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

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

Official Title
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Efficacy and Safety of Switching From AZT to Tenofovir

Conditions
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HIV Infections

Intervention / Treatment
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* Drug: Tenofovir disoproxil fumarate
* Drug: Abacavir


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br>Tenofovir | Drug: Tenofovir disoproxil fumarate<br>* Tenofovir disoproxil 245 mg oral tablet once daily<br>|
| Active Comparator: 2<br>Abacavir | Drug: Abacavir<br>* Abacavir 300 mg oral tablet twice daily<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Tenofovir, Abacavir, Antiretroviral therapy, HIV, Nucleoside analogue reverse transcriptase inhibitor