Please select the eligibility criteria that correspond to the clinical trial below.
Title: Protease Inhibitors to Reduce Malaria Morbidity in HIV-Infected Pregnant Women
Brief Summary: This study is an open-label, single site, randomized controlled trial comparing protease inhibitor (PI)-based antiretroviral therapy (ART) to non-PI based ART for HIV-infected pregnant and breastfeeding women of all CD4 cell counts at high risk of malaria. The study is designed to test the hypothesis that pregnant women receiving a PI-based ART regimen will have lower risk of placental malaria compared to pregnant women receiving a non-PI based ART regimen. The primary study endpoint of the study is placental malaria. This study also enrolls the infants of these women at the time of delivery.


Options:
A: Inclusion Criteria:

* signed informed consent from at least one guardian
* age 6.00 months to 14.99 months
* weight-for-age \<-2.0 Z scores
* availability during the period of the study.
* permanent resident Lungwena Health Centre catchment area

Exclusion Criteria:

* moderate or severe wasting (WHM\<80% of the reference median)
* history of peanut allergy
* history of any serious allergic reaction to any substance, requiring emergency medical care
* history of anaphylaxis
* severe illness warranting hospital referral
* concurrent participation in another clinical trial with intervention to the child
B: Inclusion Criteria:

1. Age \> 16 years (if \<18 years old, living independently from parents)
2. Documentation of HIV status must come from two assays. Assays include DNA PCR, HIV RNA, Western blot, or rapid HIV antibody test
3. Confirmed pregnancy by positive serum or urine pregnancy test or ultrasound
4. Estimated gestational age between 12 and 28 weeks (based on first day of last menstrual period with physical exam confirmation and ultrasound confirmation) at time of enrollment
5. Residency within 30 km of the study site
6. Willing to provide informed consent

Exclusion Criteria:

1. Current or prior use of HAART
2. Exposure to single-dose NVP (alone or with zidovudine or zidovudine/lamivudine or other abbreviated monotherapy or dual therapy for PMTCT) less than 24 months prior to enrollment
3. Prior dose-limited toxicity to TS within 14 days of study enrollment
4. Receipt of any contraindicated medications within 14 days of study enrollment (See Appendix III.)
5. Active tuberculosis or other WHO Stage 4 diseases
6. Screening laboratory values:

   1. Hemoglobin: \<7.5 g/dL (Note: Women found to have a hemoglobin \<7.5 at screening may receive iron and folic acid and/or a blood transfusion at the physician's discretion. If a repeat hemoglobin is ≥7.5 g/dL, the woman may be considered for study inclusion.)
   2. Absolute neutrophil count (ANC): \<750/mm3
   3. Platelet count: \<50,000/mm3
   4. ALT: \>225 U/L (\>5.0x ULN)
   5. AST: \>225 U/L (\>5.0x ULN)
   6. Bilirubin (total): \> 2.5x ULN
   7. Creatinine: \> 1.8x ULN
7. Known cardiac conduction abnormalities or structural heart defect

NOTE: A woman will be excluded from study participation during the current pregnancy if she goes into labor, experiences ruptured membranes or develops active tuberculosis or a WHO stage 4 condition following study enrollment but prior to study drug initiation.
C: Inclusion Criteria:

* HIV infected
* CD4 count \> 200 cells/μL
* ALT \< 2.5 x upper limit of normal (ULN)
* Hemoglobin (Hb) \> 7 g/dL
* Age \> 18 years, or \<18 years and married (considered emancipated minors in Malawi)
* Ability to give informed consent
* Evidence of HIV infection, as documented by 2 positive Enzyme-Linked Immunosorbent Assays (ELISA's); or 1 positive ELISA, and 1 Western blot (WB); or 2 separate concurrent rapid tests. These are the World Health Organization (WHO) acceptable criteria for diagnosing HIV-1 infection in adults.
* Currently pregnant (with a single or multiple fetuses)
* Gestation \< 34 weeks
* No serious current complications of pregnancy
* Intention to breastfeed
* Intention to deliver at the institution in which the study is based
* Other than HIV, no active serious infection, such as tuberculosis or other potentially serious illnesses
* No previous use of antiretrovirals including the HIVNET 012 regimen
D: Inclusion Criteria:

* Infants 6 to 12 months old
* Lives in Fort San Michel

Exclusion Criteria:

* Moderately or severely malnourished
* Peanut allergy

Answer: B