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| Sponsor: | ViiV Healthcare |
|---|---|
| Collaborators: |
Shionogi GlaxoSmithKline |
| Information provided by (Responsible Party): | ViiV Healthcare |
| ClinicalTrials.gov Identifier: | NCT00951015 |
Purpose
This Phase IIb study in HIV-infected antiretroviral naive subjects will select an optimal once daily dose of GSK1349572 from a range of doses for future evaluation.
| Condition | Intervention | Phase |
|---|---|---|
|
HIV Infection Infection, Human Immunodeficiency Virus HIV-1 Infection |
Drug: GSK1349572 Drug: efavirenz |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | A Phase IIb Study to Select a Once Daily Dose of GSK1349572 Administered With Either Abacavir/Lamivudine or Tenofovir/Emtricitabine in HIV-1 Infected Antiretroviral Therapy Naive Adult Subjects |
| Enrollment: | 208 |
| Study Start Date: | July 2009 |
| Estimated Study Completion Date: | December 2015 |
| Primary Completion Date: | February 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: 10 mg GSK1349572
subjects will receive GSK1349572 10mg once daily blinded to dose
|
Drug: GSK1349572
investigational HIV-1 integrase inhibitor
|
|
Experimental: 25mg GSK1349572
subjects will receive GSK1349572 25mg once daily blinded to dose
|
Drug: GSK1349572
investigational HIV-1 integrase inhibitor
|
|
Experimental: 50mg GSK1349572
subjects will receive GSK1349572 50mg once daily blinded to dose
|
Drug: GSK1349572
investigational HIV-1 integrase inhibitor
|
|
efavirenz control
efavirenz will serve as the internal control arm
|
Drug: efavirenz
approved therapy for HIV-1 infection, used as an internal study control
Other Names:
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This Phase IIb study in HIV-infected antiretroviral naive adult subjects will include a dose-ranging evaluation of GSK1349572 10mg, 25mg and 50mg once daily blinded doses and a control arm of open label efavirenz 600mg once daily. Background ART for all study subjects will be chosen by the investigators and will be either Truvada or Epzicom/Kivexa. Data from the three doses of GSK1349572 will be compared on the basis of antiviral activity, safety/tolerability and pharmacokinetics over 16-24 weeks.
Several planned interim analyses will evaluate data in real time; any doses considered inferior will be dropped and subjects on those doses of GSK1349572 will have the option to switch to either the highest dose still under investigation or the selected dose. Subjects will be able to remain in the study, unless they reach a stopping criterion, for at least 96 weeks.
ViiV Healthcare is the new sponsor of this study, and GlaxoSmithKline is in the process of updating systems to reflect the change in sponsorship.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Note: Subjects starting abacavir as part of the NRTI backbone must have been screened and be negative for the HLA-B*5701 allele.
Exclusion Criteria:
Contacts and Locations
Show 35 Study Locations| Study Director: | GSK Clinical Trials | ViiV Healthcare |
More Information
| Responsible Party: | ViiV Healthcare |
| ClinicalTrials.gov Identifier: | NCT00951015 History of Changes |
| Other Study ID Numbers: | 112276 |
| Study First Received: | July 30, 2009 |
| Last Updated: | March 29, 2012 |
| Health Authority: | Spain: Agencia Española del Medicamento y Productos Sanitarios Russia: Russian Ministry of Health Germany: Bundesinstitut für Arzneimittel und Medizinprodukte France: Agence Française de Sécurité Sanitaire des Produits de Santé United States: Food and Drug Administration |
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GSK1349572 emtricitabine tenofovir efavirenz abacavir antiretroviral therapy naive |
dose selection integrase inhibitor HIV infection once daily lamivudine |
|
Acquired Immunodeficiency Syndrome HIV Infections Immunologic Deficiency Syndromes Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Slow Virus Diseases Immune System Diseases Lamivudine Efavirenz |
Emtricitabine Integrase Inhibitors Reverse Transcriptase Inhibitors Nucleic Acid Synthesis Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Anti-Retroviral Agents Antiviral Agents Anti-Infective Agents Therapeutic Uses Anti-HIV Agents |