|
Home
Search
Study Topics
Glossary
|
![]() |
![]() |
|
![]() |
|
![]() |
|
![]() |
![]() |
![]() |
|
![]() |
![]() |
||||||||||||||||||||||||||||||||||||
| Sponsor: | Gilead Sciences |
|---|---|
| Information provided by: | Gilead Sciences |
| ClinicalTrials.gov Identifier: | NCT00106379 |
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
HIV Infections |
Drug: Truvada (tenofovir DF + emtricitabine) Drug: Emtriva (emtricitabine) Drug: Viread (tenofovir DF) |
Phase IV |
| Study Type: | Interventional |
| Study Design: | Treatment, Non-Randomized, Open Label, Active Control, Single Group Assignment, Safety/Efficacy Study |
| 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 |
| Estimated Enrollment: | 52 |
| Study Start Date: | October 2004 |
| Study Completion Date: | January 2007 |
The primary objective of this study is as follows:
The secondary objectives of this study are as follows:
Eligibility| Ages Eligible for Study: | 18 Years to 80 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Patients must meet all of the following inclusion criteria to be eligible for participation in the study.
Exclusion Criteria:
Patients who meet any of the following are not to be enrolled in this study.
Contacts and Locations| United States, Florida | |
| Treasure Coast Infectious Disease Consultants | |
| Vero Beach, Florida, United States, 32960 | |
| Gary Richmond, MD | |
| Fort Lauderdale, Florida, United States, 33316 | |
| United States, Maryland | |
| Ronald Reisler, MD | |
| Baltimore, Maryland, United States, 21201 | |
| United States, Texas | |
| Fernando Garcia, MD | |
| Harlingen, Texas, United States, 78550 | |
More Information
| Study ID Numbers: | GS-104-0235 |
| Study First Received: | March 23, 2005 |
| Last Updated: | February 1, 2010 |
| ClinicalTrials.gov Identifier: | NCT00106379 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
|
HIV-1 Treatment Naive Treatment Experienced |
|
Anti-Infective Agents Sexually Transmitted Diseases, Viral Slow Virus Diseases Molecular Mechanisms of Pharmacological Action Infection Reverse Transcriptase Inhibitors Emtricitabine Anti-Retroviral Agents Therapeutic Uses Tenofovir Retroviridae Infections Nucleic Acid Synthesis Inhibitors Tenofovir disoproxil |
RNA Virus Infections Anti-HIV Agents Immune System Diseases Acquired Immunodeficiency Syndrome Enzyme Inhibitors Antiviral Agents Immunologic Deficiency Syndromes Pharmacologic Actions Virus Diseases HIV Infections Sexually Transmitted Diseases Lentivirus Infections |