Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: Reducing the Burden of Malaria in HIV-Infected Pregnant Women and Their HIV-Exposed Children (PROMOTE Birth Cohort 2)
Brief Summary: This is a double-blinded, randomized controlled trial of 200 HIV-infected pregnant women living in Tororo, Uganda, an area of high malaria transmission. HIV-infected pregnant women between 12 and 28 weeks gestation will be randomized to receive enhanced malaria chemoprevention with monthly dihydroartemisinin-piperaquine (DP) versus monthly DP placebo. Their HIV-exposed children will receive the same prevention regimen from 2 to 24 months of age to which the mothers were randomized. All women will receive daily trimethoprim-sulfamethoxazole (TS) throughout the study per Uganda Ministry of Health guidelines. Children will also receive daily TS from 6 weeks to 24 months of age. TS will be considered a study drug only in infants and children beginning 6 weeks after cessation of breastfeeding and upon exclusion of HIV infection. Women and their children will be followed for 36 months after delivery. In a subset of the study population, the investigators will conduct an intensive pharmacokinetic study that will evaluate pharmacokinetic exposure of DP and EFV. The investigators will also measure HIV-related outcomes among the women enrolled in the study. The investigators will test the hypothesis that for HIV-infected mothers and HIV-exposed infants, that enhanced versus standard malaria chemoprevention in HIV-infected pregnant women and their children will reduce the incidence of malaria among children from 0 to 24 months of age and improve the development of naturally acquired antimalarial immunity.


Options:
A: Arm Label: IPTp-DHA-PPQ; Type: EXPERIMENTAL; Interventions: Drug: Dihydroartemisinin-piperaquine (DHA-PPQ) | Arm Label: IPTp-Placebo; Type: PLACEBO_COMPARATOR; Interventions: Drug: Placebo Oral Tablet | Intervention Type: DRUG; Name: Dihydroartemisinin-piperaquine (DHA-PPQ); Assigned to Arm(s): IPTp-DHA-PPQ | Intervention Type: DRUG; Name: Placebo Oral Tablet; Assigned to Arm(s): IPTp-Placebo
B: Arm Label: Daily TS + Monthly DP pregnancy; Type: ACTIVE_COMPARATOR; Interventions: Drug: Monthly dihydroartemisinin-piperaquine (DP) + daily trimethoprim/sulfamethoxazole (TS) | Arm Label: Daily TS + DP Placebo pregnancy; Type: PLACEBO_COMPARATOR; Interventions: Drug: Monthly placebo + daily trimethoprim/sulfamethoxazole (TS) | Intervention Type: DRUG; Name: Monthly dihydroartemisinin-piperaquine (DP) + daily trimethoprim/sulfamethoxazole (TS); Assigned to Arm(s): Daily TS + Monthly DP pregnancy | Intervention Type: DRUG; Name: Monthly placebo + daily trimethoprim/sulfamethoxazole (TS); Assigned to Arm(s): Daily TS + DP Placebo pregnancy
C: Arm Label: Trial 1: IPTp-SP+LLITNs; Type: ACTIVE_COMPARATOR; Interventions: Drug: Sulphadoxine-pyrimethamine | Arm Label: Trial 1: IPTp-MQ (full dose) + LLITNs; Type: EXPERIMENTAL; Interventions: Drug: Mefloquine (full dose) | Arm Label: Trial 1: IPTp-MQ (split dose)+LLITNs; Type: EXPERIMENTAL; Interventions: Drug: Mefloquine (split dose) | Arm Label: Trial 2: CTX+IPTp-Placebo+LLITNs; Type: EXPERIMENTAL; Interventions: Drug: placebo | Arm Label: Trial 2: CTX + IPTp-MQ+ LLITNs; Type: EXPERIMENTAL; Interventions: Drug: mefloquine | Intervention Type: DRUG; Name: Sulphadoxine-pyrimethamine; Assigned to Arm(s): Trial 1: IPTp-SP+LLITNs | Intervention Type: DRUG; Name: Mefloquine (full dose); Assigned to Arm(s): Trial 1: IPTp-MQ (full dose) + LLITNs | Intervention Type: DRUG; Name: Mefloquine (split dose); Assigned to Arm(s): Trial 1: IPTp-MQ (split dose)+LLITNs | Intervention Type: DRUG; Name: placebo; Assigned to Arm(s): Trial 2: CTX+IPTp-Placebo+LLITNs | Intervention Type: DRUG; Name: mefloquine; Assigned to Arm(s): Trial 2: CTX + IPTp-MQ+ LLITNs
D: Intervention Type: DRUG; Name: Sulfadoxine-Pyrimethamine (Fansidar); Assigned to Arm(s): N/A | Intervention Type: DEVICE; Name: ITNs; Assigned to Arm(s): N/A

Answer: B