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The purpose of this study is to evaluate whether a therapy with an all once daily regimen of efavirenz (EFV), didanosine (ddI)-EC and lamivudine (3TC) 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; didanosine EC; lamivudine | Drug |
| Measure | Description | Time Frame |
|---|---|---|
| Estimate efficacy of ddI-EC/3TC/EFV given QD determined by proportion of patients with plasma HIV-1 RNA <400 copies/mL at 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 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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| Name | Affiliation | Role |
|---|---|---|
| Bristol-Myers Squibb | Bristol-Myers Squibb | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Local Institution | Washington D.C. | District of Columbia | United States | |||
| Local Institution |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20133268 | Derived | 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 from change in baseline at week 48 |
| Determine proportion of patients whose HIV viral load doesn't drop to undetectable level within 24 weeks |
| 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 patients experiencing virologic failure |
| Explore QoL changes using MOS-HIV health survey |
| Evaluate safety and tolerability of QD regimen |
| Orlando |
| Florida |
| United States |
| Local Institution | Columbus | Georgia | United States |
| Local Institution | Boston | Massachusetts | United States |
| Local Institution | Springfield | Massachusetts | United States |
| Local Institution | Kansas City | Missouri | United States |
| Local Institution | Hillsborough | New Jersey | United States |
| Local Institution | The Bronx | New York | 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 |
| D016049 | Didanosine |
| D019259 | Lamivudine |
| ID | Term |
|---|---|
| D007288 | Inosine |
| D011684 | Purine Nucleosides |
| D011687 | Purines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D015224 | Dideoxynucleosides |
| D003853 | Deoxyribonucleosides |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
| D012263 | Ribonucleosides |
| D016047 | Zalcitabine |
| D003841 | Deoxycytidine |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
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