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Sponsored by: |
Gilead Sciences |
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Information provided by: | Gilead Sciences |
ClinicalTrials.gov Identifier: | NCT00323544 |
This study will investigate whether the simplified regimen of a once daily fixed dose combination of Truvada (emtricitabine and tenofovir disoproxil fumarate [DF]) will be associated with a reduced rate of adverse events, seen with long term use of antiretrovirals, as well as improved adherence compared to a twice daily fixed dose combination of Combivir.
Condition | Intervention | Phase |
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HIV Infections |
Drug: zidovudine and lamivudine (Combivir®) Drug: emtricitabine and tenofovir DF |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety Study |
Official Title: | A Phase 3, Open Label, Randomised, Parallel Group Study to Compare the Effect on Prevention and Resolution of Treatment Related Adverse Events of a Simplified, Once Daily Regimen of a Fixed Dose Combination Tablet of Emtricitabine and Tenofovir DF Versus Twice Daily co-Formulated Zidovudine and Lamivudine (Combivir®) or Zidovudine and Lamivudine, in Virologically Suppressed, HIV Infected Patients Taking Efavirenz |
Estimated Enrollment: | 220 |
Study Start Date: | October 2004 |
Study Completion Date: | October 2007 |
Primary Completion Date: | June 2007 (Final data collection date for primary outcome measure) |
The success of HAART is largely dependant on an individual's ability to adhere strictly to an antiretroviral regimen. Regimen characteristics that affect adherence include dosing frequency and pill burden. Several studies have shown improved adherence with lower pill burden and a meta-analysis of the virological outcome in relation to pill burden has shown a significant correlation between lower pill burden and better virological outcome. A systematic review of studies across a range of medical specialties demonstrated that once daily therapy improves adherence relative to more frequent dosing although statistical significance was not demonstrated relative to twice daily regimens.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Patients receiving ongoing therapy with any of the following (administration of any of the following medications must be discontinued at least 30 days prior to the Baseline visit and for the duration of the study period):
Responsible Party: | Gilead Sciences ( Cham Herath ) |
Study ID Numbers: | GS-MC-164-0111 |
Study First Received: | May 5, 2006 |
Last Updated: | June 30, 2008 |
ClinicalTrials.gov Identifier: | NCT00323544 |
Health Authority: | United Kingdom: Medicines and Healthcare Products Regulatory Agency |
HIV 1 HIV 1 infection |
Efavirenz Sexually Transmitted Diseases, Viral Acquired Immunodeficiency Syndrome Zidovudine Lamivudine Immunologic Deficiency Syndromes Virus Diseases |
Emtricitabine HIV Infections Sexually Transmitted Diseases Tenofovir Retroviridae Infections Tenofovir disoproxil |
Antimetabolites Anti-Infective Agents Communicable Diseases RNA Virus Infections Anti-HIV Agents Slow Virus Diseases Immune System Diseases Molecular Mechanisms of Pharmacological Action Enzyme Inhibitors |
Infection Antiviral Agents Pharmacologic Actions Reverse Transcriptase Inhibitors Anti-Retroviral Agents Therapeutic Uses Lentivirus Infections Nucleic Acid Synthesis Inhibitors |