Please select the eligibility criteria that correspond to the clinical trial below.
Title: Lopinavir/Ritonavir/Combivir vs. Abacavir/Zidovudine/Lamivudine for Virologic Efficacy and the Prevention of Mother-to-Child HIV Transmission Among Breastfeeding Women With CD4 Counts Greater Than or Equal to 200 Cells/mm3 in Botswana
Brief Summary: Anti-HIV drug regimens have dramatically improved the rates of prevention of mother-to-child transmission (MTCT) of HIV in developed countries. However, little is known of the effectiveness of such regimens in developing countries, such as Botswana. This study will determine whether Trizivir (TZV), a single pill containing abacavir sulfate, lamivudine, and zidovudine (ABC/3TC/ZDV), or lopinavir/ritonavir (LPV/r) and lamivudine/zidovudine (3TC/ZDV) is more effective in reducing HIV-1 viral load and preventing MTCT among HIV infected pregnant women in Botswana.


Options:
A: 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.
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:

* 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 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

Answer: D