HIV
Conditions
Interventions
Trade Name: Ziagen
Product Name: Ziagen
Product Code: Not appllicable
Pharmaceutical Form: Film-coated tablet
Other descriptive name: Ab
Sponsors
St Stephens AIDS Trust
Eligibility
Sex/Gender
All
Inclusion criteria
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
Exclusion criteria
Exclusion criteria: 1. Patients currently taking or who have taken any nephrotoxic drugs within th elast 3 months: e.g. Adefovir, cidofovir, aminoglycosides, metronidazole, amphoteracin, foscarnet, IV pentamadine 2. Requirement to commence any new renal toxic drugs 3. Pregnant or lactating women
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To determine any differences in renal function in patients who continue treatment with tenofovir versus those whose tenofovir is replaced with abacavir;Secondary Objective: To determine any differences between abacavir and tenofovir containing regimens in terms of other renal markers and bone markers;Primary end point(s): GFR by modified diabetic renal diet (MDRD) calculation | — |
Countries
United Kingdom
Outcome results
None listed