Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: Maternal Tenofovir-containing Combination Drug Regimen During the Second and Third Trimesters of Pregnancy for Prevention of Mother-to-child Transmission of HIV and HBV in HIV-HBV Co-infected Mothers
Brief Summary: The purpose of this study is to compare a regimen of tenofovir/lamivudine/lopinavir-ritonavir to the WHO-recommended and locally practiced standard of care regimen consisting of zidovudine/lamivudine/lopinavir-ritonavir during the second and third trimesters of pregnancy in HIV and HBV co-infected women. This is a phase II study evaluating the safety of the test regimen in pregnant women and their newborns. While the study is not powered to examine efficacy, preliminary estimates of transmission of HIV and HBV to the infants and of the rate of resistance development will be obtained.


Options:
A: Arm Label: Continuous quality improvement (CQI); Type: EXPERIMENTAL; Interventions: Other: Continuous quality improvement | Arm Label: Standard of care; Type: NO_INTERVENTION; Interventions: N/A | Intervention Type: OTHER; Name: Continuous quality improvement; Assigned to Arm(s): Continuous quality improvement (CQI)
B: Arm Label: E/C/F/TAF; Type: EXPERIMENTAL; Interventions: Drug: E/C/F/TAF | Arm Label: Stay on Baseline Treatment Regimen (SBR); Type: ACTIVE_COMPARATOR; Interventions: Drug: E/C/F/TDF, Drug: EFV/FTC/TDF, Drug: RTV, Drug: ATV, Drug: FTC/TDF, Drug: COBI | Intervention Type: DRUG; Name: E/C/F/TAF; Assigned to Arm(s): E/C/F/TAF | Intervention Type: DRUG; Name: E/C/F/TDF; Assigned to Arm(s): Stay on Baseline Treatment Regimen (SBR) | Intervention Type: DRUG; Name: EFV/FTC/TDF; Assigned to Arm(s): Stay on Baseline Treatment Regimen (SBR) | Intervention Type: DRUG; Name: RTV; Assigned to Arm(s): Stay on Baseline Treatment Regimen (SBR) | Intervention Type: DRUG; Name: ATV; Assigned to Arm(s): Stay on Baseline Treatment Regimen (SBR) | Intervention Type: DRUG; Name: FTC/TDF; Assigned to Arm(s): Stay on Baseline Treatment Regimen (SBR) | Intervention Type: DRUG; Name: COBI; Assigned to Arm(s): Stay on Baseline Treatment Regimen (SBR)
C: Arm Label: Antepartum Arm A; Type: ACTIVE_COMPARATOR; Interventions: Drug: Zidovudine (ZDV), Drug: Nevirapine (NVP): Antepartum Mothers, Drug: Emtricitabine-tenofovir disoproxil fumarate (Truvada [TRV]) tail, Drug: Nevirapine (NVP): Infant short-course | Arm Label: Antepartum Arm B; Type: EXPERIMENTAL; Interventions: Drug: Lamivudine-Zidovudine (3TC-ZDV), Drug: Lopinavir-ritonavir (LPV-RTV), Drug: Nevirapine (NVP): Infant short-course | Arm Label: Antepartum Arm C; Type: EXPERIMENTAL; Interventions: Drug: Lopinavir-ritonavir (LPV-RTV), Drug: Emtricitabine-tenofovir disoproxil fumarate (Truvada [TRV]), Drug: Nevirapine (NVP): Infant short-course | Arm Label: Late Presenters; Type: OTHER; Interventions: Other: No Intervention | Arm Label: Postpartum Arm A (Maternal Prophylaxis); Type: EXPERIMENTAL; Interventions: Drug: Lopinavir-ritonavir (LPV-RTV), Drug: Emtricitabine-tenofovir disoproxil fumarate (Truvada [TRV]), Drug: Nevirapine (NVP): Infant short-course | Arm Label: Postpartum Arm B (Infant Prophylaxis); Type: EXPERIMENTAL; Interventions: Drug: Nevirapine (NVP): Infant extended | Arm Label: Maternal Health Arm A (Continue triple ARVs); Type: EXPERIMENTAL; Interventions: Other: Continue triple ARVs | Arm Label: Maternal Health Arm B (Discontinue triple ARVs); Type: ACTIVE_COMPARATOR; Interventions: Other: Discontinue triple ARVs | Intervention Type: DRUG; Name: Zidovudine (ZDV); Assigned to Arm(s): Antepartum Arm A | Intervention Type: DRUG; Name: Nevirapine (NVP): Antepartum Mothers; Assigned to Arm(s): Antepartum Arm A | Intervention Type: DRUG; Name: Emtricitabine-tenofovir disoproxil fumarate (Truvada [TRV]) tail; Assigned to Arm(s): Antepartum Arm A | Intervention Type: DRUG; Name: Lamivudine-Zidovudine (3TC-ZDV); Assigned to Arm(s): Antepartum Arm B | Intervention Type: DRUG; Name: Lopinavir-ritonavir (LPV-RTV); Assigned to Arm(s): Antepartum Arm B, Antepartum Arm C, Postpartum Arm A (Maternal Prophylaxis) | Intervention Type: DRUG; Name: Emtricitabine-tenofovir disoproxil fumarate (Truvada [TRV]); Assigned to Arm(s): Antepartum Arm C, Postpartum Arm A (Maternal Prophylaxis) | Intervention Type: DRUG; Name: Nevirapine (NVP): Infant short-course; Assigned to Arm(s): Antepartum Arm A, Antepartum Arm B, Antepartum Arm C, Postpartum Arm A (Maternal Prophylaxis) | Intervention Type: DRUG; Name: Nevirapine (NVP): Infant extended; Assigned to Arm(s): Postpartum Arm B (Infant Prophylaxis) | Intervention Type: OTHER; Name: No Intervention; Assigned to Arm(s): Late Presenters | Intervention Type: OTHER; Name: Discontinue triple ARVs; Assigned to Arm(s): Maternal Health Arm B (Discontinue triple ARVs) | Intervention Type: OTHER; Name: Continue triple ARVs; Assigned to Arm(s): Maternal Health Arm A (Continue triple ARVs)
D: Arm Label: Standard of Care; Type: ACTIVE_COMPARATOR; Interventions: Drug: Zidovudine/lamivudine/lopinavir-ritonavir | Arm Label: Tenofovir; Type: EXPERIMENTAL; Interventions: Drug: Tenofovir/lamivudine/lopinavir-ritonavir | Intervention Type: DRUG; Name: Tenofovir/lamivudine/lopinavir-ritonavir; Assigned to Arm(s): Tenofovir | Intervention Type: DRUG; Name: Zidovudine/lamivudine/lopinavir-ritonavir; Assigned to Arm(s): Standard of Care

Answer: D