Please select the eligibility criteria that correspond to the clinical trial below.
Title: A Phase I/II Study of Lopinavir/Ritonavir in HIV-1 Infected Infants Less Than 6 Months of Age
Brief Summary: The purpose of this study is to find out if the drug lopinavir/ritonavir (LPV/RTV) is safe and well tolerated in HIV infected infants. This study will also determine the most effective dose of LPV/RTV for infants.


Options:
A: Inclusion Criteria

* HIV infected
* Viral load greater than 10,000 copies/ml within 30 days prior to study entry
* Weigh more than 5.5 lbs at the time of enrollment
* Agree to take 2 nucleoside reverse transcriptase inhibitors (NRTIs) in addition to LPV/RTV
* Have consent of parent or guardian willing to provide signed informed consent and to have the infant followed at a PACTG site

Exclusion Criteria

* Currently taking a nonnucleoside reverse transcriptase inhibitor or protease inhibitor (PI) while on study
* Previously used LPV/RTV. Patients who were treated previously with other PIs are not excluded. Prior or concurrent maternal treatment with LPV/RTV is not excluded.
* For patients less than 6 weeks old at time of enrollment, less than 34 weeks gestation at delivery OR for patients 6 or more weeks old at time of enrollment, less than 32 weeks gestation at delivery
* Any laboratory toxicity of Grade 3 or greater. Hyperlipasemia of Grade 2 or higher is also excluded.
* Newly diagnosed acute opportunistic or serious bacterial infection requiring therapy at the time of enrollment
* Chemotherapy for active cancer
* Certain medications
* Any other clinically significant conditions, other than HIV infection, that would interfere with the study
B: Inclusion Criteria:

* HIV-1 infected
* Antiretroviral naive, defined as never receiving anti-HIV medications, receiving them for less than 7 days, or only receiving them to prevent mother-to-child transmission (MTCT)
* CD4% between 15 and 24 within 30 days prior to study entry
* CDC pediatric clinical classification A or B
* Parent or guardian willing to provide informed consent and willing to follow all study procedures and requirements

Exclusion Criteria:

* Use of systemic chemotherapy, immunomodulators, HIV vaccines, immune globulin, interleukins, or interferons within 30 days prior to study entry
* Active AIDS-defining illnesses (CDC Category C) within 30 days prior to study entry
* Certain abnormal laboratory values
* Known kidney disease
* Known allergy or sensitivity to study drugs
* Require certain medications
* Pregnancy
C: 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.
D: Inclusion Criteria:

* NVP-exposure as part of pMTCT-prophylaxis around delivery
* HIV-positive
* Eligible for treatment
* Plans to stay in the area for the next 6 months

Exclusion Criteria:

* Already on anti-retroviral treatment
* History of toxicity to perinatal NVP
* Grade 3 or greater elevation of liver function tests
* Being treated for a severe acute opportunistic infection or tumor

Answer: A