Tenofovir DF (Disoproxil Fumarate) in Combination With Emtricitabine in HIV-1 Patients
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00106379|
Recruitment Status : Completed
First Posted : March 24, 2005
Last Update Posted : February 2, 2010
|Condition or disease||Intervention/treatment||Phase|
|HIV Infections||Drug: Truvada (tenofovir DF + emtricitabine) Drug: Emtriva (emtricitabine) Drug: Viread (tenofovir DF)||Phase 4|
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 (Clinical Trial)|
|Enrollment :||52 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
|Study Start Date :||October 2004|
|Actual Study Completion Date :||January 2007|
- HIV-1 infection
- HIV-1 infection in renally impaired HIV infected patients
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00106379
|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|