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Generated: December 19, 2018

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CLINICAL TRIALS PROFILE FOR ISENTRESS

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Clinical Trials for Isentress

Trial ID Title Status Sponsor Phase Summary
NCT00485264 Safety and Pharmacokinetics (PK) of Raltegravir in HIV (Human Immunodeficiency Virus)-Infected Children and Adolescents Active, not recruiting Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) Phase 1/Phase 2 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 Active, not recruiting National Institute of Allergy and Infectious Diseases (NIAID) Phase 1/Phase 2 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.
NCT00564772 Raltegravir Kaletra Pharmacokinetics Completed Allina Hospitals and Clinics Phase 4 This will be an open-label, 3-period, fixed sequence study in young, healthy, male and female subjects of the pharmacokinetic interaction between raltegravir and Kaletra.
NCT00624195 Clinical Trial of CNS-targeted HAART (CIT2) Completed National Institute of Mental Health (NIMH) Phase 2/Phase 3 CIT2 is a strategy for targeting HAART (Highly Active Antiretroviral Therapy) to the CNS (Central Nervous System) in patients with HIV associated neurocognitive impairment (HNCI). The primary goal of this study is to evaluate the effectiveness of CNS-targeted (CNS-T) as compared to non-CNS-targeted (non-CNS-T) HAART in treating HNCI globally and in different domains of functioning known to be affected by HIV. It is hypothesized that participants in the CNS-T arm will have greater improvement in neurocognitive functioning than those in the non-CNS-T arm. The secondary goal of the study is to compare participants assigned to CNS-T and non-CNS-T HAART on measures of CNS and systemic HIV suppression (undetectable CSF and plasma VL). It is also hypothesized that although CSF viral suppression will be more frequent in the CNS-T arm, plasma viral suppression will be similar in the two treatment arms.
NCT00624195 Clinical Trial of CNS-targeted HAART (CIT2) Completed National Institutes of Health (NIH) Phase 2/Phase 3 CIT2 is a strategy for targeting HAART (Highly Active Antiretroviral Therapy) to the CNS (Central Nervous System) in patients with HIV associated neurocognitive impairment (HNCI). The primary goal of this study is to evaluate the effectiveness of CNS-targeted (CNS-T) as compared to non-CNS-targeted (non-CNS-T) HAART in treating HNCI globally and in different domains of functioning known to be affected by HIV. It is hypothesized that participants in the CNS-T arm will have greater improvement in neurocognitive functioning than those in the non-CNS-T arm. The secondary goal of the study is to compare participants assigned to CNS-T and non-CNS-T HAART on measures of CNS and systemic HIV suppression (undetectable CSF and plasma VL). It is also hypothesized that although CSF viral suppression will be more frequent in the CNS-T arm, plasma viral suppression will be similar in the two treatment arms.
NCT00624195 Clinical Trial of CNS-targeted HAART (CIT2) Completed University of California, San Diego Phase 2/Phase 3 CIT2 is a strategy for targeting HAART (Highly Active Antiretroviral Therapy) to the CNS (Central Nervous System) in patients with HIV associated neurocognitive impairment (HNCI). The primary goal of this study is to evaluate the effectiveness of CNS-targeted (CNS-T) as compared to non-CNS-targeted (non-CNS-T) HAART in treating HNCI globally and in different domains of functioning known to be affected by HIV. It is hypothesized that participants in the CNS-T arm will have greater improvement in neurocognitive functioning than those in the non-CNS-T arm. The secondary goal of the study is to compare participants assigned to CNS-T and non-CNS-T HAART on measures of CNS and systemic HIV suppression (undetectable CSF and plasma VL). It is also hypothesized that although CSF viral suppression will be more frequent in the CNS-T arm, plasma viral suppression will be similar in the two treatment arms.
Trial ID Title Status Sponsor Phase Summary

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Clinical Trial Conditions for Isentress

Condition Name

Condition Name for Isentress
Intervention Trials
HIV Infections 16
HIV Infection 7
HIV 5
Human Immunodeficiency Virus 3
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Condition MeSH

Condition MeSH for Isentress
Intervention Trials
HIV Infections 28
Acquired Immunodeficiency Syndrome 10
Infection 6
Communicable Diseases 5
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Clinical Trial Locations for Isentress

Trials by Country

Trials by Country for Isentress
Location Trials
United States 56
Brazil 7
France 6
Canada 5
Spain 3
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Trials by US State

Trials by US State for Isentress
Location Trials
California 6
North Carolina 4
New York 4
Florida 4
Illinois 3
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Clinical Trial Progress for Isentress

Clinical Trial Phase

Clinical Trial Phase for Isentress
Clinical Trial Phase Trials
Phase 4 12
Phase 3 9
Phase 2/Phase 3 2
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Clinical Trial Status

Clinical Trial Status for Isentress
Clinical Trial Phase Trials
Completed 23
Unknown status 7
Not yet recruiting 3
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Clinical Trial Sponsors for Isentress

Sponsor Name

Sponsor Name for Isentress
Sponsor Trials
Merck Sharp & Dohme Corp. 21
National Institute of Allergy and Infectious Diseases (NIAID) 3
Abbott 3
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Sponsor Type

Sponsor Type for Isentress
Sponsor Trials
Other 40
Industry 32
NIH 7
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Serving hundreds of leading biopharmaceutical companies globally:

Citi
Fish and Richardson
Boehringer Ingelheim
Express Scripts
Healthtrust
Teva
Cerilliant
QuintilesIMS
Covington

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