ClinicalTrials.gov
 Home    Search    Study Topics    Glossary  
 

  Full Text View  
  Tabular View  
  Contacts and Locations  
  No Study Results Posted  
  Related Studies  
Efficacy and Safety of Switching From Retrovir to Tenofovir or Abacavir in HIV-Infected Patients (SWAP)

This study is not yet open for participant recruitment.
Study NCT00647244.   Last updated on March 28, 2008.   Information provided by University of Aarhus

This Tabular View shows the required WHO registration data elements as marked by

Descriptive Information Fields
Brief Title  Efficacy and Safety of Switching From Retrovir to Tenofovir or Abacavir in HIV-Infected Patients
Official Title 
Brief Summary

To evaluate the efficacy and safety of switching from Retrovir to Tenofovir or Abacavir in HIV-infected patients

Detailed Description
Study Phase Phase IV
Study Type  Interventional
Study Design  Treatment, Randomized, Open Label, Parallel Assignment
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 ]
Secondary Outcome Measure  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 ]
Condition  HIV Infections
Intervention  Drug: Tenofovir disoproxil fumarate
Drug: Abacavir
MEDLINE PMIDs
Links
Recruitment Information Fields
Recruitment Status  Not yet recruiting
Enrollment  90
Start Date  April 2008
Completion Date February 2011
Eligibility Criteria 

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
Gender Both
Ages 18 Years and older
Accepts Healthy Volunteers No
Contacts ††
Contact: Alex Lund Laursen, MD, PhD, DmSC     +4589498305     ale@sks.aaa.dk    
Contact: Lars Ostergaard, MD, PhD, DmSC     +4589498300        
Location Countries  Denmark
Administrative Information Fields
NCT ID  NCT00647244
Organization ID SKS-HIV-002
Secondary IDs †† EudraCT2007-004372-39
Study Sponsor  Aarhus University Hospital
Collaborators ††
Investigators 
Information Provided By University of Aarhus
Verification Date March 2008
First Received Date  March 26, 2008
Last Updated Date March 28, 2008

 †    Required WHO trial registration data element.
††   WHO trial registration data element that is required only if it exists.




Links to all studies - primarily for crawlers