Anti-HIV Drugs for Treating Infants Who Acquired HIV Infection at Birth
Trial end date:
SummaryThe 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.
Accepts Healthy Volunteers?No
National Institute of Allergy and Infectious Diseases (NIAID)
CriteriaInclusion 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
- 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
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
- Inability to tolerate oral medication
- Birth weight less than 2 kg (4.4 lbs)