ACTG Highlights

SELECTED RESEARCH ACCOMPLISHMENTS

Antiretroviral Research
AZT was shown in 1986, in a Burroughs Wellcome Co.-sponsored study, to prolong the lives of
persons with AIDS and was licensed for this use in 1987. Stll, many questions remained about
how best it should be used, and about its effectiveness in othi HIV-infected adults and
children. NIAID-supported studies of AZT have resulted in longer, healthier lives for hundreds
of thousands of HIV-infected adults and children, by providing vital information about how best
to use AZT alone and in combination with other drugs. MAID is currently supporting both
efficacy studies and phase I studies of several other promising antiretroviral agents.
AZT: Demonstrated that both high and low dose AZT are effective in delaying
progression to more advanced disease in asymptomatic individuals.
Demonstrated that the previous standard dose of AZT is effective in preventing
progression of disease in patients with early ARC.
Demonstrated that low dose AZT (600 mg/day) is at least as effective as standard
dose and is less toxic.
Demonstrated that at even lower doses of AZT (300 mg/day), p24 antigen
decreases and CD4 cell counts increase.
Demonstrated good tolerance of AZT in HIV-i.fected persons with hemophilia.
Demonstrated that probenecid prolongs the half life of AZT, permitting lower
daily AZT doses (and therefore lower cost) wii n equal effect.
Demonstrated no synergistic or additive effects of the combination of acyclovir
and AZT.
Demonstrated that high dose IL-2 in combinati en with AZT improves
immunological parameters.
Preliminary analysis suggests that the combination of AZT and ddC has the same
effect on p24 antigen and CD4 cell counts but is less toxic than continuous
therapy with AZT.
Demonstrated no pharmacokinetic interaction b tween AZT and high or low dose
trimethoprimlsulfamethoxazole.
Completed phase I and phase II trials of AZT n children; studies were the basis
for approval by FDA.
Implemented the Treatment IND of AZT for c ildren in collaboration with
Burroughs Wellcome.
Determined the pharmacokinetics and safety profile of AZT for children between
1 day and 3 months.