The STEAL Study

Phase 3

• Conditions: HIV; Infection - Acquired immune deficiency syndrome (AIDS / HIV)

• Registration Number: ACTRN12605000505606
• Lead Sponsor: The National Centre in HIV Epidemiology and Clinical Research

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2005-09-26
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: All
• Target Recruitment: 350

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).

Study & Design

• Study Type: Interventional
• Study Design: Not specified