Please select the eligibility criteria that correspond to the clinical trial below.
Title: ARVs to Prevent Breastmilk HIV:Viral and Immune Responses
Brief Summary: Identifying new approaches for preventing breastmilk transmission of HIV-1 is an important research priority. To this end, clinical trials are underway to evaluate the efficacy of HAART (zidovudine, lamivudine, nevirapine) during late pregnancy/lactation versus zidovudine/nevirapine peripartum for prevention of breastmilk HIV-1 transmission. It is important to understand the mechanism of effect of these antiretroviral (ARV) strategies on prevention of breastmilk HIV-1 transmission.

This phase II trial will compare HAART vs peripartum zidovudine/nevirapine for effect on breastmilk HIV-1, breastmilk HIV-1 specific immune responses, and infant HIV-1 specific immune responses.

100 pregnant HIV-1 seropositive women in Nairobi with CD4 counts between 200 to 500 who have chosen to breastfeed will receive either ARV regimen. Mother-infant pairs will be followed for 1 year after delivery. Home visits will be conducted in the first month (\~10 visits) to collect 2-5 mls of breastmilk per visit. Mother-infant pairs will be seen in the study clinic with maternal blood and breastmilk and infant blood collected at months 1, 3, and 6 for HIV-1 and HIV-1 Elispot assays. Breastmilk HIV-1 RNA and DNA levels will be quantified in Dr. Overbaugh's laboratory in Seattle and Elispot assays conducted in Nairobi with validation of a subset in Dr. Rowland-Jones laboratory in Oxford. Viral loads, decay curves, half-life, and re-population following ARV cessation will be estimated for each regimen and regimens compared. These studies will provide insight into the viral and immune responses to ARV regimens proposed for prevention of breastfeeding HIV-1 transmission and will be important for rational design of future interventions. After taking into account, estimated loss to follow-up, the targeted sample size with outcome data was 80 women, 40 in each trial arm, estimating undetectable breast milk HIV-1 RNA levels in the HAART arm and median breast milk HIV-1 RNA levels of 3.0 log10 in women receiving ZDV/NVP.


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:

* 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
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: D