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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.
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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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Viread (tenofovir disoproxil fumarate) | Drug | Tenofovir DF 300 mg tablets once daily |
| |
| Sustiva (Efavirenz) | Drug | efavirenz capsules 600 mg once daily |
| |
| Epivir (Lamivudine) | Drug | lamivudine 150 mg tablets twice daily |
| |
| Zerit (Stavudine) Placebo | Drug | stavudine placebo capsules twice daily |
|
| Measure | Description | Time Frame |
|---|---|---|
| To compare the two treatment groups with the goal of achieving HIV-1 RNA levels less than 50 copies/mL at week 48. | compare the two treatment groups with the goal of achieving HIV-1 RNA levels | Week 48 |
| To compare the safety, efficacy and tolerability of the two treatment regimens through 144 weeks of drug exposure. | compare the safety, efficacy and tolerability of the two treatment regimens through 144 weeks of drug exposure | 144 Weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | evaluate the long-term efficacy, safety and tolerability of tenofovir DF in combination with lamivudine and efavirenz through approximately 336 weeks of drug exposure | 336 Weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Erin Quirk, M.D. | Gilead Sciences | Study Director |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 18042503 | Derived | Madruga 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. doi: 10.1310/hct0806-381. |
| Label | URL |
|---|---|
| Gilead website | View source |
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| To evaluate the long term efficacy, safety and tolerability of tenofovir DF in combination with lamivudine and efavirenz through approximately 480 weeks of drug exposure. | evaluate the long term efficacy, safety and tolerability of tenofovir DF in combination with lamivudine and efavirenz through approximately 480 weeks of drug exposure. | 480 Weeks |
| To evaluate the long term efficacy, safety and tolerability of tenofovir DF through approximately 624 weeks of drug exposure. | evaluate the long term efficacy, safety and tolerability of tenofovir DF through approximately 624 weeks of drug exposure | 624 Weeks |
| Study Results | View source |
| ID | Term |
|---|---|
| D015658 | HIV Infections |
| ID | Term |
|---|---|
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D015229 | Sexually Transmitted Diseases, Viral |
| D012749 | Sexually Transmitted Diseases |
| D016180 | Lentivirus Infections |
| D012192 | Retroviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D007153 | Immunologic Deficiency Syndromes |
| D007154 | Immune System Diseases |
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| ID | Term |
|---|---|
| D000068698 | Tenofovir |
| C098320 | efavirenz |
| D019259 | Lamivudine |
| D018119 | Stavudine |
| ID | Term |
|---|---|
| D063065 | Organophosphonates |
| D009943 | Organophosphorus Compounds |
| D009930 | Organic Chemicals |
| D000225 | Adenine |
| D011687 | Purines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D016047 | Zalcitabine |
| D003841 | Deoxycytidine |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D003853 | Deoxyribonucleosides |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
| D015224 | Dideoxynucleosides |
| D013936 | Thymidine |
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