None listed
Conditions
Brief summary
Combination antiretroviral therapy for the treatment of HIV has a high pill burden. Two dual-tablets, abacavir-lamivudine and tenofovir-emtricitabine, are now licensed in the United States and will be available in Australia in December 2005. Data available suggest that the potency of these tablets are similar in controlling replication of the HIV virus, but not have not been directly compared in regard to clinically significant toxicities. We therefore aim to compare the overall safety and efficacy of the two dual-tablets over a 2 year period in HIV infected adults. We hypothesise that the two dual-NRTI treatments will be similar in efficacy and safety.
Interventions
Combination antiretroviral therapy for the treatment of HIV has a high pill burden. Two dual-tablets, abacavir-lamivudine and tenofovir-emtricitabine, are now licensed in the United States and will be available in Australia in December 2005. Data available suggest that the potency of these tablets are similar in controlling replication of the HIV virus, but not have not been directly compared in regard to clinically significant toxicities. We therefore aim to compare the overall safety and ef
Combination antiretroviral therapy for the treatment of HIV has a high pill burden. Two dual-tablets, abacavir-lamivudine and tenofovir-emtricitabine, are now licensed in the United States and will be available in Australia in December 2005. Data available suggest that the potency of these tablets are similar in controlling replication of the HIV virus, but not have not been directly compared in regard to clinically significant toxicities. We therefore aim to compare the overall safety and efficacy of the two dual-tablets over a 2 year period in HIV infected adults. We hypothesise that the two dual-NRTI treatments will be similar in efficacy and safety.
Sponsors
The National Centre in HIV Epidemiology and Clinical Research
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. documented HIV infection2. age at least 18 years3. stable (greater than or equal to 12 weeks) ART including at least two NRTIs, currently well tolerated, with no plan to change any other component of the ART regimen at or after baseline4. HIV RNA < 50 copies/mL plasma for the preceding 12 weeks5. GFR greater than or equal to 70 mL/min/1.73m2 (estimated by the abbreviated MDRD equation23estimated GFR = 186 x ([SCR/88.4]-1.154) x age-0.203 x (0.742 if female) x (1.210 if African-American)6. provision of written, informed consent.
Exclusion criteria
1. HLA-B57*01 positive at or prior to screening OR evidence of previous hypersensitivity or clinical failure with abacavir2. current therapy comprising triple NRTI therapy alone3. current use of ABC/3TC FDC (Kivexa) or TDF/FTC FDC (Truvada)4. pregnancy or breast feeding5. history of osteoporotic fracture6. prior hypersensitivity or intolerance to ABC, 3TC, TDF or FTC7. prior clinical failure to a regimen containing ABC or TDF8. prior use of TDF for control of previously active hepatitis B (HBsAg+ or HBV DNA+) in patients likely to be resistant to 3TC/FTC9. current therapy including unboosted atazanavir10. concurrent use of aminoglycosides, IV amphotericin B, cidofovir, cisplatin, foscarnet, IV pentamidine, probenecid, adefovir or immunomodulatory agents11. clinical evidence of cirrhosis (e.g. smooth liver, no features of portal hypertension)12. creatinine clearance < 50 mL/min (estimated by the Cockcroft-Gault equation)Male: (140 - age in years) x (wt in kg) = CLCr (mL/min) 0.814 x (serum creatinine in ÿµmol/L)Female:(140 - age in years) x (wt in kg) x 0.85 = CLCr (mL/min) 0.814 x (serum creatinine in ÿµmol/L).
Outcome results
None listed