Raltegravir

Generic Name: Raltegravir

Brand Names: Isentress

Drug Type: Small Molecule

Chemical Formula: C_₂₀H_₂₁FN_₆O_₅

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

Clinical Trials

Raltegravir and Atazanavir Replacing Current Suppressive Treatment Because of Side Effects in Current Treatment

Phase 4

Conditions: HIV Infections

First Posted Date: 2008-09-11

Last Posted Date: 2008-10-09

Lead Sponsor: Peter J. Ruane, M.D., Inc.

Target Recruit Count: 40

Registration Number: NCT00751153

Locations: 🇺🇸
Medical Practice of Peter Ruane MB, Los Angeles, California, United States

Pharmacokinetic Study of Raltegravir in Healthy Premenopausal Women.

Phase 1

Completed

Conditions: Pharmacokinetics

Interventions: Drug: Raltegravir

First Posted Date: 2008-09-04

Last Posted Date: 2012-10-15

Lead Sponsor: University of North Carolina, Chapel Hill

Target Recruit Count: 7

Registration Number: NCT00746499

Locations: 🇺🇸
University of North Carolina, Chapel Hill, North Carolina, United States

Comparing Raltegravir Genital Tract Distribution in HIV-infected Men and Women

Not Applicable

Completed

Conditions: HIV Infections

Interventions: Drug: Raltegravir

First Posted Date: 2008-09-03

Last Posted Date: 2012-10-10

Lead Sponsor: University of Rochester

Target Recruit Count: 28

Registration Number: NCT00745368

Locations: 🇺🇸
University of Rochester, Rochester, New York, United States

Pilot Study With Isentress (Raltegravir) and Epzicom (Abacavir/Lamivudine) in Treatment Naive HIV-Infected Subjects

Phase 4

Conditions: HIV Infections

First Posted Date: 2008-08-22

Last Posted Date: 2009-01-28

Lead Sponsor: Denver Infectious Disease Consultants, PLLC

Target Recruit Count: 30

Registration Number: NCT00740064

Locations: 🇺🇸
Denver Infectious Disease Consultants, PLLC, Denver, Colorado, United States
🇺🇸
Spectrum Medical Group, Phoenix, Arizona, United States
🇺🇸
Southwest CARE Center, Santa Fe, New Mexico, United States

Assess the Downregulation of HIV-1 When Raltegravir is Added to a Virologically Suppressed HAART Regimen

Not Applicable

Completed

Conditions: HIV

Interventions: Drug: Raltegravir

First Posted Date: 2008-08-20

Last Posted Date: 2021-01-19

Lead Sponsor: National Jewish Health

Target Recruit Count: 30

Registration Number: NCT00738569

Locations: 🇺🇸
National Jewish Health, Denver, Colorado, United States

Pilot Study of Raltegravir/Truvada Versus Efavirenz/Truvada for Adults With Acute IV-1 Infection

Not Applicable

Completed

Conditions: Acute HIV Infection

Interventions: Drug: Raltegravir
Drug: Efavirenz
Drug: Emtricitibine
Drug: Tenofovir disoproxil once daily
Drug: Tenofovir disoproxil twice daily

First Posted Date: 2008-08-14

Last Posted Date: 2016-05-30

Lead Sponsor: University of Alabama at Birmingham

Target Recruit Count: 18

Registration Number: NCT00734344

Locations: 🇺🇸
UAB 1917 Clinic, Birmingham, Alabama, United States

Genetic Predictors of Raltegravir Penetration Into Cerebrospinal Fluid

Phase 2

Completed

Conditions: HIV Infections

Interventions: Drug: Raltegravir

First Posted Date: 2008-08-08

Last Posted Date: 2015-03-03

Lead Sponsor: Vanderbilt University

Target Recruit Count: 40

Registration Number: NCT00729924

Locations: 🇺🇸
Vanderbilt Therapeutics Clinical Research Site, Nashville, Tennessee, United States

Study Comparing Lopinavir/Ritonavir (LPV/r) + Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF) With a Nucleoside Sparing Regimen Consisting of Lopinavir/Ritonavir + Raltegravir (RAL)

Phase 3

Completed

Conditions: Human Immunodeficiency Virus Infection

Interventions: Drug: lopinavir/ritonavir (LPV/r)
Drug: raltegravir (RAL)
Drug: emtricitabine/tenofovir disoproxil fumarate (FTC/TDF)

First Posted Date: 2008-07-08

Last Posted Date: 2012-02-14

Lead Sponsor: Abbott

Target Recruit Count: 206

Registration Number: NCT00711009

Locations: 🇺🇸
Site Reference ID/Investigator# 8433, Houston, Texas, United States
🇺🇸
Site Reference ID/Investigator# 8395, Atlanta, Georgia, United States
🇨🇦
Site Reference ID/Investigator# 7831, Toronto, Ontario, Canada

and more 34 locations

Multicenter, Randomized, Double-Blind, Double-Dummy, Phase 3 Study of the Safety and Efficacy of Elvitegravir Versus Raltegravir

Phase 3

Completed

Conditions: HIV Infection

Interventions: Drug: Raltegravir
Drug: Elvitegravir
Drug: EVG placebo
Drug: RAL placebo
Drug: Background regimen

First Posted Date: 2008-07-02

Last Posted Date: 2016-05-30

Lead Sponsor: Gilead Sciences

Target Recruit Count: 724

Registration Number: NCT00708162

Locations: 🇺🇸
Whitman-Walker Clinic, Washington, District of Columbia, United States
🇺🇸
Orlando Immunology Center, Orlando, Florida, United States
🇺🇸
Wake Forest University Health Sciences, Winston-Salem, North Carolina, United States

and more 176 locations

Raltegravir And Darunavir Antiretroviral in Antiretroviral Naive Patients

Phase 4

Completed

Conditions: HIV Infections

Interventions: Drug: Raltegravir
Drug: Darunavir
Drug: Tenofovir/Emtricitabine
Drug: Ritonavir

First Posted Date: 2008-05-14

Last Posted Date: 2014-09-08

Lead Sponsor: Dallas VA Medical Center

Target Recruit Count: 85

Registration Number: NCT00677300

Locations: 🇺🇸
Dallas VA Medical Center, Dallas, Texas, United States
🇺🇸
Parkland Health & Hospital System, Dallas, Texas, United States

Drug Development Updates

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