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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00043966 | Study of Lopinavir, Ritonavir, Tenofovir and Emtricitabine in HIV-Infected Antiretroviral Naïve Subjects | PHASE3 | COMPLETED | 200 | — | — | Jul 1, 2002 | - | Jul 27, 2006 | 52 | United States, Australia +5 |
| NCT00038636 | A Study of Two Different Doses of ABT-378/Ritonavir in HIV-Infected Patients Who Have Taken Protease Inhibitors and Non-Nucleoside Reverse Transcriptase Inhibitors | PHASE3 | COMPLETED | 36 | — | — | Sep 1, 2000 | - | Aug 15, 2006 | 7 | United States, France +1 |
| NCT00004583 | A Phase III Study Comparing Two Different Anti-HIV Drug Combinations in HIV-Positive Patients Without Previous Anti-HIV Drug Therapy | PHASE3 | COMPLETED | 660 | — | — | Mar 1, 1999 | - | Feb 20, 2009 | 83 | United States, Australia +12 |
| NCT00004581 | A Study to Compare Two Anti-HIV Drug Combinations in HIV-Infected Patients Who Have Previously Received Anti-HIV Treatment | PHASE3 | COMPLETED | 300 | — | — | - | - | Feb 20, 2009 | 88 | United States, Australia +12 |
| NCT00043953 | Lopinavir/Ritonavir in Combination With Saquinavir Mesylate or Lamivudine/Zidovudine to Explore Metabolic Toxicities in Antiretroviral HIV-Infected Subjects | PHASE2 | COMPLETED | 30 | — | — | Aug 1, 2002 | - | Sep 27, 2007 | 11 | United States, Canada |
| NCT00038220 | Effectiveness of ABT-378/Ritonavir Plus Lamivudine Plus Efavirenz Plus Tenofovir DF in HIV-Infected Patients | PHASE2 | COMPLETED | 40 | — | — | Jul 1, 2000 | - | Jul 27, 2006 | 1 | United States |
| NCT00004578 | ABT-378/Ritonavir in Combination With Reverse Transcriptase Inhibitors in Antiretroviral Naïve HIV-Infected Subjects | PHASE1 | COMPLETED | 100 | — | — | Nov 1, 1997 | Apr 1, 2005 | Apr 3, 2008 | 10 | United States |
| NCT00004580 | A Study of ABT-378/Ritonavir Combination in HIV-Infected Patients Who Have Taken Protease Inhibitors | PHASE1 | COMPLETED | - | — | — | - | - | Feb 20, 2009 | 10 | United States |
| Arm | Type | Description |
|---|---|---|
| 1 | ACTIVE_COMPARATOR | Group 1, n=32 initiated with ABT-378 \& ritonavir; after 3 wks stavudine and lamivudine was added. |
| 2 | ACTIVE_COMPARATOR | Group II patients (n=68) to be randomized after all Group I patients are enrolled and safety analysis is completed. |
| Name | Type | Description |
|---|---|---|
| Lopinavir/ritonavir | DRUG | - |
| Tenofovir DF | DRUG | - |
| Emtricitabine | DRUG | - |
| Ritonavir | DRUG | - |
| Nelfinavir mesylate | DRUG | - |
| Lamivudine | DRUG | - |
| Stavudine | DRUG | - |
| Nevirapine | DRUG | - |
| Saquinavir mesylate | DRUG | - |
| Lamivudine/zidovudine | DRUG | - |
| Efavirenz | DRUG | - |
Inclusion Criteria: * Subject is at least 18 years of age. * If female, subject is not of childbearing potential, defined as postmenopausal for at least 1 year or surgically sterile (bilateral tubal ligation, bilateral oophorectomy or hysterectomy), or is of childbearing potential and practicing on...