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| Sponsor: | Gilead Sciences |
|---|---|
| Information provided by: | Gilead Sciences |
| ClinicalTrials.gov Identifier: | NCT00112047 |
Purpose
The purpose of this study is to assess two regimens in antiretroviral-naive subjects.
| Condition | Intervention | Phase |
|---|---|---|
|
HIV Infections |
Drug: Viread (tenofovir disoproxil fumarate ) Drug: Emtriva (emtricitabine) Drug: Combivir (zidovudine + lamivudine) Drug: Sustiva (efavirenz) |
Phase III |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study |
| Official Title: | Phase 3/Randomized/Open-Label Study of the Treatment of Antiretroviral-Naive HIV-1-Infected Subjects Comparing Tenofovir Disoproxil Fumarate and Emtricitabine in Combination With Efavirenz vs. Combivir (Lamivudine/Zidovudine) and Efavirenz |
| Estimated Enrollment: | 500 |
| Study Start Date: | August 2003 |
| Estimated Study Completion Date: | August 2009 |
The purpose of this study is to assess two regimens in antiretroviral-naive subjects.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria: Subjects must meet all inclusion criteria within 28 days prior to randomization unless specified otherwise:
Exclusion Criteria: Subjects are not eligible for study if any of the following are met:
Contacts and Locations| United States, California | |
| AIDS Healthcare Foundation Research | |
| Beverly Hills, California, United States, 90211 | |
| United States, District of Columbia | |
| Capital Medical Associates, P.C. | |
| Washington, District of Columbia, United States, 20036 | |
| United States, Florida | |
| Orlando Immunology Center | |
| Orlando, Florida, United States, 32804 | |
| United States, Illinois | |
| NorthStar Medical Center | |
| Chicago, Illinois, United States, 60657 | |
| United States, North Carolina | |
| Jemsek Clinic | |
| Huntersville, North Carolina, United States, 28078 | |
| Study Director: | Andrew Cheng, MD, PhD | Gilead Sciences |
More Information
| Study ID Numbers: | GS-01-934 |
| Study First Received: | May 27, 2005 |
| Last Updated: | March 3, 2009 |
| ClinicalTrials.gov Identifier: | NCT00112047 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
|
Human Immunodeficiency Virus |
|
Antimetabolites Anti-Infective Agents Sexually Transmitted Diseases, Viral Slow Virus Diseases Molecular Mechanisms of Pharmacological Action Zidovudine Lamivudine Infection Reverse Transcriptase Inhibitors Emtricitabine Anti-Retroviral Agents Therapeutic Uses Tenofovir Retroviridae Infections Nucleic Acid Synthesis Inhibitors |
Tenofovir disoproxil Efavirenz 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 |