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Sponsors and Collaborators: |
The National Centre in HIV Epidemiology and Clinical Research The University of New South Wales Gilead Sciences |
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Information provided by: | The National Centre in HIV Epidemiology and Clinical Research |
ClinicalTrials.gov Identifier: | NCT00335322 |
In treatment naïve HIV infected subjects, combination antiretroviral therapy including efavirenz combined with tenofovir and emtricitabine will offer non-inferior antiretroviral efficacy over 48 weeks, compared to either atazanavir boosted with ritonavir combined with tenofovir and emtricitabine or tenofovir and emtricitabine combined with zidovudine and abacavir, as assessed by change from baseline plasma HIV-1 RNA viral load.
Condition | Intervention | Phase |
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Human Immunodeficiency Virus (HIV) |
Drug: Truvada (fixed dose combination of tenofovir + emtricitabine) + Stocrin (efavirenz) Drug: Truvada (fixed dose combination of tenofovir + emtricitabine)+ ritonavir/atazanavir (r/ATV) Drug: Truvada (fixed dose combination of tenofovir + emtricitabine) + zidovudine (ZDV) + abacavir (ABC) |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Randomised, Open-Label, 96-Week Study Comparing the Safety and Efficacy of Three Different Combination Antiretroviral Regimens as Initial Therapy for HIV Infection. |
Estimated Enrollment: | 300 |
Study Start Date: | November 2006 |
Estimated Study Completion Date: | August 2009 |
The primary objective of this study is to compare the virological efficacy, as measured by the time-weighted mean change from baseline plasma HIV-RNA, and safety, of three strategic regimens of initial antiretroviral therapy (ART) containing a fixed dose formulation of tenofovir and emtricitabine, with either efavirenz or ritonavir boosted atazanavir or zidovudine plus abacavir. (Primary comparisons are regimen I versus II and I versus III as described below).
I. tenofovir (TDF) + emtricitabine (FTC) + efavirenz (EFV) II. tenofovir (TDF) + emtricitabine (FTC) + ritonavir/atazanavir (r/ATV) III. tenofovir (TDF) + emtricitabine (FTC) + zidovudine (ZDV) + abacavir (ABC)
Secondary objectives of this study will be to undertake a range of analyses including but not limited to the following,
Ages Eligible for Study: | 16 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
The following laboratory variables,
Contact: Rebekah Puls, BSc PhD | +61 2 9385 0900 | rpuls@nchecr.unsw.edu.au |
Contact: Sean Emery, BSc(Hons), PhD | +61 2 9385 0900 | semery@nchecr.unsw.edu.au |
Principal Investigator: | David A Cooper, AO DSc MD FRACP FRCPA FRCP | The National Centre in HIV Epidemiology and Clinical Research |
Study ID Numbers: | NCHECR-ALTAIR |
Study First Received: | June 8, 2006 |
Last Updated: | June 8, 2006 |
ClinicalTrials.gov Identifier: | NCT00335322 |
Health Authority: | Australia: Department of Health and Ageing Therapeutic Goods Administration |
Human Immunodeficiency Virus (HIV) |
Efavirenz Sexually Transmitted Diseases, Viral Acquired Immunodeficiency Syndrome Zidovudine Atazanavir Immunologic Deficiency Syndromes Virus Diseases Emtricitabine |
HIV Infections Ritonavir Sexually Transmitted Diseases Tenofovir Abacavir Retroviridae Infections Tenofovir disoproxil |
Anti-Infective Agents RNA Virus Infections Anti-HIV Agents Slow Virus Diseases Immune System Diseases Molecular Mechanisms of Pharmacological Action Enzyme Inhibitors |
Antiviral Agents Pharmacologic Actions Reverse Transcriptase Inhibitors Anti-Retroviral Agents Therapeutic Uses Lentivirus Infections Nucleic Acid Synthesis Inhibitors |