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| Tracking Information | |||||
|---|---|---|---|---|---|
| First Received Date ICMJE | September 7, 2005 | ||||
| Last Updated Date | April 7, 2008 | ||||
| Start Date ICMJE | March 2000 | ||||
| Primary Completion Date | |||||
| Current Primary Outcome Measures ICMJE |
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| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT00158821 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
To evaluate the long-term efficacy, safety and tolerability of tenofovir DF in combination with lamivudine and efavirenz through approximately 336 weeks of drug exposure. | ||||
| Original Secondary Outcome Measures ICMJE | Same as current | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Study of Treatment of Antiretroviral-Naive, HIV-1-Infected Patients Comparing Tenofovir Disoproxil Fumarate Administered in Combination With Lamivudine and Efavirenz vs. Stavudine, Lamivudine and Efavirenz. | ||||
| Official Title ICMJE | A Phase 3, Randomized, Double-Blind, Multicenter Study of the Treatment of Antiretroviral-Naive, HIV-1-Infected Patients Comparing Tenofovir Disoproxil Fumarate Administered in Combination With Lamivudine and Efavirenz vs. Stavudine, Lamivudine and Efavirenz.(Extension) | ||||
| Brief Summary | To compare tenofovir DF plus lamivudine plus efavirenz vs. stavudine plus lamivudine plus efavirenz in the treatment of HIV-1-infected patients who have never taken antiretroviral drugs and have a viral load of less than 400 copies/mL at week 48. |
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| Detailed Description | To compare the two treatment groups with the goal of achieving HIV-1 RNA levels less than 50 copies/mL at week 48. To compare the safety, efficacy and tolerability of the two treatment regimens through 144 weeks of drug exposure. To evaluate the long-term efficacy, safety and tolerability of tenofovir DF in combination with lamivudine and efavirenz through approximately 336 weeks of drug exposure. |
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| Study Phase | Phase III | ||||
| Study Type ICMJE | Interventional | ||||
| Study Design ICMJE | Treatment | ||||
| Condition ICMJE | HIV Infections | ||||
| Intervention ICMJE |
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| Study Arms / Comparison Groups | |||||
| Publications * | Valdez JR, Cassetti I, Suleiman JM, Etzel A, Zhong L, Holmes CB, Cheng AK, Enejosa J; Study 903E Team. The safety and efficacy of switching stavudine to tenofovir df in combination with lamivudine and efavirenz in hiv-1-infected patients: three-year follow-up after switching therapy. HIV Clin Trials. 2007 Nov-Dec;8(6):381-90. | ||||
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Active, not recruiting | ||||
| Enrollment ICMJE | 180 | ||||
| Completion Date | February 2006 | ||||
| Primary Completion Date | |||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 18 Years and older | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | |||||
| Administrative Information | |||||
| NCT ID ICMJE | NCT00158821 | ||||
| Responsible Party | |||||
| Study ID Numbers ICMJE | GS-99-903 | ||||
| Study Sponsor ICMJE | Gilead Sciences | ||||
| Collaborators ICMJE | |||||
| Investigators ICMJE |
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| Information Provided By | Gilead Sciences | ||||
| Verification Date | April 2008 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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