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

Phase 4

Completed

• Conditions: HIV Infections
• Interventions: Drug: Tenofovir disoproxil fumarate; Drug: Abacavir

• Registration Number: NCT00647244
• Lead Sponsor: Aarhus University Hospital

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2008-03-26
• Study First Submitted QC: 2008-03-28
• Study First Posted: 2008-03-31
• Study Start: 2008-06
• Primary Completion: 2010-08
• Study Completion: 2010-08
• Status Verified: 2010-12
• Last Update Submitted: 2010-12-17
• Last Update Posted: 2010-12-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	Tenofovir disoproxil fumarate	Tenofovir
2	Abacavir	Abacavir

Primary Outcome Measures

Name	Time	Method
Renal function measured by Cystatin-C and creatinine clearance	Weeks 0, 4, 8, 12, 24, 24, 48, 96
Levels of renal tubule function markers in blood and urine	Weeks 0, 12, 24, 48, 96
Bone mass assessed by DEXA	Weeks 0, 24, 48, 96
Levels of bone turnover markers in blood and urine	Weeks 0, 12, 24, 48, 96
Insulin resistance	Weeks 0, 12, 24, 48, 96
Changes in body composition assessed by patient questionnaire and standardized examination by physician	Weeks 0, 12, 24, 48, 96
Changes in subcutaneous adipose tissue assessed by DEXA	Week 0, 24, 48, 96

Secondary Outcome Measures

Name	Time	Method
Patients with viral load < 40 copies/ml	Weeks 0, 4, 8, 12, 24, 48, 96
CD-4 cell count	Weeks 0, 4, 8, 12, 24, 48, 96
Fasting triglycerides, HDL and LDL	Weeks 0, 12, 24, 48, 96
Development of resistance mutations	Weeks 0, 12, 24, 48, 96
Development of adverse events and serious adverse events	Weeks 0, 4, 8, 12, 24, 48, 96

Trial Locations

Locations (1)

Aarhus University Hospital; 🇩🇰 Århus N, Denmark