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

Pharmacokinetic Study on Raltegravir and Lamotrigine

Phase 1

Completed

Conditions: HIV Infection

Interventions: Drug: lamotrigine
Drug: Raltegravir

First Posted Date: 2008-02-19

Last Posted Date: 2020-10-19

Lead Sponsor: Radboud University Medical Center

Target Recruit Count: 24

Registration Number: NCT00618241

Locations: 🇳🇱
Radboud University Medical Center, Nijmegen, Gelderland, Netherlands

An Interaction Study to Assess Drug Levels in Healthy Adult Subjects

Not Applicable

Completed

Conditions: Healthy

Interventions: Drug: Raltegravir
Drug: Fosamprenavir
Drug: Ritonavir

First Posted Date: 2008-02-14

Last Posted Date: 2016-01-29

Lead Sponsor: Garden State Infectious Disease Associates, PA

Target Recruit Count: 44

Registration Number: NCT00614991

Raltegravir Added to Stable HAART in HIV-1 Infected Subjects With Viral Suppression and Low CD4 Recovery

Phase 3

Terminated

Conditions: HIV Infections

Interventions: Drug: Placebo
Drug: Raltegravir

First Posted Date: 2007-11-22

Last Posted Date: 2015-06-09

Lead Sponsor: Pedro Cahn

Target Recruit Count: 20

Registration Number: NCT00562510

Locations: 🇦🇷
Fundacion Huesped, Buenos Aires, Argentina

Characterization of Acute and Recent HIV-1 Infections in Zurich.

Not Applicable

Recruiting

Conditions: HIV Infections

Interventions: Drug: Dolutegravir
Drug: Elvitegravir, Cobicistat, Emtricitabine, and Tenofovir Alafenamid Fumarate
Drug: Raltegravir
Drug: Darunavir
Drug: Ritonavir
Drug: Rilpivirine
Drug: Lamivudine
Drug: tenofovir
Drug: Emtricitabine
Drug: Abacavir

First Posted Date: 2007-10-02

Last Posted Date: 2024-12-17

Lead Sponsor: University of Zurich

Target Recruit Count: 800

Registration Number: NCT00537966

Locations: 🇨🇭
University of Zurich, Zurich, Switzerland

Optimizing Treatment for Treatment-Experienced, HIV-Infected People

Phase 3

Completed

Conditions: HIV Infections

Interventions: Drug: Enfuvirtide
Drug: Raltegravir
Drug: Darunavir
Drug: Tipranavir
Drug: Etravirine
Drug: Maraviroc

First Posted Date: 2007-10-01

Last Posted Date: 2021-11-04

Lead Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)

Target Recruit Count: 517

Registration Number: NCT00537394

Locations: 🇺🇸
Children's National Med. Ctr. ATN CRS, Washington, District of Columbia, United States
🇺🇸
Univ. of Rochester ACTG CRS, Rochester, New York, United States
🇺🇸
UCLA CARE Center CRS, Los Angeles, California, United States

and more 61 locations

Evaluating the Effect of CHanging EnfuvirtidE to Raltegravir in HIV Infected Subjects

Phase 3

Completed

Conditions: HIV Infections

Interventions: Drug: raltegravir

First Posted Date: 2007-09-14

Last Posted Date: 2018-08-07

Lead Sponsor: Kaiser Permanente

Target Recruit Count: 52

Registration Number: NCT00529243

Locations: 🇺🇸
Kaiser Hayward, Hayward, California, United States
🇺🇸
Kaiser Anaheim, Anaheim, California, United States
🇺🇸
Kaiser Panorama City, Panorama City, California, United States

and more 5 locations

Switching From PI to RALtegravir in HIV Stable Patients

Phase 3

Completed

Conditions: HIV Infections

Interventions: Drug: boosted PI
Drug: Raltegravir

First Posted Date: 2007-09-12

Last Posted Date: 2010-03-31

Lead Sponsor: Hospital Clinic of Barcelona

Target Recruit Count: 282

Registration Number: NCT00528892

Locations: 🇪🇸
Hospital Clinic, Barcelona, Spain

Standard Antiretroviral v. Multi-class Therapy in Acutely HIV-1 Infected Antiretroviral-Naïve Subjects (ADARC 2007-01)

Not Applicable

Completed

Conditions: HIV Infections

Interventions: Drug: darunavir 800 mg
Drug: FTC 200 mg/TDF 300mg
Drug: Maraviroc
Drug: Raltegravir
Drug: Ritonavir 100 mg

First Posted Date: 2007-09-06

Last Posted Date: 2015-03-09

Lead Sponsor: Rockefeller University

Target Recruit Count: 40

Registration Number: NCT00525733

Locations: 🇺🇸
Rockefeller University, New York, New York, United States
🇺🇸
The Rockefeller University, New York, New York, United States

RAL-eve Study: Raltegravir Substitution Study

Not Applicable

Completed

Conditions: HIV Infections

First Posted Date: 2007-08-31

Last Posted Date: 2011-11-02

Lead Sponsor: Stanford University

Target Recruit Count: 14

Registration Number: NCT00523237

Locations: 🇺🇸
Stanford University School of Medicine, Stanford, California, United States

DDI HV (ATV - Merck)

Phase 1

Completed

Conditions: HIV Infections

Interventions: Drug: Atazanavir + Raltegravir
Drug: Raltegravir
Drug: Atazanavir

First Posted Date: 2007-08-20

Last Posted Date: 2010-02-04

Lead Sponsor: Bristol-Myers Squibb

Target Recruit Count: 22

Registration Number: NCT00518297

Locations: 🇺🇸
Bristol-Myers Squibb Clinical Pharmacology Unit, Hamilton, New Jersey, United States

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