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Efficacy and Safety of Switching From Retrovir to Tenofovir or Abacavir in HIV-infected Patients (SWAP)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00647244
First Posted: March 31, 2008
Last Update Posted: December 20, 2010
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
University of Aarhus
March 26, 2008
March 31, 2008
December 20, 2010
June 2008
August 2010   (Final data collection date for primary outcome measure)
  • Renal function measured by Cystatin-C and creatinine clearance [ Time Frame: Weeks 0, 4, 8, 12, 24, 24, 48, 96 ]
  • Levels of renal tubule function markers in blood and urine [ Time Frame: Weeks 0, 12, 24, 48, 96 ]
  • Bone mass assessed by DEXA [ Time Frame: Weeks 0, 24, 48, 96 ]
  • Levels of bone turnover markers in blood and urine [ Time Frame: Weeks 0, 12, 24, 48, 96 ]
  • Insulin resistance [ Time Frame: Weeks 0, 12, 24, 48, 96 ]
  • Changes in body composition assessed by patient questionnaire and standardized examination by physician [ Time Frame: Weeks 0, 12, 24, 48, 96 ]
  • Changes in subcutaneous adipose tissue assessed by DEXA [ Time Frame: Week 0, 24, 48, 96 ]
Same as current
Complete list of historical versions of study NCT00647244 on ClinicalTrials.gov Archive Site
  • Patients with viral load < 40 copies/ml [ Time Frame: Weeks 0, 4, 8, 12, 24, 48, 96 ]
  • CD-4 cell count [ Time Frame: Weeks 0, 4, 8, 12, 24, 48, 96 ]
  • Fasting triglycerides, HDL and LDL [ Time Frame: Weeks 0, 12, 24, 48, 96 ]
  • Development of resistance mutations [ Time Frame: Weeks 0, 12, 24, 48, 96 ]
  • Development of adverse events and serious adverse events [ Time Frame: Weeks 0, 4, 8, 12, 24, 48, 96 ]
Same as current
Not Provided
Not Provided
 
Efficacy and Safety of Switching From Retrovir to Tenofovir or Abacavir in HIV-infected Patients
Efficacy and Safety of Switching From AZT to Tenofovir
To evaluate the efficacy and safety of switching from Retrovir to Tenofovir or Abacavir in HIV-infected patients
Not Provided
Interventional
Phase 4
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
HIV Infections
  • Drug: Tenofovir disoproxil fumarate
    Tenofovir disoproxil 245 mg oral tablet once daily
  • Drug: Abacavir
    Abacavir 300 mg oral tablet twice daily
  • Active Comparator: 1
    Tenofovir
    Intervention: Drug: Tenofovir disoproxil fumarate
  • Active Comparator: 2
    Abacavir
    Intervention: Drug: Abacavir

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
40
August 2010
August 2010   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • HIV-infection with undetectable viral load
  • 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:

  • Prior treatment with abacavir or tenofovir
  • 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
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Denmark
 
 
NCT00647244
SKS-HIV-002
EudraCT2007-004372-39
Yes
Not Provided
Not Provided
Alex Lund Laursen, MD, PhD, DmSC, Department of Infectious Diseases, Aarhus University Hospital, Denmark
Aarhus University Hospital
Not Provided
Not Provided
University of Aarhus
December 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP