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

This study has been completed.
Sponsor:
Information provided by:
University of Aarhus
ClinicalTrials.gov Identifier:
NCT00647244
First received: March 26, 2008
Last updated: December 17, 2010
Last verified: December 2010

March 26, 2008
December 17, 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 ] [ Designated as safety issue: Yes ]
  • Levels of renal tubule function markers in blood and urine [ Time Frame: Weeks 0, 12, 24, 48, 96 ] [ Designated as safety issue: Yes ]
  • Bone mass assessed by DEXA [ Time Frame: Weeks 0, 24, 48, 96 ] [ Designated as safety issue: Yes ]
  • Levels of bone turnover markers in blood and urine [ Time Frame: Weeks 0, 12, 24, 48, 96 ] [ Designated as safety issue: Yes ]
  • Insulin resistance [ Time Frame: Weeks 0, 12, 24, 48, 96 ] [ Designated as safety issue: Yes ]
  • Changes in body composition assessed by patient questionnaire and standardized examination by physician [ Time Frame: Weeks 0, 12, 24, 48, 96 ] [ Designated as safety issue: Yes ]
  • Changes in subcutaneous adipose tissue assessed by DEXA [ Time Frame: Week 0, 24, 48, 96 ] [ Designated as safety issue: Yes ]
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 ] [ Designated as safety issue: Yes ]
  • CD-4 cell count [ Time Frame: Weeks 0, 4, 8, 12, 24, 48, 96 ] [ Designated as safety issue: Yes ]
  • Fasting triglycerides, HDL and LDL [ Time Frame: Weeks 0, 12, 24, 48, 96 ] [ Designated as safety issue: Yes ]
  • Development of resistance mutations [ Time Frame: Weeks 0, 12, 24, 48, 96 ] [ Designated as safety issue: Yes ]
  • Development of adverse events and serious adverse events [ Time Frame: Weeks 0, 4, 8, 12, 24, 48, 96 ] [ Designated as safety issue: Yes ]
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: 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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Denmark
 
NCT00647244
SKS-HIV-002, EudraCT2007-004372-39
Yes
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