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Sponsored by: |
Boehringer Ingelheim Pharmaceuticals |
Information provided by: | Boehringer Ingelheim Pharmaceuticals |
ClinicalTrials.gov Identifier: | NCT00389207 |
Primary purpose of this study is to compare the efficacy and safety of two different nevirapine (Vir amune) dosing regimens (once daily and twice daily application) and of atazanavir/ritonavir (Reyataz
/Norvir), all on an emtricitabine/tenofovir DF (Truvada) background. Patients will receive either nevirapine (NVP) 200 mg twice daily, or NVP 400 mg once daily, or riton avir-boosted atazanavir (ATZ/r), all in combination with emtricitabine (FTC) and tenofovir DF (TDF).
All patients receiving NVP will start at 200 mg QD for 2 weeks, because it has been demonstrated th at this lead-in dosing regimen reduces the frequency of NVP-induced rash. At Visit 3 (Week 2), patie nts increase the NVP dose to either 200 mg BID or to 400 mg QD. Patients receiving ATZ/r will be tre ated with ATZ 300 mg once daily, boosted by 100 mg ritonavir (RTV) once daily. Background antiretrov iral therapy for all patients consists of one tablet of Truvada. Treatment duration is 48 weeks (pri mary endpoint) with an extension to 144 weeks. Patients may also participate in the metabolic sub-st udy, comparing NVP and ATZ/r for signs and symptoms of lypodystrophy and serum lipid/glycaemic abnor malities.
Condition | Intervention | Phase |
HIV Infections |
Drug: Atazanavir/Ritonavir Drug: Emtricitabine/Tenofovir DF Drug: Nevirapine |
Phase III |
MedlinePlus related topics: | AIDS |
ChemIDplus related topics: | Ritonavir Nevirapine Atazanavir sulfate BMS 232632 Tenofovir Tenofovir disoproxil Tenofovir Disoproxil Fumarate Lipids |
Study Type: | Interventional |
Study Design: | Treatment, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Randomized, Open Label Study Evaluating the Lipid Profile Difference and Efficacy of a Combined Therapy Including Tenofovir, Emtricitabine + Atazanavir / r or NVP in Naive HIV - 1 Infected Patients. |
Estimated Enrollment: | 561 |
Study Start Date: | October 2006 |
Estimated Primary Completion Date: | December 2010 (Final data collection date for primary outcome measure) |
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Inclusion Criteria:
Exclusion Criteria:
Exclusion Criteria:
Female patients of child-bearing potential who:
Show 59 Study Locations |
Boehringer Ingelheim Pharmaceuticals |
Study Chair: | Boehringer Ingelheim | Boehringer Ingelheim Pharmaceuticals |
Responsible Party: | Boehringer Ingelheim ( Boehringer Ingelheim, Study Chair ) |
Study ID Numbers: | 1100.1470, EUDRACT 2005-004330-40 |
First Received: | October 17, 2006 |
Last Updated: | July 30, 2008 |
ClinicalTrials.gov Identifier: | NCT00389207 |
Health Authority: | Spain: Agencia Espanola del Medicamento y Productos Sanitarios; Germany: Federal Institute for Drugs and Medical Devices; United States: Food and Drug Administration; Great Britain: MHRA; Argentina: A.N.M.A.T. (Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica); Poland: Urzad Rejestracji Produktow Leczniczych; Romania: National Medicines Agency, Bucharest; Italy: Comitato Etico dell'Azienda Osp. Riuniti di Bergamo - Bergamo; Mexico: Comision Federal para la Proteccion contra Riesgos Sanitarios (COFEPRIS); Portugal: INFARMED - Instituto Nacional da Farmacia e do Medicamento; Switzerland: Swissmedic Schweizerisches Heilmittelinstitut (Swiss Agency for Therapeutic Products) |
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