Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00675844 | An Open-Label Treatment Protocol to Provide Continued Elvucitabine Treatment | PHASE2 | COMPLETED | 7 | — | — | May 1, 2008 | Mar 1, 2010 | Aug 14, 2023 | 5 | United States |
| NCT00350272 | Elvucitabine/Efavirenz/Tenofovir Versus Lamivudine/Efavirenz/Tenofovir in Human Immunodeficiency Virus (HIV)-1 Infected, Treatment-naive Participants | PHASE2 | COMPLETED | 76 | — | — | May 1, 2006 | Apr 1, 2009 | Aug 30, 2023 | 26 | United States, Puerto Rico |
| NCT00312039 | Study of Once Daily Elvucitabine Versus Lamivudine in Participants With a Documented M184V Mutation | PHASE1 | COMPLETED | 20 | — | — | Mar 31, 2006 | Oct 31, 2007 | Aug 25, 2023 | 8 | United States |
The proportion of participants having achieved a virologic response for elvucitabine 10 mg/day in combination with efavirenz and tenofovir in HIV-1-infected participants over 12 weeks compared with the proportion of participants having achieved a virologic response for lamivudine 300 mg/day in combination with efavirenz and tenofovir. Virologic response was defined as having achieved undetectable (\<50 copies/mL) HIV-1 RNA levels from baseline assessment.
Determination of the safety profile of elvucitabine as defined by the frequency, type and severity of treatment-emergent adverse events (AEs) and the frequency of Grade 3 and Grade 4 laboratory abnormalities.
| Arm | Type | Description |
|---|---|---|
| Elvucitabine | EXPERIMENTAL | Participants currently receiving elvucitabine will continue elvucitabine as part of their antiretroviral therapy (ART) regimen for an additional 48 months. |
| Elvucitabine, Efavirenz, Tenofovir | EXPERIMENTAL | Elvucitabine (blinded) 10 milligrams (mg)/day in combination with open-label efavirenz 600 mg daily and open-label tenofovir 300 mg daily, all administered orally, over 12 weeks. Eligible participants continued with an additional 84 weeks of open-label treatment (through Week 96). Participants who experienced at least a 2 log10 decrease in HIV-1 RNA from Baseline or who had an HIV-1 RNA level of less than 400 copies/ mL at Week 10 and had not experienced any Grade 3 or 4 hematological toxicity as of the Week 10 measurement were considered eligible for an additional 84 weeks of open-label treatment after Week 12. |
| Lamivudine, Efavirenz, Tenofovir | ACTIVE_COMPARATOR | Lamivudine (blinded) 300 mg daily in combination with open-label efavirenz 600 mg daily and open-label tenofovir 300 mg daily, all administered orally, over 12 weeks. Eligible participants continued with an additional 84 weeks of open-label treatment (through Week 96). Participants who experienced at least a 2 log10 decrease in HIV-1 RNA from Baseline or who had an HIV-1 RNA level of less than 400 copies/mL at Week 10 and had not experienced any Grade 3 or 4 hematological toxicity as of the Week 10 measurement were considered eligible for an additional 84 weeks of open-label treatment after Week 12. |
| A | EXPERIMENTAL | - |
| B | ACTIVE_COMPARATOR | - |
| Name | Type | Description |
|---|---|---|
| Elvucitabine | DRUG | 10 milligrams (mg) elvucitabine daily as part of an ART regimen |
| Lamivudine | DRUG | Lamivudine 300 mg orally daily |
| Tenofovir | DRUG | Tenofovir open-label 300 mg orally daily |
| Efavirenz | DRUG | Efavirenze open-label 600 mg orally daily |
Inclusion Criteria: • Participants must have successfully completed 96 weeks of elvucitabine therapy in Protocol ACH443-015 or participants have completed 48 weeks of elvucitabine therapy in Protocol ACH443-014A-018 . Exclusion Criteria: * Participant has experienced virologic rebound as defined ...