Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: Prevention of Mother-to-child Transmission of Hepatitis B Virus: a One Arm, Open Label Intervention Study to Estimate the Optimal Timing of Tenofovir (TDF) in Pregnancy
Brief Summary: Mother-to-child transmission (MTCT) of hepatitis B virus (HBV) remains the major mode of transmission in most high and intermediate HBV endemic areas, despite existing WHO immunoprophylaxis recommendations. This immunoprophylaxis regimen, if given optimally, can prevent 75-80% of HBV MTCT, but optimal implementation is difficult because it requires administering monovalent HBV vaccine and hepatitis B immunoglobulin (HBIg) within 24 hours of birth. Due to the barriers of giving HBIg, the World Health Organization (WHO) states, "...owing to concerns related to supply, safety and cost, the use of HBIg is not feasible in most settings." Clearly, global control of HBV transmission will require improved MTCT prevention. Therefore, the investigators hypothesize that treating HBV early in pregnancy will lead to undetectable HBV DNA levels at delivery and prevention of MTCT of HBV without HBIg; a concept that has already been proven with HIV. Tenofovir disoproxil fumarate (TDF), an approved anti-HBV drug, is promising to prevent MTCT of HBV due to its high potency against hepatitis B and its safety record in pregnant women. A randomized, controlled clinical trial (RCT) will be necessary to determine if TDF given to HBV-infected pregnant women early in pregnancy plus vaccine to the newborn can decrease MTCT of HBV without HBIg. However, before embarking on a RCT, several critical knowledge gaps need to be addressed including the ideal timing for TDF initiation. The purpose of this proposal is to address these knowledge gaps.


Options:
A: 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)
B: Arm Label: Tenofovir Disoproxil Fumarate; Type: EXPERIMENTAL; Interventions: Drug: Tenofovir Disoproxil Fumarate | Intervention Type: DRUG; Name: Tenofovir Disoproxil Fumarate; Assigned to Arm(s): Tenofovir Disoproxil Fumarate
C: Arm Label: 2A; Type: EXPERIMENTAL; Interventions: Drug: Nevirapine | Arm Label: 2B; Type: PLACEBO_COMPARATOR; Interventions: Drug: Nevirapine placebo | Intervention Type: DRUG; Name: Nevirapine; Assigned to Arm(s): 2A | Intervention Type: DRUG; Name: Nevirapine placebo; Assigned to Arm(s): 2B
D: 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)

Answer: B