Please select the eligibility criteria that correspond to the clinical trial below.
Title: Intermittent Preventive Treatment of Malaria With Sulfadoxine-Pyrimethamine in HIV-Seropositive and HIV-Seronegative Pregnant Women in Zambia
Brief Summary: Prevention of malaria in pregnancy is critical given the high incidence of malaria in Zambia and its serious impact on both maternal and infant survival. Intermittent presumptive treatment with sulfadoxine-pyrimethamine has been shown to be highly efficacious for reducing the risk of malaria in pregnancy. However, based on a study done in western Kenya, HIV-infected pregnant women may need more frequent dosing of SP, i.e., on a monthly basis rather than the standard 2-dose regimen given during the second and third trimesters, as HIV appears to reduce the effectiveness of the SP drug combination. The goal of this study was to evaluate the efficacy of the standard dosing regimen in comparison to an intensive monthly SP dosing schedule in HIV-positive women.


Options:
A: Inclusion Criteria:

* HIV-positive pregnant women between 16-28 weeks of gestation identified through VCT
* HIV-negative pregnant women between 16-28 weeks of gestation identified through VCT
* Residence within the catchment area of the health facility
* Willing to deliver at the health facility
* Willing to agree to adhere to the requirements of study participation (including monthly ANC visits and willing to allow all study procedures)
* Willing to provide written informed consent
* Aged 18 years and above

Exclusion Criteria:

* Severe anemia (Hb \< 6 g/dL)
* History of allergic reactions to sulfa drugs
* History of known pregnancy complications (e.g. breech presentation, severe pre-eclampsia, prior caesarian section)
* 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 presenting illness that requires hospitalization
* Intent to move out of the study catchment area before delivery or deliver at relative's home out of the catchment area
* Prior enrollment in the study or concurrent enrollment in another study
B: 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
C: Inclusion Criteria:

* Man and non-pregnant women aged between 15 and 50.
* P.falciparum mono-infection of at least 1,000 parasites/µl.
* Body temperature ≥ 37.5°C at the moment of enrolment or history of fever in the preceding 48 hrs.
* Consent from patient obtained.

Exclusion Criteria:

* Pregnancy.
* Severe P. falciparum malaria .
* Documented intake of SP or Coartem two weeks or less prior recruitment.
* Other cause(s) of fever.
* Evidence of underlying chronic diseases (cardiac, renal, hepatic, malnutrition).
* History of allergy to study drug, or known allergy to other Sulphur drugs such as co-trimoxazol.
D: Inclusion Criteria:

* Gestational age of at least 16 weeks.
* P. falciparum parasitaemia of any density with or without symptoms.
* Informed consent.
* No known adverse reaction to any of the study drugs.
* Residence in the study area.

Exclusion Criteria:

* Past obstetric and medical history that might adversely affect the interpretation of outcomes such as repeated stillbirths and eclampsia.
* History of severe adverse drug reactions to co-trimoxazole in the past.
* Haemoglobin concentration below 5.0 g/dl.
* Severe malaria.

Answer: A