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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00196612 | Once Daily Antiretroviral Therapy in HIV Infected Adults Treated With HAART | PHASE3 | COMPLETED | 350 | — | — | Apr 1, 2001 | Sep 1, 2004 | Sep 20, 2005 | - | — |
| NCT00112047 | Tenofovir Disoproxil Fumarate/Emtricitabine/Efavirenz Versus Combivir/Efavirenz in Antiretroviral-Naive HIV-1 Infected Subjects | PHASE3 | COMPLETED | 517 | — | — | Jul 1, 2003 | Jun 1, 2009 | Oct 13, 2010 | 5 | United States |
| NCT00196599 | Pilot Study on Once Daily FTC, ddI, Efavirenz Combination in Antiretroviral Naive HIV Infected Adults | PHASE2 | COMPLETED | 39 | — | — | Feb 1, 1999 | Sep 1, 2004 | Sep 20, 2005 | - | — |
| NCT00642291 | An Open-Label Study of Emtricitabine in Combination With Other Antiretroviral Agents in HIV Infected Pediatric Subjects | PHASE2 | COMPLETED | 16 | — | — | Nov 1, 2002 | Jul 1, 2004 | Apr 10, 2008 | 2 | Romania |
Participants who achieved/maintained confirmed HIV-1 RNA \< 400 c/mL had to satisfy the following criteria: 1) not experienced death, permanent study drug discontinuation, or addition of new antiretroviral drug except nevirapine in place of EFV prior to Week 48 visit; 2) achieved confirmed HIV-1 RNA \< 400 c/mL on 2 consecutive visits prior to Week 48 visit (ie, the first of the 2 consecutive HIV-1 RNA \< 400 c/mL occurred prior to the Week 48 visit; 3) not had confirmed HIV-1 RNA \> 400 c/mL after achievement of confirmed HIV RNA levels \< 400 c/mL prior to Week 48 visit.
| Arm | Type | Description |
|---|---|---|
| EFV+CBV | ACTIVE_COMPARATOR | Participants in this group received EFV 600 mg once daily + Combivir (\[CBV\]; the fixed dose combination pill containing lamivudine 150 mg + zidovudine 300 mg) taken twice daily from the start of the study until Week 144. At Week 144 all participants who opted to roll over into the additional 96-week study extension received Atripla (\[ATR\]; the fixed-dose combination tablet containing FTC 200 mg/TDF 300 mg/EFV 600 mg) taken once daily until the end of the study (Week 240). At sites in France, the study was extended by a further 48 weeks (Year 6) or until ATR became commercially available (whichever happened first); once ATR became commercially available in France participants were not required to complete the full 288 weeks of the study. |
| EFV+FTC+TDF | EXPERIMENTAL | Participants in this arm received 3 component drugs: efaviren (EFV; 600 mg) + emtricitabine (FTC; 200 mg) + tenofovir disoproxil fumarate (tenofovir DF \[TDF\]; 300 mg) as 3 separate pills once daily from the start of the study. At 96 weeks Truvada (\[TVD\] the fixed-dose combination pill containing FTC/TDF \[200/300 mg\] once daily) replaced the 2 component drugs FTC + TDF; participants continued to receive EFV 600 mg once daily. At Week 144 all participants who opted to roll over into the further 96-week study extension received ATR. At sites in France, the study was extended by a further 48 weeks (Year 6) or until ATR became commercially available (whichever happened first); once ATR became commercially available in France participants were not required to complete the full 288 weeks of the study. |
| 1 | EXPERIMENTAL | Treatment naive pediatric patients (Group 1: ages 3 to 24 months)were to receive emtricitabine (6mg/kg QD; max 200 mg QD) plus stavudine 1 mg/kg BID (if \<30kg)plus lopinavir/ritonavir (12/3 mg/kg BID if \>=7 to \<15kg; 10/2.5 mg/kg BID if \>=15 to \<=40 kg) |
| 2 | EXPERIMENTAL | Treatment naive or experienced pediatric patients (Group 2: ages 7 to 12 years; Group 3: ages 13-17 years) received emtricitabine (6 mg/kg QD, up to 200 mg QD capsule formulation or up to 240 mg QD using the oral solution) plus didanosine (240 mg/m2 up to 400 mg QD) plus efavirenz (up to 600 mg QD capsule formulation or up to 720 mg QD using the oral solution). |
| Name | Type | Description |
|---|---|---|
| emtricitabine, FTC (drug) | DRUG | - |
| didanosine, ddI (drug) | DRUG | - |
| efavirenz (drug) | DRUG | - |
| Emtricitabine (FTC) | DRUG | Capsule containing 200 mg FTC, taken once daily, for 96 weeks |
| Tenofovir Disoproxil Fumarate (TDF) | DRUG | Tablet containing 300 mg TDF, taken once daily, for 96 weeks |
| Efavirenz (EFV) | DRUG | Tablet containing 600 mg EFV, taken once daily, for 96 weeks |
| FTC/TDF | DRUG | Fixed-dose combination tablet containing FTC 200 mg/TDF 300 mg, once daily, from Week 96 to 144 |
| FTC/TDF/EFV | DRUG | Fixed-dose combination tablet containing FTC 200 mg/TDF 300 mg/EFV 600 mg, taken once daily, from Week 144 to 240 |
| Lamivudine/zidovudine | DRUG | Fixed-dose combination tablet containing lamivudine 150 mg/zidovudine 300 mg, taken twice daily, for 240 weeks |
| Emtricitabine | DRUG | emtricitabine (6mg/kg QD; max 200 mg QD) plus stavudine 1 mg/kg BID (if \<30kg)plus lopinavir/ritonavir (12/3 mg/kg BID if \>=7 to \<15kg; 10/2.5 mg/kg BID if \>=15 to \<=40 kg) |
Inclusion Criteria: * HIV infected adults * Antiretroviral treatment since 6 months, with two nucleoside analogues and one or two protease inhibitors * CD4 cell count over 100/mm3 * HIV RNA below 400 copies/ml since 6 months * Signed written informed consent Exclusion Criteria: * Previous treatme...