Please select the eligibility criteria that correspond to the clinical trial below.
Title: Evaluation of the Safety and Efficacy of Dihydroartemisinin-piperaquine for Intermittent Preventive Treatment of Malaria in HIV-infected Pregnant Women
Brief Summary: Trial to evaluate the safety and efficacy of DHA-PPQ for Intermittent Preventive Treatment (IPTp) in HIV-infected pregnant women receiving cotrimoxazole prophylaxis (CTXp) and antiretroviral (ARV) drugs and using long lasting insecticide treated nets will be conducted in Mozambique and Gabon where malaria and HIV infection are moderate to highly prevalent. In addition, the possibility for a PK interaction between DHA-PPQ and ARV drugs will be assessed in a sub-sample of participants. Women will receive ARV therapy according to national guidelines and their infants will be followed until one year of age to evaluate the impact of DHA-PPQ on MTCT-HIV.


Options:
A: Inclusion Criteria:

* Permanent resident in the study area
* Gestational age at the first antenatal visit ≤ 28 weeks
* HIV seropositive status
* Agreement to deliver in the study site's maternity(ies) wards

Exclusion Criteria:

* Residence outside the study area or planning to move out in the following 10 months from enrolment
* Gestational age at the first antenatal visit \> 28 weeks of pregnancy
* Known history of allergy to CTX
* Known history of allergy or contraindications to DHA-PPQ
* Participating in other intervention studies
B: Inclusion Criteria:

1. Pregnancy confirmed by positive urine pregnancy test or intrauterine pregnancy by ultrasound
2. Estimated gestational age between 12-20 weeks
3. Confirmed to be HIV uninfected by rapid test
4. 16 years of age or older
5. Residency within 30km of the study clinic
6. Provision of informed consent by the pregnant woman for herself and her unborn child
7. Agreement to come to the study clinic for any febrile episode or other illness and avoid medications given outside the study protocol
8. Plan to deliver in the hospital

Exclusion Criteria:

1. History of serious adverse event to SP or DP
2. Active medical problem requiring inpatient evaluation at the time of screening
3. Intention of moving more than 30km from the study clinic
4. Chronic medical condition requiring frequent medical attention
5. Prior SP preventive therapy or any other antimalarial therapy during this pregnancy
6. Early or active labor (documented by cervical change with uterine contractions)
C: Inclusion Criteria:

* First or second pregnancy
* Greater than 16 weeks gestation
* Less than 28 weeks gestation
* Consent for HIV testing

Exclusion Criteria:

* Less than 15 years old
D: Inclusion Criteria:

* Confirmed pregnancy (through palpable fundus and/ or positive pregnancy test)
* Gestational age between 16 and 28 weeks.
* Informed consent by patient (or parent/ guardian if patient is less than 18 years of age)
* No symptoms consistent with malaria
* Willingness to deliver at the health facility
* Willingness to adhere to all requirements of the study (including HIV-1 testing)

Exclusion Criteria:

* History of allergy to study drugs, or previous history of allergy to sulpha drugs
* History or presence of major illnesses likely to influence pregnancy outcome including diabetes mellitus, severe renal or heart disease, or active tuberculosis, prior to randomization;
* Any significant illness that requires hospitalization;
* Intent to move out of the study catchment's area before delivery or deliver at relative's home out of the catchment's area;
* Prior enrolment in the study or concurrent enrolment in another study
* Severe anaemia (Hb\<7 g/dl)
* Previous history of unfavourable pregnancy outcome: pre-eclampsia, caesarean section, stillbirth.
* Being HIV infected and already receiving CTX prophylaxis or ARV treatment

Answer: A