Please select the eligibility criteria that correspond to the clinical trial below.
Title: A Phase III Trial to Determine the Efficacy and Safety of an Extended Regimen of Nevirapine in Infants Born to HIV-Infected Women to Prevent Vertical HIV Transmission During Breastfeeding
Brief Summary: The many benefits of breastfeeding are well documented. However, because of the risk of mother-to-child transmission (MTCT) of HIV from an HIV infected mother to her infant, there is considerable concern over the practice, especially in developing countries. The purpose of this study is to determine the safety and effectiveness of the anti-HIV drug nevirapine (NVP) in preventing MTCT of HIV in breastfeeding infants born to HIV infected women in South Africa, Tanzania, Uganda, and Zimbabwe.


Options:
A: Note: As of 08/10/07, the arm assignments for current and new participants have changed. Please see the above description for this trial for more information.

Inclusion Criteria for Mothers:

* 18 years of age or older
* HIV infected
* In third trimester of pregnancy, or at most 3 days post-delivery
* If baby is not yet born, planning to deliver at a facility where the study is being conducted
* Plan to breastfeed

Exclusion Criteria for Mothers:

* Complications with this pregnancy
* Serious medical condition that would interfere with the study (e.g., that would prevent breastfeeding or adherence to the follow-up schedule), as judged by the on-site clinician

Inclusion Criteria for Infants:

* Born to an HIV infected mother who is eligible for the study
* Weighed at least 2000 grams (4.4 lbs) at birth
* Blood sample obtained from the infant for HIV-1 DNA PCR, CBC with differential, and ALT
* Infants in a multiple birth are eligible only if both/all infants are eligible for the study and assigned to the same study group
* Able to breastfeed (e.g., mother and infant alive with no condition apparent that would prevent breastfeeding)

Exclusion Criteria for Infants:

* HIV DNA PCR positive at birth
* ALT of Grade 2 or higher at birth
* Hemoglobin, absolute neutrophil count, or platelet count of Grade 3 or higher at birth
* Skin rash of Grade 2B (urticaria), Grade 3, or above
* Confirmed or suspected clinical hepatitis
* Serious illness or condition that would interfere with compliance with study procedures
B: 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
C: 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
D: 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

Answer: A