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The purpose of this study is to evaluate whether a therapy with an all once daily regimen of stavudine extended release (d4T XR), lamivudine (3TC), and efavirenz (EFV) leads to improved outcomes, as measured by viral load, CD4 counts, adherence, safety, and tolerability.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| efavirenz, stavudine extended release, lamivudine | Drug |
| Measure | Description | Time Frame |
|---|---|---|
| Estimate efficacy of d4T-XR/3TC/EFV given QD determined by | ||
| proportion of patients with plasma HIV RNA < 400 copies/mL after 48 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Evaluate proportion of patients with plasma HIV RNA < 400 copies/mL at Weeks 24, 48, 72, and 96 | ||
| Evaluate the proportion of patients with plasma HIV RNA < 50 copies/mL at Weeks 24, 48, 72, and 96 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Local Institution | Bakersfield | California | United States | |||
| Local Institution |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20133268 | Background | Jayaweera D, Dejesus E, Nguyen KL, Grimm K, Butcher D, Seekins DW. Virologic suppression, treatment adherence, and improved quality of life on a once-daily efavirenz-based regimen in treatment-Naive HIV-1-infected patients over 96 weeks. HIV Clin Trials. 2009 Nov-Dec;10(6):375-84. doi: 10.1310/hct1006-375. | |
| 20133267 | Derived |
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| Determine viral suppression of plasma HIV RNA change in baseline at week 48 |
| Determine proportion of patients whose HIV viral load doesn't drop to undetectable level within 24 weeks of therapy initiation |
| Evaluate time to undetectable plasma HIV RNA |
| Evaluate proportion of patients demonstrating virologic breakthrough |
| Evaluate proportion of patients demonstrating virologic failure |
| Evaluate time to virologic breakthrough and virologic failure |
| Measure magnitude and durability of changes in CD4 cell counts |
| Evaluate patient adherence with QD regimen using pill counts and AMAF |
| Determine pattern and emergence of HIV genotype resistance mutations in subjects experiencing virologic failure |
| Explore QoL changes using MOS-HIV health survey |
| Evaluate safety and tolerability of QD regimen |
| San Francisco |
| California |
| United States |
| Local Institution | Washington D.C. | District of Columbia | United States |
| Local Institution | Fort Lauderdale | Florida | United States |
| Local Institution | Jacksonville | Florida | United States |
| Local Institution | Miami | Florida | United States |
| Local Institution | New York | New York | United States |
| Local Institution | Greenville | North Carolina | United States |
| Local Institution | Oklahoma City | Oklahoma | United States |
| Local Institution | Dallas | Texas | United States |
| Nunes EP, Santini de Oliveira M, Mercon M, Zajdenverg R, Faulhaber JC, Pilotto JH, Ribeiro JE, Norton M, Schechter M. Monotherapy with Lopinavir/Ritonavir as maintenance after HIV-1 viral suppression: results of a 96-week randomized, controlled, open-label, pilot trial (KalMo study). HIV Clin Trials. 2009 Nov-Dec;10(6):368-74. doi: 10.1310/hct1006-368. |
| ID | Term |
|---|---|
| D015658 | HIV Infections |
| D000163 | Acquired Immunodeficiency Syndrome |
| 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 |
| D012897 | Slow Virus Diseases |
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| ID | Term |
|---|---|
| C098320 | efavirenz |
| D019259 | Lamivudine |
| ID | Term |
|---|---|
| D016047 | Zalcitabine |
| D003841 | Deoxycytidine |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D003853 | Deoxyribonucleosides |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
| D015224 | Dideoxynucleosides |
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