Clinical Trials

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)

Check the Raltegravir product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

Raltegravir selectively binds to HIV integrase to inhibit catalytic strand transfer activity, thereby preventing the insertion of viral DNA into the host genome. This blockade of integration halts viral replication, providing the mechanism for maintaining virological suppression in clinical trial patients with HIV infections.

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>).

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