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1991.03.26 :  AIDS Study -- Effectiveness of Peptide T

Contact: Linda Anderson (301) 443-4536
March 26, 1991

     The National Institute of Mental Health today announced the
beginning of a clinical study of the effectiveness of Peptide T,
a drug of potential value in treating the neuropsychological
effects of HIV infection and AIDS.
     "This is the first study designed to answer questions about
the effectiveness of Peptide T by comparing the compound to a
placebo in a controlled study design," said Alan I. Leshner,
Ph.D., NIMH acting director.
     The first patient started treatment with Peptide T in mid-
March.  The study is being conducted at the University of
Southern California in Los Angeles, and is being jointly
sponsored by NIMH and the National Institute of Allergy and
Infectious Diseases.
     The human immunodeficiency virus (HIV or AIDS virus) is
believed to cause problems of concentration and memory in some
persons with AIDS and AIDS-related complex by directly affecting
the brain.
     Peter N.R. Heseltine, M.D., the principal investigator,
said, "In earlier studies, people with these problems have shown
improvement in tests of their mental function, when they were
treated with Peptide T.  The purpose of this new study is to
discover if Peptide T is safely able to reduce these HIV-caused
problems of concentration and memory, and if it is safe and
effective when used with the antiretroviral AZT (zidovudine)."
     Commenting on the start of the trial, Frederick K. 
Goodwin, M.D., administrator of the Alcohol, Drug Abuse, and
Mental Health Administration, said, "It is deeply gratifying to
me that an agent developed by NIMH shows promise of benefiting
people who are at risk from one of the most devastating diseases
ever to affect mankind.  While in vitro studies showed mixed
results regarding the antiretroviral activity of this agent,
early clinical studies of Peptide T have been encouraging, and
this agency is fully committed to exploring the value of this
drug in treating the neuropsychological effects of HIV infection
and AIDS."
     Ellen Stover, Ph.D., director of the NIMH Office of AIDS
Programs, said, "This is the first time that a trial of an AIDS
therapeutic will be using improvement in mental functioning as
the key outcome.  We are working toward making progress in
treating HIV infection, and are looking forward to the
collaboration with USC investigators and the results of this
study."
     Peptide T was developed by NIMH scientists working at the
institute's research facilities on the National Institutes of
Health campus in Bethesda, Md.  The peptide is an artificially
produced protein that blocks the attachment of the AIDS virus to
human cells by occupying receptors on the cell surface.  Its
structure is similar to part of the protein coat of HIV.
     In the Phase II study, a minimum of 150 men and women who
have been infected with HIV will be enrolled in the double-blind,
placebo-controlled trial.  (Phase II studies are designed
primarily to test the efficacy of new therapies.)
     The investigators are making special efforts to enroll women
and minorities, who have been underrepresented in some earlier
AIDS studies.
     Initially, participants will receive either Peptide T or
placebo for six months, and then during the second six-month
period, all study participants will receive the peptide.  During
the one-year study, participants may take any Food and Drug
Administration-approved medications for prevention of AIDS-
related opportunistic infections, and they may continue treatment
with antiviral therapies if they are taking them when they enter
the study.
     A steering committee composed of NIMH and NIAID staff,
community representatives and experts on AIDS clinical trials,
neuropsychological testing, and statistics will provide oversight
and review of the clinical trial for safety, data analysis and
related issues.
     Individuals interested in participating in the study may
call Charles Hovis, LAC-USC Medical Center, 213-226-4643, or the
PHS-sponsored AIDS Clinical Trials Information Service, 1-800-
TRIALS-A.
     The National Institute of Mental Health is part of the
Alcohol, Drug Abuse, and Mental Health Administration.  The
National Institute of Allergy and Infectious Diseases is a part
of the National Institutes of Health.  These offices and the Food
and Drug Administration are among the components of the Public
Health Service family of health agencies within the Department of
Health and Human Services.


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