NCT00001448 - Clinical Trial References

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Citation(s)

Epstein LG, Sharer LR, Oleske JM, Connor EM, Goudsmit J, Bagdon L, Robert-Guroff M, Koenigsberger MR
Neurologic manifestations of human immunodeficiency virus infection in children. Pediatrics. 1986 Oct;78(4):678-87.
Pressman H
Communication disorders and dysphagia in pediatric AIDS. ASHA. 1992 Jan;34(1):45-7.
Wolters PL, Brouwers P, Moss HA, Pizzo PA
Differential receptive and expressive language functioning of children with symptomatic HIV disease and relation to CT scan brain abnormalities. Pediatrics. 1995 Jan;95(1):112-9.

The Effect of Oral Candidiasis on the Speech Production, Feeding Skills, and Self-Concept of Children and Adolescents With Symptomatic HIV Infection

Clinical trial NCT00001448 - References