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

HIV Infections Clinical Trial

— SWAP  

Official title:

Efficacy and Safety of Switching From AZT to Tenofovir

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00647244
• Other study ID #: SKS-HIV-002
• Secondary ID: EudraCT2007-0043
• Status: Completed
• Phase: Phase 4
• First received: March 26, 2008
• Last updated: December 17, 2010
• Start date: June 2008
• Est. completion date: August 2010

Study information

• Verified date: December 2010
• Source: University of Aarhus
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: Danish Medicines Agency
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: August 2010
• Est. primary completion date: August 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• HIV Infections

Intervention

Drug:
• Tenofovir disoproxil fumarate
Tenofovir disoproxil 245 mg oral tablet once daily
• Abacavir
Abacavir 300 mg oral tablet twice daily

Locations

Country	Name	City	State
Denmark	Aarhus University Hospital	Århus N

Sponsors (1)

Lead Sponsor	Collaborator
Aarhus University Hospital

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Renal function measured by Cystatin-C and creatinine clearance		Weeks 0, 4, 8, 12, 24, 24, 48, 96	Yes
Primary	Levels of renal tubule function markers in blood and urine		Weeks 0, 12, 24, 48, 96	Yes
Primary	Bone mass assessed by DEXA		Weeks 0, 24, 48, 96	Yes
Primary	Levels of bone turnover markers in blood and urine		Weeks 0, 12, 24, 48, 96	Yes
Primary	Insulin resistance		Weeks 0, 12, 24, 48, 96	Yes
Primary	Changes in body composition assessed by patient questionnaire and standardized examination by physician		Weeks 0, 12, 24, 48, 96	Yes
Primary	Changes in subcutaneous adipose tissue assessed by DEXA		Week 0, 24, 48, 96	Yes
Secondary	Patients with viral load < 40 copies/ml		Weeks 0, 4, 8, 12, 24, 48, 96	Yes
Secondary	CD-4 cell count		Weeks 0, 4, 8, 12, 24, 48, 96	Yes
Secondary	Fasting triglycerides, HDL and LDL		Weeks 0, 12, 24, 48, 96	Yes
Secondary	Development of resistance mutations		Weeks 0, 12, 24, 48, 96	Yes
Secondary	Development of adverse events and serious adverse events		Weeks 0, 4, 8, 12, 24, 48, 96	Yes