The purpose of this study is to provide long-term clinical safety and efficacy data for tenofovir disoproxil fumarate and emtricitabine in HIV-infected patients experiencing various degrees of renal impairment.
The primary objective of this study is as follows: * To evaluate the safety and tolerability of tenofovir following administration of tenofovir disoproxil fumarate 300 mg for 48 weeks in HIV-infected patients experiencing various degrees of renal impairment. The secondary objectives of this study are as follows: * To evaluate the safety and tolerability of emtricitabine following administration of emtricitabine 200 mg for 48 weeks in HIV-infected patients experiencing various degrees of renal impairment. * To evaluate the efficacy of tenofovir disoproxil fumarate in combination with emtricitabine in renally-impaired HIV-infected patients. * To evaluate the pharmacokinetics of tenofovir and emtricitabine in renally-impaired HIV-infected patients.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
52
Gary Richmond, MD
Fort Lauderdale, Florida, United States
Treasure Coast Infectious Disease Consultants
Vero Beach, Florida, United States
Ronald Reisler, MD
Baltimore, Maryland, United States
Fernando Garcia, MD
Harlingen, Texas, United States
HIV-1 infection
HIV-1 infection in renally impaired HIV infected patients
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