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

Evaluating the Safety and Pharmacokinetics of Raltegravir in Infants

Completed
Conditions
HIV Infections
Interventions
First Posted Date
2013-04-10
Last Posted Date
2021-11-08
Lead Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
Target Recruit Count
40
Registration Number
NCT01828073
Locations
🇹🇭

Chiangrai Prachanukroh Hospital NICHD CRS, Chiang Mai, Thailand

🇺🇸

St. Jude Children's Research Hospital CRS, Memphis, Tennessee, United States

🇺🇸

University of California, UC San Diego CRS- Mother-Child-Adolescent HIV Program, La Jolla, California, United States

and more 16 locations

Reduction of EArly mortaLITY in HIV-infected Adults and Children Starting Antiretroviral Therapy

Phase 3
Completed
Conditions
Human Immunodeficiency Virus
Interventions
First Posted Date
2013-04-05
Last Posted Date
2016-04-20
Lead Sponsor
Anna Griffiths, MRC
Target Recruit Count
1805
Registration Number
NCT01825031
Locations
🇺🇬

Joint Clinical Research Centre, Mbale, Mbale, Uganda

🇰🇪

Moi University Clinical Research Centre, Eldoret, Kenya

🇰🇪

KEMRI Wellcome Trust Research Programme, Kilifi, Kenya

and more 5 locations

Investigation of Faldaprevir Effect on Pharmacokinetics of Raltegravir

Phase 1
Completed
Conditions
Healthy
Interventions
First Posted Date
2013-02-07
Last Posted Date
2015-08-03
Lead Sponsor
Boehringer Ingelheim
Target Recruit Count
25
Registration Number
NCT01785160
Locations
🇩🇪

1220.65.1 Boehringer Ingelheim Investigational Site, Mannheim, Germany

The Effect of Antacids and Multivitamins on Raltegravir

Phase 1
Completed
Conditions
HIV
Interventions
Drug: Maalox Plus extra
Dietary Supplement: Multivitamins
Dietary Supplement: Sodium bicarbonate
First Posted Date
2013-02-05
Last Posted Date
2016-02-25
Lead Sponsor
Helen Reynolds
Target Recruit Count
15
Registration Number
NCT01784302
Locations
🇬🇧

Royal Liverpool University Hospital, Liverpool, United Kingdom

Safety and Pharmacokinetics of Raltegravir in HIV-1-Exposed Newborn Infants at Risk of Acquiring HIV-1 Infection

Phase 1
Completed
Conditions
HIV Infections
Interventions
First Posted Date
2013-01-31
Last Posted Date
2021-11-05
Lead Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
Target Recruit Count
52
Registration Number
NCT01780831
Locations
🇿🇦

Umlazi CRS, Durban, KwaZulu-Natal, South Africa

🇹🇭

Siriraj Hospital ,Mahidol University NICHD CRS, Bangkok, Bangkoknoi, Thailand

🇺🇸

Univ. of Florida Jacksonville NICHD CRS, Jacksonville, Florida, United States

and more 12 locations

Pharmacokinetic Drug Interaction Study Between Raltegravir and Atorvastatin.

Phase 1
Completed
Conditions
Hypercholesterolaemia
HIV
Interventions
First Posted Date
2013-01-30
Last Posted Date
2020-10-20
Lead Sponsor
Radboud University Medical Center
Target Recruit Count
24
Registration Number
NCT01779687
Locations
🇳🇱

CRCN Radboud University Nijmegen Medical Centre, Nijmegen, Netherlands

Raltegravir (Isentress) Pilot Study in Relapsing Multiple Sclerosis

Phase 2
Completed
Conditions
Relapsing Remitting Multiple Sclerosis
Interventions
First Posted Date
2013-01-14
Last Posted Date
2017-05-30
Lead Sponsor
Queen Mary University of London
Target Recruit Count
23
Registration Number
NCT01767701
Locations
🇬🇧

The Royal London Hospital, London, United Kingdom

Safety, Tolerance and Pharmacokinetics of Raltegravir-Containing Antiretroviral Therapy in Infants, Children Infected With HIV and TB

Phase 1
Completed
Conditions
Tuberculosis
HIV Infections
Interventions
First Posted Date
2012-12-18
Last Posted Date
2021-11-05
Lead Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
Target Recruit Count
40
Registration Number
NCT01751568
Locations
🇿🇦

Soweto IMPAACT CRS, Johannesburg, Gauteng, South Africa

🇿🇦

Desmond Tutu TB Centre - Stellenbosch University (DTTC-SU) CRS, Cape Town, Western Cape Province, South Africa

🇿🇦

Wits RHI Shandukani Research Centre CRS, Johannesburg, Gauteng, South Africa

and more 1 locations

Sustained Virological Suppression and Improvement of Adverse Events of Switching to Raltegravir Study

Phase 4
Completed
Conditions
Quality of Life
HIV Infection
Adverse Drug Reaction
Interventions
First Posted Date
2012-09-06
Last Posted Date
2016-09-15
Lead Sponsor
Lin, Hsi-Hsun, M.D.
Target Recruit Count
107
Registration Number
NCT01679964
Locations
🇨🇳

Taipei City Hospital, Taipei, Taiwan

🇨🇳

National Taiwan University Hospital, Taipei, Taiwan

🇨🇳

China Medical University Hospital, Taichung, Taiwan

and more 4 locations
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