Efficacy and Safety of Switching From Retrovir to Tenofovir or Abacavir in HIV-infected Patients
NCT ID: NCT00647244
Last Updated: 2010-12-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE4
40 participants
INTERVENTIONAL
2008-06-30
2010-08-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
1
Tenofovir
Tenofovir disoproxil fumarate
Tenofovir disoproxil 245 mg oral tablet once daily
2
Abacavir
Abacavir
Abacavir 300 mg oral tablet twice daily
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Tenofovir disoproxil fumarate
Tenofovir disoproxil 245 mg oral tablet once daily
Abacavir
Abacavir 300 mg oral tablet twice daily
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Antiretroviral treatment including Retrovir for more than three months
* If fertile female: Negative pregnancy test and use of safe contraception
* Negative HBs-antigen titer
Exclusion Criteria
* Resistance towards abacavir or tenofovir
* Tissue type HLA-B5701
* Renal disease
* Diabetes Mellitus
* Osteoporosis
* Pregnant or lactating subjects
* Intravenous drug abuse
* Hypersensitivity towards drugs or active ingredient used
* ALAT \> 5 times upper normal level
* Current alcohol or substance abuse judged by the Investigator to potentially interfere with subject compliance
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Aarhus University Hospital
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Department of Infectious Diseases, Aarhus University Hospital, Denmark
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Aarhus University Hospital
Århus N, , Denmark
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Rasmussen TA, Jensen D, Tolstrup M, Nielsen US, Erlandsen EJ, Birn H, Ostergaard L, Langdahl BL, Laursen AL. Comparison of bone and renal effects in HIV-infected adults switching to abacavir or tenofovir based therapy in a randomized trial. PLoS One. 2012;7(3):e32445. doi: 10.1371/journal.pone.0032445. Epub 2012 Mar 29.
Rasmussen TA, Tolstrup M, Melchjorsen J, Frederiksen CA, Nielsen US, Langdahl BL, Ostergaard L, Laursen AL. Evaluation of cardiovascular biomarkers in HIV-infected patients switching to abacavir or tenofovir based therapy. BMC Infect Dis. 2011 Oct 4;11:267. doi: 10.1186/1471-2334-11-267.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
EudraCT2007-004372-39
Identifier Type: -
Identifier Source: secondary_id
SKS-HIV-002
Identifier Type: -
Identifier Source: org_study_id