August 3, 1989


ZIDOVUDINE BENEFITS PERSONS WITH EARLY SYMPTOMATIC HIV 

INFECTION


     Zidovudine, commonly called AZT, significantly slows 

progression of HIV infection when given to persons with 

early AIDS-related complex (ARC), according to results from 

a placebo-controlled, multicenter clinical trial supported 

by the National Institute of Allergy and Infectious Diseases 

(NIAID) in collaboration with Burroughs Wellcome Co.


     The results of the trial were announced today by 

Anthony S. Fauci, M.D., Director of the NIAID.  He reported 

that NIAID has stopped the study on the recommendation of 

the Data and Safety Monitoring Board reviewing the trial 

data.  The trial has been underway at 29 units of the NIAID 

AIDS Clinical Trials Group since August 1987.  All study 

participants will now be offered zidovudine.  The Board 

reviewed trial data at its regular meeting on August 2.


     "For the first time, the benefits of anti-retroviral 

treatment for patients with early symptomatic HIV infection 

have been clearly shown," Dr. Fauci said.  "In this study, 

significantly fewer persons receiving zidovudine progressed 

to advanced ARC or AIDS.  This finding could extend 

treatment to an estimated one to two hundred thousand 

persons with early symptoms of HIV infection.  It also 

emphasizes how critical it is that persons at risk for HIV 

infection be tested and seek prompt medical care."


     The randomized, double-blind trial was coordinated by 

Margaret Fischl, M.D., University of Miami.  It included 713 

HIV infected persons having T4 cell levels between 200 and 

800/mm3 and one or two HIV-associated symptoms, such as oral 

thrush, chronic rash, or intermittent diarrhea.  

Participants received either placebo or 200 milligrams of 

zidovudine every 4 hours (1200 milligrams per day) over a 

period of 3 to 20 months.  Fewer than 5 percent of the 

participants experienced serious side effects.


     As of July 1989, 50 of the 713 participants had 

progressed to advanced ARC or AIDS.  Of these, 36 

participants were in the placebo arm of the study, whereas 

only 14 were in the zidovudine arm.  The benefit of 

zidovudine was demonstrated only in those participants who 

had T4 cell counts between 200 and 500 when they entered the 

study.


     "This study clearly shows that early intervention is 

important in HIV infection and that zidovudine is well 

tolerated in persons with early ARC," Dr. Fischl said.


     Frank Young, M.D., Ph.D., Commissioner of the Food and 

Drug Administration said, "The FDA will work closely with 

the NIAID and Burroughs Wellcome Co. to translate these 

exciting results into wider availability of zidovudine to 

this category of symptomatic HIV-infected persons as quickly 

as possible."


     Zidovudine, whose chemical name is 

3'-azido-3'-deoxythymidine is manufactured by Burroughs 

Wellcome Co. and is available under the trademark Retrovir.  

Its effectiveness in extending the lives of persons with 

AIDS was first announced in September 1986.  It was approved 

in March 1987 for treatment of AIDS patients who had 

recovered from Pneumocystis carinii pneumonia and patients 

with advanced ARC.