3rd Conf Retro and Opportun Infect. 1996 Jan 28-Feb 1;:173. Unique
The Pediatric AIDS Clinical Trials Group is a multi-center collaborative
group sponsored by NIAID and NICHD. Clinical trials of antiretroviral
therapy are one important objective of the organization. Current Phase
III trials include ACTG 300 [Zidovudine (ZDV) + Lamivudine (3TC) vs. ZDV
+ Didanosine (ddI) vs. ddI monotherapy in antiretroviral treatment naive
children], ACTG 239 [ddI vs. ZDV + ddI in HIV infected infants less than
or equal to 2 months old], ACTG 240 [ZDV vs. Stavudine (D4T) in
antiretroviral naive children less than or equal to 6 years old], and
ACTG 245 [ZDV + ddI vs. ddI + Nevirapine (NVP) vs. ZDV +ddI +NVP in
previously treated children with advanced HIV disease]. Phase I studies
are underway or in development for 3TC + ZDV in infants (ACTG 321); for
Adefovir dipivoxil (bis-POM PMEA) (ACTG 310); for ddI plus Ribavirin
(ACTG 274); and for 1592U89 (a nucleoside analog RT inhibitor). An
ongoing Perinatal Prophylaxis trial, ACTG 185, compares ZDV to ZDV +
HIV-specific immune globulin (HIVIg). Phase I studies of NVP (ACTG 250)
and ddI (ACTG 249) in pregnancy are open to accrual. A template-based
protocol is being designed to expedite the virologic evaluation of
combination regimens and new antiretroviral drugs in HIV infected
children.
Acquired Immunodeficiency Syndrome/*DRUG THERAPY Antiviral
Agents/ADMINISTRATION & DOSAGE/*THERAPEUTIC USE Child Child, Preschool
Clinical Trials Clinical Trials, Phase I Clinical Trials, Phase II
Clinical Trials, Phase III Drug Therapy, Combination Human Infant
ABSTRACT