[Release: Results of Controlled Clinical Trials of Zidovudine in Early HIV Infection] Page: 1 of 2
[2] p. ; 28 cm.View a full description of this text.
Extracted Text
The following text was automatically extracted from the image on this page using optical character recognition software:
S AIDS Clinical Trials Alert
National Institute of Allergy and Infectious Diseases
I
August 24, 1989
RESULTS OF CONTROLLED CLINICAL TRIALS OF ZIDOVUDINE
IN EARLY HIV INFECTION
Recently the National Institute of Allergy and Infectious Diseases announced
information about clinical trials of zidovudine (AZT) in HIV-infected individuals. These
studies have been conducted by NIAID's AIDS Clinical Trials Group. At this time, NIAID
is making no recommendation to physicians regarding clinical practice. However, the Institute
plans to convene a consensus conference in the near future to develop recommendations based
on the results of these studies. Meanwhile, NIAID wishes health care practitioners to have
additional information on these studies while publications are being readied for submission to
peer reviewed medical journals.
Protocol 019: Placebo-Controlled Trial in Asymptomatic HIV-Infected Persons
One study (Protocol 019), which enrolled more than 3,200 asymptomatic HIV-infected
volunteers, began approximately two years ago. The study has three arms comparing high
dose zidovudine (300 mg every 4 hours while awake, i.e., 1500 mg/day), low dose zidovudine
(100 mg every 4 hours while awake, i.e., 500 mg/day) and placebo. Volunteers were divided
into groups according to baseline T4 cell counts and randomized equally into the three
treatment arms. The endpoints of the study were development of AIDS or advanced ARC.
Followup ranged from 4 months to 2 years, with a mean duration of more than 1 year.
Data from the study were reviewed August 16, 1989, by a Data and Safety Monitoring
Board (DSMB) which found that in those participants with a baseline of <500 T4 cells who
received either dose of zidovudine, the rate of progression to AIDS or severe ARC was
roughly half that for participants with <500 T4 cells who received placebo. No significant
differences were seen in those persons receiving 500 mg/day versus those receiving 1500
mg/day with respect to onset of AIDS or advanced ARC.
The toxicity of zidovudine in patients with advanced HIV disease is well known. In
contrast, zidovudine toxicity experienced by the persons studied in Protocol 019 was minimal.
More important, with the exception of nausea that occurred in about 3 percent of the
volunteers, virtually no differences in side effects were observed in persons receiving the lower
dose and persons receiving placebo.
On the basis of these results, the DSMB recommended that the placebo arm of the
study be halted for participants with <500 T4 cells. Participants in this group have been
offered zidovudine (100 mg every 4 hours while awake). The study will continue for persons
with >500 T4 cells, since this study has shown that short-term risk of developing AIDS ismw
Upcoming Pages
Here’s what’s next.
Search Inside
This text can be searched. Note: Results may vary based on the legibility of text within the document.
Tools / Downloads
Get a copy of this page or view the extracted text.
Citing and Sharing
Basic information for referencing this web page. We also provide extended guidance on usage rights, references, copying or embedding.
Reference the current page of this Text.
National Institute of Allergy and Infectious Disease. [Release: Results of Controlled Clinical Trials of Zidovudine in Early HIV Infection], text, August 24, 1989; (https://texashistory.unt.edu/ark:/67531/metadc916919/m1/1/: accessed July 18, 2024), University of North Texas Libraries, The Portal to Texas History, https://texashistory.unt.edu; crediting UNT Libraries Special Collections.