Tenofovir DF (Disoproxil Fumarate) in Combination With Emtricitabine in HIV-1 Patients
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.
Drug: Truvada (tenofovir DF + emtricitabine)
Drug: Emtriva (emtricitabine)
Drug: Viread (tenofovir DF)
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase 4, Single-Arm Study to Evaluate the Safety, Antiviral Activity and Pharmacokinetics of Tenofovir Disoproxil Fumarate in Combination With Emtricitabine in HIV-1 Infected Patients Experiencing Various Degrees of Renal Impairment|
- HIV-1 infection
- HIV-1 infection in renally impaired HIV infected patients
|Study Start Date:||October 2004|
|Study Completion Date:||January 2007|
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.
|United States, Florida|
|Gary Richmond, MD|
|Fort Lauderdale, Florida, United States, 33316|
|Treasure Coast Infectious Disease Consultants|
|Vero Beach, Florida, United States, 32960|
|United States, Maryland|
|Ronald Reisler, MD|
|Baltimore, Maryland, United States, 21201|
|United States, Texas|
|Fernando Garcia, MD|
|Harlingen, Texas, United States, 78550|