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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00270296 | Trizivir Vs. Kaletra and Combivir for the Prevention of Mother-to-Child Transmission of HIV | PHASE2 | COMPLETED | 730 | — | — | Jun 1, 2006 | Sep 1, 2010 | Nov 2, 2021 | 4 | Botswana |
Suppression of the plasma HIV-1 RNA level to less than 400 copies per milliliter
Number of infants with HIV-positive status
| Arm | Type | Description |
|---|---|---|
| Trizivir (TZV) Arm | EXPERIMENTAL | Participants in the TZV Arm (Arm 1A) will be pregnant women who have CD4 counts of 200 cells/mm3 or more. As the intervention, they will receive TZV twice daily. Once in labor, these participants will continue to take TZV twice daily and will also be given additional ZDV. |
| Kaletra Arm | EXPERIMENTAL | Participants in the Kaletra Arm (Arm 1B) will be pregnant women who have CD4 counts of 200 cells/mm3 or more. As the intervention, they will receive Lamivudine/Zidovudine (3TC/ZDV) and Lopinavir/Ritonavir (LPV/RTV) twice daily. Once in labor, these participants will continue to take TZV twice daily and will also be given additional ZDV. |
| Nevirapine (NVP) Arm | EXPERIMENTAL | Participants in the NVP Arm (Arm 2) will be pregnant women who have have CD4 counts less than 200 cells/mm3. These participants will receive NVP once daily for the first 14 days, then twice daily, and 3TC/ZDV twice daily; these women will be in the observational group. |
| Name | Type | Description |
|---|---|---|
| Trizivir | DRUG | 300 mg abacavir sulfate/150 mg lamivudine/300 mg zidovudine tablet taken orally twice daily |
| Lamivudine/Zidovudine | DRUG | 150 mg lamivudine/300 mg zidovudine tablet taken orally twice daily |
| Lopinavir/Ritonavir | DRUG | 400 mg lopinavir/100 mg ritonavir tablet taken orally twice daily |
| Nevirapine | DRUG | 200 mg tablet taken orally daily for the first 14 days before receiving 200 mg tablet taken orally twice daily |
Inclusion Criteria for Mothers: * HIV-infected * At least at 26th week of pregnancy (treatment group) or 18th week of pregnancy (observational group) but not beyond the 34th week of pregnancy * Able to complete study visits until at least 6 months postpartum * Citizen of Botswana Exclusion Criteri...