Please select the eligibility criteria that correspond to the clinical trial below.
Title: A Phase III, Randomized, Open-Label Trial to Evaluate Strategies for Providing Antiretroviral Therapy to Infants Shortly After Primary Infection in a Resource Poor Setting
Brief Summary: The purpose of this study is to compare the effects of anti-HIV drug courses of different lengths in infants who became HIV infected at birth.


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:

* 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
C: Inclusion Criteria for Infants:

NOTE: Per Letter of Amendment dated 04/04/07, Part B of this study is no longer recruiting participants. Per Letter of Amendment dated 09/16/08 Arm 1 of this study is longer recruiting.

* HIV infected
* Antiretroviral naive. Infants who have previously received antiretroviral drugs used to prevent mother-to-child transmission are eligible for the study.
* Parent or legal guardian willing to provide informed consent and comply with study requirements

Exclusion Criteria for Infants:

* Any major life-threatening congenital abnormalities
* Severe CDC Stage B or C disease
* Liver enzyme, absolute neutrophil count, hemoglobin, electrolyte, creatinine, or clinical toxicity of Grade 3 or higher at screening
* Any acute or clinically significant medical event that would preclude participation in the study. Randomization can take place as soon as the incurrent illness has resolved if the child is still less than or equal to 12 weeks of age.
* Use of investigational drugs
* Require certain medications. More information on this criterion can be found in the protocol.
* Inability to tolerate oral medication
* Birth weight less than 2 kg (4.4 lbs)
D: Inclusion Criteria for All Participants:\>\>

* age \>=6 months to \< 36 months (decreased to 2 months in protocol version 4.0)\>\>
* HIV infected\>\>
* Viral load greater than 5,000 copies/ml within 60 days of study entry\>\>
* Treatment naive except for antiretrovirals (ARV) used to prevent MTCT (infant ARV use for \<=1 week postpartum for prevention of MTCT allowed) \>\>
* Eligible for treatment according to WHO pediatric algorithm (updated in protocol version 1.0, Letter of amendment (LOA)#1) and protocol version 2.0, LOA#3). Subjects with active opportunistic infections were not eligible for study participation until they had been treated and were clinically stable \>\>
* Parent or legal guardian willing to provide signed informed consent\>\>

Inclusion Criteria for Cohort I:\>\>

* Documentation of maternal or infant NVP exposure or a highly reliable verbal report. (Updated in protocol version 2.0, LOA#3 to require written clinic/hospital documentation of infant exposure to SD NVP)\>\>
* Use of maternal ARV, including NVP, permitted during pregnancy\>\>
* One or more of the following: strict formula feeding, initial infant HIV diagnosis occurring while younger than 60 days of age, or an initial AIDS-defining illness diagnosis by WHO criteria while younger than 60 days of age. \>\>

Inclusion Criteria for Cohort II:\>\>

* Use of maternal ARVs, excluding NNRTIs, permitted during pregnancy\>\>
* Evidence of lack of prior NVP exposure (added in protocol version 2.0, LOA#3) by review of maternal and child medical records or health card (or other written documentation) for evidence of NVP exposure to mother or infant during pregnancy, labor, and delivery. If no written documentation showing lack of NVP use was shown in these records or if these records were not available for review, then a verbal report considered to be highly reliable by the study nurse was acceptable AND one or more of the following: \>\>

  1. Study subject born before single dose NVP was available for prevention of MTCT of HIV in the location of birth of study subject\>\>
  2. Study subject born before the biological mother's first positive HIV test\>\>
  3. Site staff had another reason to believe the subject had not been exposed to NVP \>\> \>\> Exclusion Criteria for All Participants:\>\>
* Grade 2 or higher aspartate aminotransferase (AST) or alanine aminotransferase (ALT) at study screening\>\>
* Grade 3 or higher laboratory toxicity at study screening\>\>
* Received ARVs for anything other than the prevention of intrapartum MTCT. Infants who received ARVs after the first week of life (e.g., for the prevention of MTCT of HIV through breastfeeding) were excluded \>\>
* Acute serious infections requiring active treatment. Subjects could be receiving treatment for active TB if it did not include rifamycin drugs\>\>
* Receiving chemotherapy for an active tumor\>\>
* History of a cardiac conduction abnormality and underlying structural heart disease\>\>
* Required certain medications\>\> \>\> Exclusion Criteria for Cohort I: \>\>
* History of or currently breastfeeding. Breastfed infants with a positive HIV test or who had experienced an AIDS-defining illness by WHO criteria at 60 days of age or younger were not excluded\>\>

Exclusion Criteria for Cohort II:\>\>

* Exposure to any maternal NVP or other NNRTI prior to or during the pregnancy or while breastfeeding\>\>
* Exposure of infant to NVP at any time including during the first week of life

Answer: C