Clinical Trials
The division is involved in several clinical trials, particularly those sponsored by the Pediatric AIDs Clinical Trials Group (PACTG). These currently include:
ACTG 219c
Pediatric Late Outcomes
ACTG 390
A phase II/III randomized open-label study of combination
antiretroviral regimens and treatment-switching strategies in
antiretroviral naive children 30 days and to 18 years of age.
Download Protocol Status Report (PDF)
ACTG 394
Safety of tenofovir disoproxil fumarate (TDF) in HIV infected pregnant women and their infants
ACTG 1006
The effects of highly active antiretroviral therapy (HAART) on the
recovery of immune function in HIV-infected children. (open to children
with less than15% CD4 cells who are initiating HAART or changing their
current HAART regimen).
Download Protocol Status Report (PDF)
ACTG 1020A
A phase I/II open-label, pharmacokinetic and safety study of a novel
protease inhibitor (BMS232632) in combination regimens in
antiretroviral naive and experienced HIV-infected infants, children,
and adolescents.
Download Protocol Status Report (PDF)
ACTG 1025
Perinatal core protocol (natural history study of pregnant women or
women who have delivered a live or stillborn child; postnatal follow-up
for 6 months postpartum).
Download Protocol Status Report (PDF)
ACTG 1030
A phase I/II study of lopinavir/ritonavir in HIV-1 infected infants <6 months of age.
Download Protocol Status Report (PDF)
ACTG 1038
A phase I/II safety, tolerability, and phamacokinetic study of high
dose lopinavir/ritonavir with or without saquinavir in HIV infected
pediatric subjects previously treated with protease inhibitors.
ACTG 1053
A phase II, randomized, open-label study to evaluate the safety and
effectiveness of two antiretroviral therapeutic strategies: a dual
pi-based-haart regimen versus a multi-nrti-art regimen, in
art-experienced children and youth who have experienced virologic
failure (pending)
ACTG 1055
Psychiatric co-morbidity in perinatally hiv-infected children and adolescents
ACTG 1059
A phase I, open-label study to evaluate the safety and tolerability of
recombinant HIV-1 vaccines in HIV-1 infected young adults with control
of HIV-1 replication and on stable highly active antiretroviral therapy
(haart) (pending)
ACTG 1061
Evaluation of immunologic memory following pneumococcal, hepatitis B,
and measles vaccination in HIV-infected children treated with highly
active antiretroviral therapy (haart)
ATN 015
Short-cycle therapy in adolescents following continuous therapy with
established viral suppression: the impact of viral load suppression
(pending)
Centers for Disease Control and Prevention-Sponsored Study
U64 CCU219448-05-1
Intervention epidemiologic research studies of HIV/AIDS
Gilead Sciences, Inc.-Sponsored Trial
GS-US-103-0518
The safety and efficacy of adefovir dipivoxil in children and adolescents with chronic hepatitis B
Schering-Plough, Inc.-Sponsored Trial
H12081
Assessment of the safety, efficacy, tolerability and pharmacokinetics
of peg-intron plus rebetol in pediatric patients with chronic hepatitis
C
Glaxo-Smith Kline, Inc.-Sponsored Trial
GW433908
Safety, tolerability, pharmacokinetics
Merck, Inc.-Sponsored Trial
H-9964-04B
A comparison of the safety and tolerabitiliy of a second dose m-m-r®ii
manufactured with recombinant human albumin (rHA) versus m-m-r®ii
manufactured with pooled-donor human serum albumin (has) in health
children 12 to 18 months of age
The division is also involved in the following clinical trials:
H12787
The effect of aldara cream on cutaneous leishmaniasis
10922-01
A registry of chronic viral hepatitis in new york city children
H12469-01
Hepatitis B registry and repository of the asian american hepatitis program
H-11076-02-A
Persistence of the immune response to vaccinia in immunocompetent and HIV-positive adults
