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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00158821 | Study of Treatment of Antiretroviral-naive, HIV-1-Infected Patients Comparing Tenofovir Disoproxil Fumarate Administered in Combination With Lamivudine and Efavirenz vs. Stavudine, Lamivudine and Efavirenz. | PHASE3 | COMPLETED | 180 | — | — | Mar 1, 2000 | Jun 1, 2013 | Jun 25, 2013 | - | — |
compare the two treatment groups with the goal of achieving HIV-1 RNA levels
compare the safety, efficacy and tolerability of the two treatment regimens through 144 weeks of drug exposure
| Name | Type | Description |
|---|---|---|
| Viread (tenofovir disoproxil fumarate) | DRUG | Tenofovir DF 300 mg tablets once daily |
| Sustiva (Efavirenz) | DRUG | efavirenz capsules 600 mg once daily |
| Epivir (Lamivudine) | DRUG | lamivudine 150 mg tablets twice daily |
| Zerit (Stavudine) Placebo | DRUG | stavudine placebo capsules twice daily |
Inclusion Criteria: * Completed the original 96-weeks of open-label treatment. Willingness to use effective contraception by both males and females while on study treatment and for 30 days following study drugs completion. The ability to understand and sign a written informed consent form, which mu...