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

A5288/MULTI-OCTAVE: Management Using Latest Technologies to Optimize Combination Therapy After Viral Failure

Phase 4
Completed
Conditions
HIV-1 Infection
Interventions
Drug: Second line ART regimens - based on a boosted protease inhibitor (bPI) plus two nucleoside analogues (NRTIs)
Drug: Study provided drugs according to patient resistance profile (DRV, ETR, RTV, FTC/TDF) + any in country available drug as applicable & available
Other: SOC adherence versus SOC+CPI adherence
First Posted Date
2012-07-16
Last Posted Date
2019-03-15
Lead Sponsor
Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections
Target Recruit Count
545
Registration Number
NCT01641367
Locations
🇧🇷

Hospital Nossa Senhora da Conceicao CRS (12201), Porto Alegre, RS, Brazil

🇧🇷

Instituto de Pesquisa Clinica Evandro Chagas (12101), Rio de Janeiro, Brazil

🇮🇳

Chennai Antiviral Research and Treatment (CART) CRS (11701), Chennai, Taramani, India

and more 16 locations

A Pharmacokinetic Study to Evaluate the Effect of Antacids on Raltegravir (MK-0518) in HIV-Infected Participants (MK-0518-247)

Phase 1
Completed
Conditions
HIV Infections
Interventions
Drug: MINTOX® Maximum Strength
First Posted Date
2012-06-19
Last Posted Date
2017-03-21
Lead Sponsor
Merck Sharp & Dohme LLC
Target Recruit Count
27
Registration Number
NCT01622673

Trial to Assess Effect of Raltegravir on HTLV-1 Proviral Load

Phase 2
Withdrawn
Conditions
Human T-cell Leukemia Virus Type 1 Infection
Interventions
First Posted Date
2012-06-15
Last Posted Date
2018-01-24
Lead Sponsor
Washington University School of Medicine
Registration Number
NCT01620736

Evaluating the Response to Two Antiretroviral Medication Regimens in HIV-Infected Pregnant Women, Who Begin Antiretroviral Therapy Between 20 and 36 Weeks of Pregnancy, for the Prevention of Mother-to-Child Transmission

Phase 4
Completed
Conditions
HIV Infections
Interventions
First Posted Date
2012-06-13
Last Posted Date
2020-01-30
Lead Sponsor
Westat
Target Recruit Count
408
Registration Number
NCT01618305
Locations
🇹🇭

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

🇹🇭

Bhumibol Adulyadej Hospital, Bangkok, Thailand

🇧🇷

Hospital Nossa Senhora da Conceicao NICHD CRS, Porto Alegre, Rio Grande Do Sul, Brazil

and more 16 locations

Rifampin-Based Tuberculosis Treatment Versus Rifabutin-Based Tuberculosis Treatment in Persons With HIV

Phase 2
Terminated
Conditions
HIV Infection
Tuberculosis
Interventions
Drug: Standard-dose Lopinavir/Ritonavir
Drug: Double-dose Lopinavir/Ritonavir
First Posted Date
2012-05-18
Last Posted Date
2018-02-13
Lead Sponsor
Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections
Target Recruit Count
71
Registration Number
NCT01601626
Locations
🇵🇪

Asociacion Civil Impacta Salud y Educacion - Miraf CRS (11301), Lima, Peru

🇧🇷

Instituto de Pesquisa Clinica Evandro Chagas (12101), Rio de Janeiro, Brazil

🇭🇹

Les Centres GHESKIO CRS (30022), Port-au-Prince, Haiti

and more 6 locations

Study Comparing Two Alternatives of Antiretroviral Therapy as Post-exposure Prophylaxis to HIV-1: Tenofovir + Emtricitabine + Lopinavir/Ritonavir Versus Tenofovir + Emtricitabine + Raltegravir (RAL-PEP)

Phase 4
Completed
Conditions
HIV Infection
Interventions
Drug: Tenofovir, Emtricitabine, Lopinavir/r
First Posted Date
2012-04-12
Last Posted Date
2015-04-01
Lead Sponsor
Hospital Clinic of Barcelona
Target Recruit Count
240
Registration Number
NCT01576731
Locations
🇪🇸

Hospital Clínic of Barcelona, Barcelona, Spain

A Study of Drug-Drug Interaction Between Danoprevir/Low-Dose Ritonavir and Raltegravir in Healthy Volunteers

Phase 1
Completed
Conditions
Healthy Volunteer
Interventions
First Posted Date
2012-02-13
Last Posted Date
2016-11-02
Lead Sponsor
Hoffmann-La Roche
Target Recruit Count
20
Registration Number
NCT01531647

Bone and Body Comp: A Sub Study of the SECOND-LINE Study

Phase 4
Completed
Conditions
HIV
Interventions
First Posted Date
2012-01-20
Last Posted Date
2019-09-04
Lead Sponsor
Kirby Institute
Target Recruit Count
210
Registration Number
NCT01513122
Locations
🇿🇦

Desmond Tutu HIV Foundation, Cape Town, South Africa

🇦🇷

CEADI, Buenos Aires, Argentina

🇹🇭

HIV-NAT Program on AIDS - Thai Red Cross, Bangkok, Thailand

and more 4 locations

Impact of Raltegravir Intensification on HIV-1-infected Subjects With Complete Viral Suppression Under Monotherapy With Protease Inhibitors

First Posted Date
2011-11-29
Last Posted Date
2024-05-07
Lead Sponsor
IrsiCaixa
Target Recruit Count
41
Registration Number
NCT01480713
Locations
🇪🇸

Germans Trias i Pujol Hospital, Badalona, Barcelona, Spain

RAltegravir Switch STudy: Effects on Endothelial Recovery

Phase 4
Conditions
HIV Infection
Endothelial Dysfunction
Interventions
First Posted Date
2011-10-18
Last Posted Date
2013-12-18
Lead Sponsor
UMC Utrecht
Target Recruit Count
24
Registration Number
NCT01453933
Locations
🇳🇱

Onze Lieve Vrouwe Gasthuis, Amsterdam, Noord Holland, Netherlands

🇳🇱

University Medical Center Utrecht, Utrecht, Netherlands

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