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| Sponsor: | Gilead Sciences |
|---|---|
| Information provided by: | 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: | 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: | February 2006 |
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
| Study ID Numbers: | GS-99-903 |
| Study First Received: | September 7, 2005 |
| Last Updated: | April 7, 2008 |
| ClinicalTrials.gov Identifier: | NCT00158821 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
|
HIV Antiretroviral Treatment Experienced HIV-1 |
|
Antimetabolites Anti-Infective Agents Sexually Transmitted Diseases, Viral Stavudine Slow Virus Diseases Molecular Mechanisms of Pharmacological Action Lamivudine Infection Reverse Transcriptase Inhibitors 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 |