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

Management of Participants With Low-level Persistent Viremia (ANRS 161 L-VIR)

Phase 3
Terminated
Conditions
HIV-1 Infection
Treatment Resistant Disorders
Viremia
Interventions
First Posted Date
2014-09-25
Last Posted Date
2015-10-12
Lead Sponsor
ANRS, Emerging Infectious Diseases
Target Recruit Count
4
Registration Number
NCT02247687
Locations
🇫🇷

Hôpital Européen Georges Pompidou, France, France

🇫🇷

Hôpital Avicenne, Bobigny, France

🇫🇷

Hôpital Jean Verdier, Bondy, France

and more 17 locations

Comparison of Virologic and Immunologic Responses to Raltegravir and Dolutegravir in the Gastrointestinal Tract of HIV-Positive Adults

Completed
Conditions
Human Immunodeficiency Virus
Interventions
Procedure: Colonoscopy with biopsy
First Posted Date
2014-08-18
Last Posted Date
2018-12-26
Lead Sponsor
University of North Carolina, Chapel Hill
Target Recruit Count
20
Registration Number
NCT02218320
Locations
🇺🇸

Clinical and Translational Research Center, UNC Hospitals, Chapel Hill, North Carolina, United States

Capacity of the Dual Combination Raltegravir/Etravirine to Maintain Virological Success in HIV-1 Infected Patients of at Least 45 Years of Age- ANRS 163 ETRAL

Phase 2
Completed
Conditions
HIV-1 Infection
Interventions
First Posted Date
2014-08-08
Last Posted Date
2021-04-27
Lead Sponsor
ANRS, Emerging Infectious Diseases
Target Recruit Count
170
Registration Number
NCT02212379
Locations
🇫🇷

Hôpital Cochin, Paris, France

🇫🇷

Hôpital Necker, Paris, France

🇫🇷

Hôpital Croix Rousse, Lyon, France

and more 16 locations

Effect of BI 201335 Mediated UGT1A1 (Uridine-diphosphate-glucuronosyltransferases) Inhibition in Healthy Volunteers

Phase 1
Completed
Conditions
Healthy
Interventions
First Posted Date
2014-07-08
Last Posted Date
2014-07-18
Lead Sponsor
Boehringer Ingelheim
Target Recruit Count
24
Registration Number
NCT02182375

Very Early Intensive Treatment of Infants Living With HIV to Achieve HIV Remission

Phase 1
Recruiting
Conditions
HIV Infection
Interventions
Drug: Nucleoside Reverse Transcriptase Inhibitors (NRTIs)
Drug: Lopinavir/Ritonavir (LPV/r)
First Posted Date
2014-05-16
Last Posted Date
2025-04-04
Lead Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
Target Recruit Count
1120
Registration Number
NCT02140255
Locations
🇺🇸

4601, University of California, San Diego Clinical Research Site, La Jolla, California, United States

🇺🇸

5048, University of Southern California Clinical Research Site, Los Angeles, California, United States

🇺🇸

5112, David Geffen School of Medicine at UCLA Clinical Research Site, Los Angeles, California, United States

and more 47 locations

Evaluation of the Safety and Efficacy of Reformulated Raltegravir (MK-0518) 1200 mg Once Daily in Combination With TRUVADA™ in Human Immunodeficiency Virus (HIV)-1 Infected, Treatment-Naive Participants (MK-0518-292)

Phase 3
Completed
Conditions
HIV Infection
Interventions
Drug: TRUVADA™
Drug: Placebo to Reformulated Raltegravir
First Posted Date
2014-05-06
Last Posted Date
2019-01-30
Lead Sponsor
Merck Sharp & Dohme LLC
Target Recruit Count
802
Registration Number
NCT02131233

Changes in Lipids and Lipoproteins in HIV Infected Women After Switch From Protease Inhibitor to Raltegravir

Phase 2
Completed
Conditions
HIV Infections
Interventions
First Posted Date
2014-03-26
Last Posted Date
2016-09-13
Lead Sponsor
Arbeitsgemeinschaft medikamentoese Tumortherapie
Target Recruit Count
11
Registration Number
NCT02097108
Locations
🇦🇹

AKH Wien, Wien, Austria

🇦🇹

PMU Salzburg, Salzburg, Austria

🇦🇹

Ottto Wagner Spital, Wien, Austria

Third Line Antiretroviral Treatment Optimization in Sub-Saharan Africa

Phase 2
Conditions
HIV Infection
Interventions
First Posted Date
2014-01-01
Last Posted Date
2017-02-17
Lead Sponsor
ANRS, Emerging Infectious Diseases
Target Recruit Count
201
Registration Number
NCT02025868
Locations
🇧🇫

CHU Yalgado Ouedraogo, Ouagadougou, Burkina Faso

🇧🇫

CHU Sourô Sanou, Bobo-Dioulasso, Burkina Faso

🇨🇮

Centre de Prise en Charge et de Formation (CePReF), Association ACONDA, Abidjan, Côte D'Ivoire

and more 4 locations

Compare the Efficacy and Safety of Raltegravir Versus Efavirenz Combination Therapy in Treatment-naïve HIV-1 Patients

Phase 4
Completed
Conditions
HIV-1 Infection
Interventions
First Posted Date
2013-11-21
Last Posted Date
2019-02-25
Lead Sponsor
Taipei Veterans General Hospital, Taiwan
Target Recruit Count
107
Registration Number
NCT01989910
Locations
🇨🇳

Division of Infectious Diseases, Taipei Veterans General Hospital, Taipei, Taiwan

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