MedPath

Raltegravir

Generic Name
Raltegravir
Brand Names
Isentress
Drug Type
Small Molecule
Chemical Formula
C20H21FN6O5
CAS Number
518048-05-0
Unique Ingredient Identifier
22VKV8053U
Background

Raltegravir is an antiretroviral drug produced by Merck & Co., used to treat HIV infection. It received approval by the U.S. Food and Drug Administration (FDA) on 12 October 2007, the first of a new class of HIV drugs, the integrase inhibitors, to receive such approval.

Indication

For the treatment of HIV-1 infection in conjunction with other antiretrovirals.

Associated Conditions
Human Immunodeficiency Virus Type 1 (HIV-1) Infection
Associated Therapies
Post-exposure prophylaxis for occupational exposure to HIV therapy

Pregnancy and Neonatal Outcomes Following Antenatal Exposure to Raltegravir: a Pooled Analysis From the European Pregnancy and Paediatric Infections Cohort Collaboration (EPPICC)

Recruiting
Conditions
HIV Infections
Interventions
First Posted Date
2023-03-02
Last Posted Date
2023-03-02
Lead Sponsor
Fondazione Penta UK
Target Recruit Count
1200
Registration Number
NCT05751031
Locations
🇨🇭

University Hospital Zurich, Zürich, Switzerland

🇮🇹

Università degli studi di Firenze, Firenze, Italy

🇬🇧

University College London, London, United Kingdom

and more 7 locations

Study on PhArmacokinetics of First liNe Antiretrovirals in Healthy Breastfeeding Volunteers

First Posted Date
2022-12-13
Last Posted Date
2023-04-10
Lead Sponsor
Radboud University Medical Center
Target Recruit Count
36
Registration Number
NCT05648201
Locations
🇳🇱

Radboudumc, Nijmegen, Netherlands

The Influence of Concurrent Oral Calcium Carbonate Supplementation on Steady State Pharmacokinetics of Oral Raltegravir.

Phase 4
Recruiting
Conditions
Calcium Supplementation in HIV Patients Using Raltegravir
Interventions
First Posted Date
2020-02-06
Last Posted Date
2023-12-12
Lead Sponsor
Ottawa Hospital Research Institute
Target Recruit Count
12
Registration Number
NCT04258475
Locations
🇨🇦

The Ottawa Hospital General Campus, Ottawa, Ontario, Canada

Combination Antiretroviral Therapy (cART) for PBC

Phase 2
Completed
Conditions
Primary Biliary Cholangitis
Interventions
First Posted Date
2019-05-17
Last Posted Date
2024-02-16
Lead Sponsor
University of Alberta
Target Recruit Count
37
Registration Number
NCT03954327
Locations
🇨🇦

University of Alberta, Edmonton, Alberta, Canada

🇨🇦

University of Toronto, Toronto, Ontario, Canada

🇨🇦

University of Montreal, Montréal, Quebec, Canada

and more 3 locations

Neuropsyquiatric Evolution After Introduction of Raltegravir QD in Substitution of Dolutegravir: NEAR QD Study

Phase 4
Conditions
HIV Infections
Interventions
First Posted Date
2018-11-06
Last Posted Date
2019-02-15
Lead Sponsor
Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud
Target Recruit Count
50
Registration Number
NCT03732625
Locations
🇪🇸

Costa del Sol University Hospital, Marbella, Málaga, Spain

🇪🇸

Clínic University Hospital, Barcelona, Spain

🇪🇸

San Carlos Clinical Hospital, Madrid, Spain

Safety, Tolerability, and Pharmacokinetics of Raltegravir (MK-0518) in Healthy Japanese Male Participants (MK-0518-851)

Phase 4
Completed
Conditions
Human Immunodeficiency Virus (HIV) Infection
Interventions
First Posted Date
2018-09-12
Last Posted Date
2019-10-02
Lead Sponsor
Merck Sharp & Dohme LLC
Target Recruit Count
12
Registration Number
NCT03667547
Locations
🇯🇵

Medical Corporation Houeikai Sekino Clinical Pharmacology Clinic ( Site 0001), Tokyo, Japan

A Drug Interaction Study to Assess the Pharmacokinetics of Narlaprevir and Antiretroviral Drugs

First Posted Date
2018-05-25
Last Posted Date
2019-02-19
Lead Sponsor
R-Pharm
Target Recruit Count
36
Registration Number
NCT03537404
Locations
🇷🇺

Clinic "Bessalar" JSC, Moscow, Russian Federation

Effect on Liver Fat and Metabolic Parameters When Switching a Protease Inhibitor or Efavirenz to Raltegravir

Phase 4
Completed
Conditions
Fatty Liver
Metabolic Syndrome
HIV Seropositivity
Interventions
First Posted Date
2017-12-15
Last Posted Date
2021-09-05
Lead Sponsor
Helsinki University Central Hospital
Target Recruit Count
45
Registration Number
NCT03374358
Locations
🇫🇮

Aurora hospital, Department of Infectious Diseases, Helsinki, Finland

Study With Dual Therapy Including Lamivudine (300 mg QD) Plus Raltegravir (1200 mg QD) in Virologically Suppressed HIV-1 Infected Patients Experiencing Inconvenience, Toxicity, Negative Impact on Co-morbidities or Risk of Drug-drug Interactions With Their Current Regimen

Phase 3
Terminated
Conditions
HIV Seropositivity
HIV Infections
HIV-1-infection
Interventions
First Posted Date
2017-11-06
Last Posted Date
2025-05-18
Lead Sponsor
Judit Pich
Target Recruit Count
17
Registration Number
NCT03333083
Locations
🇪🇸

Hospital Clínic i Provincial de Barcelona, Barcelona, Spain

Simplification Study of HIV-1 Infected Patients With Virological Suppression Under the Combination of Lamivudine (150 mg BID) Plus Raltegravir (400 mg BID) Switching to Lamivudine (300 mg QD) Plus Raltegravir (1200 mg QD) : Roll-over Study of the RALAM

Phase 3
Conditions
HIV Infections
HIV-1-infection
HIV Seropositivity
Interventions
First Posted Date
2017-10-17
Last Posted Date
2018-07-31
Lead Sponsor
David Garcia Cinca
Target Recruit Count
49
Registration Number
NCT03311945
Locations
🇪🇸

Hospital Clínic i Provincial de Barcelona, Barcelona, Spain

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