Please select the eligibility criteria that correspond to the clinical trial below.
Title: Prevention of Maternal to Infant HIV Transmission in India
Brief Summary: Infants who are breast-fed by HIV infected mothers have an increased risk of becoming infected with HIV. Standard therapy for the prevention of HIV infections in infants included zidovudine (ZDV) prior to the onset of labor, a single dose of nevirapine (NVP) for women during labor, and a single dose of NVP for newborns given 72 hours after birth. This study will determine if giving low dose daily NVP to breastfed infants of HIV infected mothers, in addition to standard therapy, will be more effective than standard therapy alone at preventing HIV infections in these infants.


Options:
A: Inclusion Criteria:

1. Be a pregnant HIV-infected female presenting prior to 34 weeks gestation who has already chosen to breastfeed after receiving counseling on infant feeding choices according to UNAIDS guidelines which includes counseling and education about the overall benefits of breast feeding as well as the risks of HIV transmission to the infant inherent in breastfeeding.
2. Report that they plan to reside in Kisumu for the next 2 years
3. Be able to give competent, informed consent if \>18 or have a parent or guardian who can do the same in the case of a minor.
4. Be willing to comply with study requirements if they meet study eligibility criteria.
5. Meet the following laboratory criteria at enrollment (Efforts will be made to address potentially correctable abnormalities such as anemia, prior to enrollment)

   1. Documentation of HIV-1 infection according to the Kenyan National PMCT testing algorithm.
   2. Serum creatinine \<1.5 mg/dl
   3. Hgb \>7.0 g/dL
   4. Absolute neutrophil count \> 1000 cells/ml
   5. Platelet count \>50,000/ml
   6. SGPT \< 2.5 times upper limit of normal
   7. Documentation of CD4 count results prior to beginning study drug; which will be used to determine the appropriate HAART regimen -i.e ZDV/3TC/NVP or ZDV/3TC/NLF
   8. Documentation of Hepatitis B and C infection status (Hepatitis B surface antigen and Hepatitis C antibody)
6. Have signed consent and met clinical and laboratory eligibility criteria in order to be enrolled in the trial by 34-36 weeks gestation (preferably at 34 weeks).

Exclusion Criteria:

1. Is participating in other HIV vaccine or antiretroviral trials.
2. Has substantial hypersensitivity to any benzodiazepine, including Nevirapine.
3. Has history of prior substantial intolerance or severe allergic reaction to Nevirapine, Zidovudine, Lamivudine or Nelfinavir.
4. For women who will be placed on NVP, ongoing treatment with rifampin, anticoagulants, benzodiazepines, and magnesium sulfate at time of planned enrollment. For those women who will be placed on NLF, ongoing treatment with amiodarone, quinidine, ergot derivative drugs, rifampin, pimozide, St John's work, lovastatin, simvastatin, midazolam or triazolam
5. Has evidence of clinically significant cardiac, respiratory, hepatic, gastrointestinal, endocrine, hematologic, psychiatric, neurologic, or allergic disease that would compromise the ability of the participant to complete the study or the study requirements as determined by the principal investigator or designated associate. The clinical significance of any abnormality is to be evaluated in the context of the safety of the patient volunteer and the objectives of this study.
6. Has a history of cytotoxic chemotherapy within one month prior to study entry or current diagnosis of malignancy for which systemic therapy is expected to be required during the period of study.
7. Blood pressure \> 160 mm Hg systolic or \> 110 mm Hg diastolic.
8. Chronic alcohol or illicit drug use.
9. Women who become pregnant again during the study follow-up will NOT be eligible for re-enrollment in the trial if they were enrolled for their previous pregnancy.
B: Inclusion Criteria:

* Mothers must be no more than 34 weeks pregnant, intending to carry to term, intending to stay in area for at least 7 months, and consenting to HIV-1 testing and participation; HIV-1 infected by ELISA confirmed by Western blot; etc.
C: Inclusion Criteria for Pregnant or Postpartum Mothers

* HIV infected
* Planning to breastfeed
* Able to tolerate oral drugs and available for 12 months of postpartum follow-up

Exclusion Criteria

* Significant physical or emotional distress
* Infant with serious or life threatening disease or severe fetal abnormality
* Obstetrical complications affecting maternal health
* Prior antiretroviral drugs (except antenatal ZDV or intrapartum (NVP)
D: Inclusion Criteria:

* The subject population is recruited from Mathare North Clinic in Nairobi, Kenya where voluntary HIV-1 counseling and testing is offered to pregnant women
* Pregnant women who test positive for HIV-1 antibody are eligible for the study if they are over 18 years of age
* At less than 32 weeks' gestation
* Have never previously been exposed to antiretroviral medications
* Agree to serial maternal blood
* Breast milk
* Infant blood draws
* Plan to live in Nairobi for at least a year after delivery.

Exclusion Criteria:

* CD4 \>500 or \<200
* Not planning to live in Nairobi after delivery
* Not planning to breastfeed.

Answer: C