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:

* 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.
B: Inclusion Criteria:

* HIV infection, documented on two separate specimens
* Estimated gestational age at enrollment of 32 weeks or more as indicated by last menstrual cycle and fundal height
* Permanent residency in Addis Ababa
* Plan to deliver at a hospital affliated with the study (Tikur Anbessa Hospital, Gandhi hospital, or St. Paul's Hospital)
* Hemoglobin \>= 7.5 gm/dl within 4 weeks prior to study entry
* Serum glutamic pyruvic transaminase (SGPT) \< 5 times upper limit of normal within 4 weeks prior to study entry
* Serum creatinine \< 1.5 mg/dl within 4 weeks prior to study entry
* Consent form signed by the mother and, when possible, by the father, prior to the onset of labor
C: Inclusion Criteria:

* HIV-positive pregnant women identified through VCT
* After counseling about the risks and benefits of feeding alternatives report that it is their intended decision to breastfeed
* Live within the catchment area of George or Chawama clinic
* Are between 30 - 34 wks gestation. (To insure that opportunity exists to receive a minimum of 2 lactation counseling sessions prior to delivery)
* Do not have any significant presenting illness that requires hospitalization
* Agree to adhere to the requirements of study participation (including exclusive breastfeeding and randomization into one of two infant feeding groups at four months).
* Willing to inform a household member (preferably husband/father) of HIV-status.

Exclusion Criteria:

* Lives outside of catchment area;
* Have known major illnesses likely to influence pregnancy outcome including diabetes, severe renal or heart disease, or active tuberculosis, prior to randomization;
* Does not intend to breastfeed;
* Prior enrollment in this study or concurrent enrollment in another study
D: 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)

Answer: D