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| Sponsor: | Aarhus University Hospital |
|---|---|
| Information provided by: | University of Aarhus |
| ClinicalTrials.gov Identifier: | NCT00647244 |
Purpose
To evaluate the efficacy and safety of switching from Retrovir to Tenofovir or Abacavir in HIV-infected patients
| Condition | Intervention | Phase |
|---|---|---|
|
HIV Infections |
Drug: Tenofovir disoproxil fumarate Drug: Abacavir |
Phase IV |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Open Label, Parallel Assignment |
| Official Title: | Efficacy and Safety of Switching From AZT to Tenofovir |
| Estimated Enrollment: | 90 |
| Study Start Date: | June 2008 |
| Estimated Study Completion Date: | February 2011 |
| Estimated Primary Completion Date: | October 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
1: Active Comparator
Tenofovir
|
Drug: Tenofovir disoproxil fumarate
Tenofovir disoproxil 245 mg oral tablet once daily
|
|
2: Active Comparator
Abacavir
|
Drug: Abacavir
Abacavir 300 mg oral tablet twice daily
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Alex Lund Laursen, MD, PhD, DmSC | +4589498305 | ale@sks.aaa.dk |
| Contact: Lars Ostergaard, MD, PhD, DmSC | +4589498300 |
| Denmark | |
| Aarhus University Hospital | Recruiting |
| Århus N, Denmark, 8200 | |
| Contact: Alex Lund Laursen, MD, PhD, DmSC +4589498305 ale@sks.aaa.dk | |
| Principal Investigator: Alex Lund Laursen, MD, PhD, DmSC | |
| Sub-Investigator: Lars Ostergaard, MD, PhD, DmSC | |
| Sub-Investigator: Carsten Schade Larsen, MD, PhD, DmSC | |
More Information
| Responsible Party: | Department of Infectious Diseases, Aarhus University Hospital, Denmark ( Alex Lund Laursen, MD, PhD, DmSC ) |
| Study ID Numbers: | SKS-HIV-002, EudraCT2007-004372-39 |
| Study First Received: | March 26, 2008 |
| Last Updated: | February 19, 2009 |
| ClinicalTrials.gov Identifier: | NCT00647244 History of Changes |
| Health Authority: | Denmark: Danish Medicines Agency |
|
Tenofovir Abacavir Antiretroviral therapy HIV Nucleoside analogue reverse transcriptase inhibitor |
|
Anti-Infective Agents Sexually Transmitted Diseases, Viral Slow Virus Diseases Molecular Mechanisms of Pharmacological Action Infection Reverse Transcriptase Inhibitors Anti-Retroviral Agents Therapeutic Uses Tenofovir Abacavir Retroviridae Infections Nucleic Acid Synthesis Inhibitors Tenofovir disoproxil |
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 |