A randomised, open label, phase IV comparative study to determine the effects on renal function of continuing treatment with tenofovir versus replacement with abacavir in HIV positive persons

INTERVENTION: Trade Name: Ziagen Product Name: Ziagen Product Code: Not appllicable Pharmaceutical Form: Film‐coated tablet Other descriptive name: Abacavir Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 300‐ Trade Name: Viread Product Name: Viread Product Code: Not applicable Pharmaceutical Form: Film‐coated tablet Other descriptive name: Tenofovir disproxil Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 245 ‐ Trade Name: Truvada Product Name: Truvada Product Code: Not appilcable Pharmaceutical Form: Film‐coated tablet Other descriptive name: Tenofovir Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 300‐ Other descriptive name: Emtricitabine Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 200‐ Trade Name: Kivexa Product Name: Kivexa Product Code: Not applicable Pharmaceutical Form: Film‐coated tablet Other descriptive name: Abacavir Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 600‐ Other descriptive name: Lamivudine Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 300‐ CONDITION: HIV PRIMARY OUTCOME: Main Objective: To determine any differences in renal function in patients who continue treatment with tenofovir versus those whose tenofovir is replaced with abacavir Primary end point(s): GFR by modified diabetic renal diet (MDRD) calculation Secondary Objective: To determine any differences between abacavir and tenofovir containing regimens in terms of other renal markers and bone markers INCLUSION CRITERIA: 1. The ability to understand and sign a written informed consent form, prior to participation in any screening procedures and must be willing to comply with all study requirements 2. Participated in screening protocol SSAT 017 (within the last 6 months) 3. Stable on tenofovir [tenofovir 300mg (Viread®) or Tenofovir/lamivudine 300/200mg Truvada®)] for at least 6 months 4. Documented HIV‐1 RNA of less that 50 copies/ml (within the last 3 months) 5. At least 18 years of age 6. Abnormal renal function (MDR GFR 50‐90ml/min/1.73m², serum cystatin C> 1.5 X upper limit of normal range) 7. Negative HLA B5701 test at least two weeks prior to the baseline visit Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18‐64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range