Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 2:15 AM
Ignite Modification Date:
2025-12-25 @ 2:15 AM
NCT ID:
NCT00102960
Eligibility Criteria:
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)
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
6 Weeks
Maximum Age:
12 Weeks
Study:
NCT00102960
Study Brief:
Protocol Section:
NCT00102960