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Last Updated: January 25, 2022

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CLINICAL TRIALS PROFILE FOR ISENTRESS

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All Clinical Trials for Isentress

Trial ID Title Status Sponsor Phase Start Date Summary
NCT00485264 ↗ Safety and Pharmacokinetics (PK) of Raltegravir in HIV (Human Immunodeficiency Virus)-Infected Children and Adolescents Completed Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) Phase 1/Phase 2 2007-09-17 Integrase is 1 of 3 HIV (Human Immunodeficiency Virus)-1 enzymes required for viral replication. Raltegravir is a drug that prevents integrase from working properly. This drug has been tested for safety and efficacy in adults, but this is the first study to examine raltegravir in children and adolescents. The purpose of this study was to determine the appropriate dose for raltegravir across the pediatric age range from 4 weeks to 18 years of age, by acquiring short and long term safety data, intensive and population pharmacokinetic (PK) data, and efficacy experience with raltegravir in HIV-infected children and adolescents.
NCT00485264 ↗ Safety and Pharmacokinetics (PK) of Raltegravir in HIV (Human Immunodeficiency Virus)-Infected Children and Adolescents Completed National Institute of Allergy and Infectious Diseases (NIAID) Phase 1/Phase 2 2007-09-17 Integrase is 1 of 3 HIV (Human Immunodeficiency Virus)-1 enzymes required for viral replication. Raltegravir is a drug that prevents integrase from working properly. This drug has been tested for safety and efficacy in adults, but this is the first study to examine raltegravir in children and adolescents. The purpose of this study was to determine the appropriate dose for raltegravir across the pediatric age range from 4 weeks to 18 years of age, by acquiring short and long term safety data, intensive and population pharmacokinetic (PK) data, and efficacy experience with raltegravir in HIV-infected children and adolescents.
NCT00525733 ↗ Standard Antiretroviral v. Multi-class Therapy in Acutely HIV-1 Infected Antiretroviral-Naïve Subjects (ADARC 2007-01) Completed Aaron Diamond AIDS Research Center N/A 2007-10-01 The researchers are involved in a phase II, randomized, two-arm study, comparing the efficacy, safety, and tolerability of open-label ritonavir (RTV)-enhanced darunavir with Truvada to a 5-drug multi-class regimen including truvada, darunavir/ritonavir/maraviroc/and raltegravir on acutely HIV-1-infected, antiretroviral (ARV) drug-naïve men and women. Subjects will participate for at least 60 weeks and up to 96 weeks if in the opinion of the investigator and patient that continued therapy is in the patient's best interest. Hypotheses: - Multi-class antiretroviral therapy (ART) is superior to RTV-enhanced ATV in combination with Emtricitabine/Tenofovir DF (FTC/TDF) with respect to suppression of viral replication. - Multi-class ART is superior to RTV-enhanced ATV in combination with FTC/TDF with respect to immune reconstitution in peripheral blood and in the gastrointestinal mucosa. - Multi-class ART is equivalent to RTV-enhanced ATV in combination with FTC/TDF with respect to tolerability.
NCT00525733 ↗ Standard Antiretroviral v. Multi-class Therapy in Acutely HIV-1 Infected Antiretroviral-Naïve Subjects (ADARC 2007-01) Completed Merck Sharp & Dohme Corp. N/A 2007-10-01 The researchers are involved in a phase II, randomized, two-arm study, comparing the efficacy, safety, and tolerability of open-label ritonavir (RTV)-enhanced darunavir with Truvada to a 5-drug multi-class regimen including truvada, darunavir/ritonavir/maraviroc/and raltegravir on acutely HIV-1-infected, antiretroviral (ARV) drug-naïve men and women. Subjects will participate for at least 60 weeks and up to 96 weeks if in the opinion of the investigator and patient that continued therapy is in the patient's best interest. Hypotheses: - Multi-class antiretroviral therapy (ART) is superior to RTV-enhanced ATV in combination with Emtricitabine/Tenofovir DF (FTC/TDF) with respect to suppression of viral replication. - Multi-class ART is superior to RTV-enhanced ATV in combination with FTC/TDF with respect to immune reconstitution in peripheral blood and in the gastrointestinal mucosa. - Multi-class ART is equivalent to RTV-enhanced ATV in combination with FTC/TDF with respect to tolerability.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Isentress

Condition Name

Condition Name for Isentress
Intervention Trials
HIV Infections 33
HIV 17
HIV Infection 12
HIV-1 Infection 6
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Condition MeSH

Condition MeSH for Isentress
Intervention Trials
HIV Infections 56
Acquired Immunodeficiency Syndrome 15
Infections 14
Infection 11
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Clinical Trial Locations for Isentress

Trials by Country

Trials by Country for Isentress
Location Trials
United States 96
Brazil 15
Canada 15
South Africa 14
France 10
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Trials by US State

Trials by US State for Isentress
Location Trials
California 12
New York 7
Massachusetts 7
Florida 7
North Carolina 7
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Clinical Trial Progress for Isentress

Clinical Trial Phase

Clinical Trial Phase for Isentress
Clinical Trial Phase Trials
Phase 4 30
Phase 3 12
Phase 2/Phase 3 3
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Clinical Trial Status

Clinical Trial Status for Isentress
Clinical Trial Phase Trials
Completed 67
Unknown status 9
Terminated 5
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Clinical Trial Sponsors for Isentress

Sponsor Name

Sponsor Name for Isentress
Sponsor Trials
Merck Sharp & Dohme Corp. 47
National Institute of Allergy and Infectious Diseases (NIAID) 7
Radboud University 5
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Sponsor Type

Sponsor Type for Isentress
Sponsor Trials
Other 117
Industry 69
NIH 13
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