Please select the eligibility criteria that correspond to the clinical trial below.
Title: A Phase III Randomized Clinical Trial of the Standard Two Dose Nevirapine (NVP) Regimen With the Addition of HIV Immune Globulin(HIVIGLOB) or Extended Infant NVP Dosing Compared With the Standard NVP Regimen Alone for the Prevention of Maternal-Infant HIV Transmission in Uganda
Brief Summary: The increase in pediatric HIV infection has a substantial impact on childhood mortality in the developing world. A number of recent studies suggest that as many as half or more of mother-to-child HIV transmissions in developing countries occur in late pregnancy or during labor and delivery. Interventions targeted during the perinatal period have shown to be effective and to have a significant impact in reducing transmission. The purpose of this study is to investigate the effectiveness of nevirapine (NVP) plus immunoprophylaxis or extended NVP dosing regimens in HIV-infected pregnant women and their infants during the perinatal period.


Options:
A: 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.
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 Mothers:

* HIV-infected
* At least at 26th week of pregnancy (treatment group) or 18th week of pregnancy (observational group) but not beyond the 34th week of pregnancy
* Able to complete study visits until at least 6 months postpartum
* Citizen of Botswana

Exclusion Criteria for Mothers:

* Taken ARVs for more than 1 week, other than ZDV, during current or prior pregnancy. Women who have received single-dose NVP in a prior pregnancy are not excluded.
* Certain abnormal laboratory values
* Plan to formula feed
* Known fetal abnormalities that suggest the fetus will not survive to 6 months of gestational age
* Known allergy or medical contraindication to any of the study drugs
* Require certain medications
* Previous participation in the "Prevention of Milk-Borne Transmission of HIV-1C in Botswana" (Mashi) study
* Currently incarcerated
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: D