Please select the eligibility criteria that correspond to the clinical trial below.
Title: Extended Infant Post-exposure Prophylaxis With Antiretrovirals to Reduce Postnatal HIV Transmission
Brief Summary: The purpose of this study is to determine if extended antiretroviral regimens given to the infant during the first 14 weeks of age would decrease breast milk transmission of HIV.


Options:
A: Inclusion Criteria:

* Had given birth within the last 24 hours
* Ability and willingness to give informed consent for HIV testing and enrollment into the study
* Willing to receive HIV results
* HIV infected
* Planning to deliver or had given birth at the study clinics
* Willing to come back for follow-up visits for 2 years postnatally
* Resident of Blantyre city or its suburbs

Exclusion Criteria:

* HIV negative
* Women with discordant HIV results
* Women who indicate that they will not breastfeed at time of delivery
* Inability or unwillingness to follow any of the inclusion requirements
* Newborn with life-threatening condition
* Women who previously enrolled in this study and have a second pregnancy cannot reenroll
B: 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.
C: Inclusion Criteria:

Recruitment and primary eligibility criteria:

* Age \> 14 years.
* Ability to give informed assent or consent.
* Evidence of HIV infection, as documented by 2 positive ELISA antibody tests; or 1 positive ELISA, and 1 Western Blot; or 2 separate concurrent rapid tests.
* Currently pregnant (with a single or multiple fetuses).
* Gestation \< 30 weeks at referral from 'Call to Action' Program
* No serious current complications of pregnancy.
* Intention to breastfeed.
* Intention to deliver at the institution at which the study is based.
* Not previously enrolled in this study for an earlier pregnancy.
* 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.
* Mother's CD4 count \> 250 cells/uL determined in the antenatal clinic.
* Mother's ALT \< 2.5 x ULN (upper limit of normal) determined in the antenatal clinic

Secondary eligibility criteria and treatment assignment:

* Mother who delivers outside of the institution at which the study is based must present with her infant to the study site within 36 hours of delivery.
* Mother accepts nevirapine and zidovudine+lamivudine 7-day regimen for herself and her infant.
* Infant birth weight \> 2000 g.
* No severe congenital malformations or other condition(s) not compatible with life.
* Based on clinical assessment, no maternal condition which would preclude the start of the study intervention.
D: Inclusion Criteria:

* Pregnant between 32-36 weeks estimated gestation
* HIV Infected
* Intent to breastfeed infant
* Certain laboratory criteria. More information on this criterion can be found in the protocol.

Exclusion Criteria:

* Sensitivity to immune globulin preparations or any benzodiazepine
* Clinically significant disease, as determined by the investigator, that would compromise the ability of the participant to complete the study requirements
* Currently receiving antiretroviral therapy (other than the intrapartum NVP or other peripartum regimens)
* Participation in any HIV vaccine trials
* History of cytotoxic chemotherapy within one month of study entry
* Uncontrolled hypertension
* Chronic alcohol or illicit drug use
* History of non-compliance with visits or medication
* Women who become pregnant again during study follow-up will not be eligible for re-enrollment in the trial

Answer: A