00931801 | COMPLETED | HIV |
Community Research Initiative of New England |
2009-12 | PHASE4 |
| NCT00808184 | COMPLETED | Solid Tumor |
National University Hospital, Singapore |
2010-04 | PHASE4 |
| NCT01294761 | COMPLETED | HIV Infections |
National Center for Global Health and Medicine, Japan |
2011-02 | |
| NCT00781287 | TERMINATED | Human Immunodeficiency Virus |
University of Washington |
2009-02 | PHASE4 |
| NCT00654147 | COMPLETED | HIV Infections |
Margaret A. Fischl, M.D. |
2008-04 | PHASE2 |
| NCT01042652 | UNKNOWN | HIV; HIV Infections |
Centers for Disease Control and Prevention, China |
2011-02 | |
| NCT00807443 | COMPLETED | HIV-1; HIV Infections |
Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal |
2009-09 | PHASE2 |
| NCT00667433 | COMPLETED | HIV Infections |
David A Wohl, MD |
2008-06 | PHASE1 |
| NCT00656175 | COMPLETED | HIV Infections; Lipodystrophy |
University of California, Los Angeles |
2008-09 | PHASE2 |
| NCT00822315 | COMPLETED | HIV Infections; Tuberculosis |
ANRS, Emerging Infectious Diseases |
2009-07 | PHASE2 |
| NCT01325051 | COMPLETED | Healthy Volunteer |
Angela Kashuba, PharmD |
2011-04 | PHASE1 |
| NCT01288417 | COMPLETED | HIV Infections; HCV Infections |
Radboud University Medical Center |
2011-08 | PHASE1 |
| NCT00808002 | COMPLETED | HIV Infections |
Germans Trias i Pujol Hospital |
2009-02 | PHASE3 |
| NCT00785967 | WITHDRAWN | HIV Infections |
McGill University Health Centre/Research Institute of the McGill University Health Centre |
2009-01 | PHASE3 |
| NCT00749580 | COMPLETED | Virus Diseases; HIV |
University of South Florida |
2008-11 | |
| NCT00874523 | COMPLETED | HIV Infection |
Kirby Institute |
2009-07 | PHASE3 |
| NCT01289951 | COMPLETED | Human Immunodeficiency Virus; Hepatitis C |
Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal |
2010-12 | PHASE1 |
| NCT00745368 | COMPLETED | HIV Infections |
University of Rochester |
2008-09 | |
| NCT00752856 | COMPLETED | HIV Infections |
University of California, San Diego |
2008-08-26 | PHASE2 |
| NCT00809718 | COMPLETED | Healthy |
The University of Texas Health Science Center at San Antonio |
2009-02 | PHASE1 |
| NCT00773708 | COMPLETED | HIV Infections |
Germans Trias i Pujol Hospital |
2009-03 | PHASE4 |
| NCT01214486 | COMPLETED | HIV |
University of Nebraska |
2010-10-01 | |
| NCT01241773 | COMPLETED | Hepatitis C Virus |
Tibotec Pharmaceuticals, Ireland |
2010-10 | PHASE1 |
| NCT00772720 | UNKNOWN | Healthy Volunteers |
Hospital Clinic of Barcelona |
2010-03 | PHASE1 |
| NCT01246804 | COMPLETED | HIV Infections; Depression; Mild Cognitive Impairment |
Radboud University Medical Center |
2010-11 | PHASE1 |
| NCT00641641 | COMPLETED | HIV Infection |
Kirby Institute |
2008-03 | |
| NCT00764946 | COMPLETED | Human Immunodeficiency Virus |
Merck Sharp & Dohme LLC |
2008-10 | PHASE3 |
| NCT00738569 | COMPLETED | HIV |
National Jewish Health |
2008-07 | |
| NCT00729924 | COMPLETED | HIV Infections |
Vanderbilt University |
2008-08 | PHASE2; PHASE3 |
| NCT01044771 | COMPLETED | HIV Infections; Proteinuria |
Metropolis Medical |
2010-01 | |
| NCT00943540 | COMPLETED | HIV Infection; HIV Infections |
Radboud University Medical Center |
2009-07 | PHASE2 |
| NCT00708162 | COMPLETED | HIV Infection |
Gilead Sciences |
2008-07 | PHASE3 |
| NCT00562510 | TERMINATED | HIV Infections |
Pedro Cahn |
2008-08 | PHASE3 |
| NCT01159132 | COMPLETED | HIV Infections |
The HIV Netherlands Australia Thailand Research Collaboration |
2010-04 | PHASE2 |
| NCT00958100 | COMPLETED | HIV/AIDS; Antiretroviral Therapy; HIV Infections |
Catholic University of the Sacred Heart |
2009-08 | PHASE2 |
| NCT00950859 | COMPLETED | Infection, Human Immunodeficiency Virus |
ViiV Healthcare |
2009-08 | PHASE2 |
| NCT00745823 | TERMINATED | HIV |
Merck Sharp & Dohme LLC |
2008-09 | PHASE3 |
| NCT00672932 | COMPLETED | HIV Infections |
University of California, San Francisco |
2008-04 | |
| NCT01121809 | COMPLETED | HIV-1 Infection; HIV Infections |
Hospitales Universitarios Virgen del Rocío |
2010-04 | PHASE4 |
| NCT00661960 | COMPLETED | HIV Infections; AIDS |
University of California, Davis |
2008-03 | |
| NCT01101893 | COMPLETED | Infection, Human Immunodeficiency Virus |
ViiV Healthcare |
2010-04 | PHASE1 |
| NCT00752037 | COMPLETED | HIV Infections |
Saint Michael's Medical Center |
2008-09 | PHASE4 |
| NCT00528892 | COMPLETED | HIV Infections |
Hospital Clinic of Barcelona |
2008-01 | PHASE3 |
| NCT00772590 | COMPLETED | HIV Infections |
Kirby Institute |
2009-03 | PHASE4 |
| NCT02182375 | COMPLETED | Healthy |
Boehringer Ingelheim |
2010-01 | PHASE1 |
| NCT00594646 | COMPLETED | HIV Infections |
Fenway Community Health |
2008-02 | PHASE4 |
| NCT00863668 | WITHDRAWN | HIV Infection; HIV Infections |
University of Minnesota |
2009-03 | |
| NCT01027182 | COMPLETED | Human Immunodeficiency Virus |
Changi General Hospital |
2009-12 | PHASE1 |
| NCT00782301 | WITHDRAWN | Hepatitis B; Human Immunodeficiency Virus; Hepatitis C, Chronic |
ViiV Healthcare |
2009-03 | PHASE4 |
| NCT00830804 | COMPLETED | HIV-1 Infections |
Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections |
2009-04 | PHASE2 |
| NCT00632970 | TERMINATED | HIV Infections |
George Washington University |
2008-02 | PHASE4 |
| NCT00787774 | UNKNOWN | HIV Infection |
Hospital Clinic of Barcelona |
2008-11 | |
| NCT00768989 | TERMINATED | HIV |
Bristol-Myers Squibb |
2008-11 | PHASE2 |
| NCT00944307 | COMPLETED | HIV Infections |
University of Colorado, Denver |
2009-07 | PHASE1 |
| NCT01047995 | COMPLETED | HIV Infections |
St Stephens Aids Trust |
2009-06 | PHASE1 |
| NCT00941083 | UNKNOWN | HIV Infections |
Hospital Carlos III, Madrid |
2009-01 | PHASE4 |
| NCT00858962 | COMPLETED | HIV Infection; HIV Infections |
Yale University |
2009-03 | |
| NCT00884793 | COMPLETED | HIV Infections |
University of California, San Francisco |
2008-09 | |
| NCT00944957 | UNKNOWN | Sleep Disorders; HIV Infections |
University Hospital, Geneva |
2009-11 | |
| NCT00995241 | COMPLETED | HIV Infections |
Germans Trias i Pujol Hospital |
2009-11 | PHASE4 |
| NCT00711009 | COMPLETED | Human Immunodeficiency Virus Infection |
Abbott |
2008-07 | PHASE3 |
| NCT00982553 | COMPLETED | HIV Infections |
Imperial College London |
2009-09 | PHASE1 |
| NCT00751153 | UNKNOWN | HIV Infections |
Peter J. Ruane, M.D., Inc. |
2008-03 | PHASE4 |
| NCT00631449 | COMPLETED | HIV Infections |
University of California, San Francisco |
2008-02 | PHASE4 |
| NCT00740064 | UNKNOWN | HIV Infections |
Denver Infectious Disease Consultants, PLLC |
2008-05 | PHASE4 |
| NCT00554398 | COMPLETED | HIV Infections |
Germans Trias i Pujol Hospital |
2007-11 | PHASE3 |
| NCT00443703 | TERMINATED | HIV Infection |
Merck Sharp & Dohme LLC |
2007-05 | PHASE3 |
| NCT00685191 | COMPLETED | HIV Infections |
Germans Trias i Pujol Hospital |
2008-06 | PHASE4 |
| NCT00802074 | COMPLETED | Healthy |
Garden State Infectious Disease Associates, PA |
2008-12 | |
| NCT00618371 | COMPLETED | HIV Infection |
University of Pittsburgh |
2007-10 | |
| NCT01000818 | COMPLETED | HIV-1 Infection; HIV Infections |
Merck Sharp & Dohme LLC |
2008-06 | PHASE1 |
| NCT00523237 | COMPLETED | HIV Infections |
Stanford University |
2007-10 | |
| NCT00520897 | COMPLETED | HIV Infections |
Canadian Immunodeficiency Research Collaborative |
2007-04 | PHASE2 |
| NCT00660972 | COMPLETED | HIV Infections |
National Institute of Allergy and Infectious Diseases (NIAID) |
2008-05 | PHASE1 |
| NCT00718536 | COMPLETED | HIV Infections |
Germans Trias i Pujol Hospital |
2008-08 | PHASE4 |
| NCT00746499 | COMPLETED | Pharmacokinetics |
University of North Carolina, Chapel Hill |
2008-09 | PHASE1 |
| NCT00784420 | COMPLETED | Healthy Volunteers |
Pfizer |
2008-09 | PHASE1 |
| NCT00618241 | COMPLETED | HIV Infection |
Radboud University Medical Center |
2008-02 | PHASE1 |
| NCT00488059 | TERMINATED | HIV Infections |
Hoffmann-La Roche |
2007-06 | PHASE4 |
| NCT00765271 | COMPLETED | HIV |
St Stephens Aids Trust |
2008-05 | PHASE1 |
| NCT00443729 | TERMINATED | HIV Infection |
Merck Sharp & Dohme LLC |
2007-05 | PHASE3 |
| NCT00614458 | TERMINATED | HIV Infections |
University of North Carolina, Chapel Hill |
2007-04 | PHASE2 |
| NCT00515827 | COMPLETED | HIV Infections |
National Institute of Allergy and Infectious Diseases (NIAID) |
2007-11 | PHASE2 |
| NCT00454337 | COMPLETED | HIV Infections |
French National Agency for Research on AIDS and Viral Hepatitis |
2007-05 | PHASE3 |
| NCT00665717 | COMPLETED | HIV Infections |
Radboud University Medical Center |
2008-05 | PHASE1 |
| NCT00531999 | COMPLETED | HIV Infections |
St Stephens Aids Trust |
2007-10 | PHASE1 |
| NCT00772551 | COMPLETED | HIV |
St Stephens Aids Trust |
2008-06 | PHASE1 |
| NCT00529243 | COMPLETED | HIV Infections |
Kaiser Permanente |
2007-09 | PHASE3 |
| NCT00614991 | COMPLETED | Healthy |
Garden State Infectious Disease Associates, PA |
2008-01 | |
| NCT00666705 | COMPLETED | Healthy |
ViiV Healthcare |
2008-02 | PHASE4 |
| NCT00460382 | COMPLETED | HIV Infections |
French National Agency for Research on AIDS and Viral Hepatitis |
2007-05 | PHASE2 |
| NCT00564772 | COMPLETED | Healthy |
Allina Health System |
2007-11 | PHASE4 |
| NCT00518297 | COMPLETED | HIV Infections |
Bristol-Myers Squibb |
2007-08 | PHASE1 |
| NCT00293254 | COMPLETED | HIV Infections |
Merck Sharp & Dohme LLC |
2006-02 | PHASE3 |
| NCT00293267 | COMPLETED | HIV Infections |
Merck Sharp & Dohme LLC |
2006-02 | PHASE3 |
| NCT01013987 | UNKNOWN | HIV-1 Adults Patients; AIDS; Triple Class Failure |
Fundación Huésped |
2010-02 | PHASE4 |
| NCT01253551 | COMPLETED | Hepatitis C |
Tibotec BVBA |
2010-12 | PHASE1 |
| NCT01288755 | COMPLETED | HIV Infections |
Tibotec Pharmaceuticals, Ireland |
2011-02 | PHASE1 |
(data from https://clinicaltrials.gov, updated on 2026-08-19)
Mechanism and Biochemical Profile
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>).