Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 2:22 AM
Ignite Modification Date:
2025-12-25 @ 2:22 AM
NCT ID:
NCT00192634
Eligibility Criteria:
Inclusion Criteria:
* documented HIV infection
* age at least 18 years
* stable (≥ 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 baseline
* HIV RNA \< 50 copies/mL plasma for the preceding 12 weeks
* GFR ≥ 70 mL/min/1.73m2 (estimated by the abbreviated MDRD equation23 estimated GFR = 186 x (\[SCR/88.4\]-1.154) x age-0.203 x (0.742 if female) x (1.210 if African-American)
* provision of written, informed consent
Exclusion Criteria:
* HLA-B\*5701 positive at screening OR evidence of previous ABC hypersensitivity OR clinical failure in participants taking abacavir for at least 30 days
* current therapy comprising triple NRTI therapy alone
* current use of ABC/3TC FDC (Kivexa) or TDF/FTC FDC (Truvada)
* history of non-traumatic osteoporotic fracture
* prior hypersensitivity or intolerance to ABC, 3TC, TDF or FTC
* prior clinical failure to a regimen containing ABC or TDF
* prior use of TDF for control of previously active hepatitis B (HBsAg+ or HBV DNA+) in patients likely to be resistant to 3TC/FTC
* current therapy including unboosted atazanavir
* concurrent use of aminoglycosides, IV amphotericin B, cidofovir, cisplatin, foscarnet, IV pentamidine, probenecid, adefovir or immunomodulatory agents
* clinical evidence of cirrhosis (e.g. smooth liver, no features of portal hypertension)
* creatinine clearance \< 50 mL/min (estimated by the Cockcroft-Gault equation)18,19
* Male: (140 - age in years) x (wt in kg) = CLCr (mL/min) 0.814 x (serum creatinine in µmol/L)
* Female:(140 - age in years) x (wt in kg) x 0.85 = CLCr (mL/min) 0.814 x (serum creatinine in µmol/L)
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00192634
Study Brief:
Protocol Section:
NCT00192634