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| Sponsor: | Gilead Sciences |
|---|---|
| Information provided by (Responsible Party): | Gilead Sciences |
| ClinicalTrials.gov Identifier: | NCT00158821 |
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
HIV Infections |
Drug: Viread (tenofovir disoproxil fumarate) Drug: Sustiva (Efavirenz) Drug: Epivir (Lamivudine) Drug: Zerit (Stavudine) |
Phase III |
| Study Type: | Interventional |
| Study Design: | Primary Purpose: Treatment |
| Official Title: | 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) |
| Estimated Enrollment: | 180 |
| Study Start Date: | March 2000 |
| Estimated Study Completion Date: | March 2013 |
| Estimated Primary Completion Date: | February 2013 (Final data collection date for primary outcome measure) |
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations
More Information
| Responsible Party: | Gilead Sciences |
| ClinicalTrials.gov Identifier: | NCT00158821 History of Changes |
| Other Study ID Numbers: | GS-99-903 |
| Study First Received: | September 7, 2005 |
| Last Updated: | September 7, 2011 |
| Health Authority: | United States: Food and Drug Administration |
|
HIV Antiretroviral Treatment Experienced HIV-1 |
|
HIV Infections Acquired Immunodeficiency Syndrome Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Immunologic Deficiency Syndromes Immune System Diseases Slow Virus Diseases Stavudine Lamivudine Tenofovir disoproxil |
Tenofovir Efavirenz Antimetabolites Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Reverse Transcriptase Inhibitors Nucleic Acid Synthesis Inhibitors Enzyme Inhibitors Anti-Retroviral Agents Antiviral Agents Anti-Infective Agents Therapeutic Uses Anti-HIV Agents |