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| Sponsor: | GlaxoSmithKline |
|---|---|
| Collaborator: |
Shionogi |
| Information provided by: | GlaxoSmithKline |
| 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 HIV-1 Infection |
Drug: efavirenz Drug: GSK1349572 |
Phase II |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Parallel Assignment, Safety/Efficacy Study |
| 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 |
| Estimated Enrollment: | 200 |
| Study Start Date: | July 2009 |
| Estimated Study Completion Date: | January 2015 |
| Estimated Primary Completion Date: | April 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
25mg: Experimental
subjects will receive GSK1349572 25mg once daily blinded to dose
|
Drug: GSK1349572
investigational HIV-1 integrase inhibitor
|
|
10 mg: Experimental
subjects will receive GSK1349572 10mg 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
|
|
50mg: Experimental
subjects will receive GSK1349572 50mg once daily blinded to dose
|
Drug: GSK1349572
investigational HIV-1 integrase inhibitor
|
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.
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 36 Study Locations| Study Director: | GSK Clinical Trials | GlaxoSmithKline |
More Information
| Responsible Party: | GSK ( Study Director ) |
| Study ID Numbers: | 112276 |
| Study First Received: | July 30, 2009 |
| Last Updated: | January 21, 2010 |
| ClinicalTrials.gov Identifier: | NCT00951015 History of Changes |
| Health Authority: | France: Agence Française de Sécurité Sanitaire des Produits de Santé; Germany: Bundesinstitut für Arzneimittel und Medizinprodukte; Russia: Russian Ministry of Health; Spain: Agencia Española del Medicamento y Productos Sanitarios; United States: Food and Drug Administration |
|
HIV infection GSK1349572 integrase inhibitor abacavir lamivudine tenofovir |
emtricitabine efavirenz antiretroviral therapy naive dose selection once daily |
|
Communicable Diseases Anti-Infective Agents Sexually Transmitted Diseases, Viral Slow Virus Diseases Molecular Mechanisms of Pharmacological Action Infection Reverse Transcriptase Inhibitors Emtricitabine Anti-Retroviral Agents Integrase Inhibitors Therapeutic Uses Retroviridae Infections Nucleic Acid Synthesis Inhibitors |
Efavirenz RNA Virus Infections Anti-HIV Agents Immune System Diseases Acquired Immunodeficiency Syndrome Enzyme Inhibitors Antiviral Agents Immunologic Deficiency Syndromes Pharmacologic Actions Virus Diseases HIV Infections Sexually Transmitted Diseases Lentivirus Infections |