Announcements

** Children: NIH Begins First Pediatric Trial of Therapeutic
Vaccine

The U. S. National Institutes of Health is now running the
first trial of an HIV treatment vaccine for children. The
ultimate goal of this research is to find out if an HIV vaccine
can prevent children already infected with HIV from getting sick.

The study will enroll children between the age of one month
and 12 years. They must have well-documented HIV infection (many
infants who test HIV positive are not actually infected), but no
symptoms of HIV disease (or nothing other than swollen lymph
glands or a mildly swollen liver or spleen).

Three different vaccines are being studied: a gp160 vaccine
by MicroGeneSys, a gp120 vaccine by Genentech, and another gp120
vaccine (with a different adjuvant) by Biocine, a joint venture
of Chiron and CIBA-Geigy. An adjuvant is a substance added to a
vaccine to make it work better.

In each group of 15 children, 12 will be randomly assigned
to receive vaccine and three will receive a placebo (the adjuvant
only). If the vaccine is well tolerated, a higher dose will be
given to the next group of 15 children. This trial is looking
mostly for safety and immunological information; it is too small
to tell if one vaccine is more effective than another.

The trial will be conducted at 12 sites in the U.S. A total
of 90 children will be enrolled. Each child will receive six
immunizations -- one a month for six months -- and will then be
followed up for 24 months after the last shot.

For the site locations or other information about this
trial, call the AIDS Clinical Trials Information Service,
800/TRIALS-A, on weekdays from 9 a.m. to 7 p.m. Eastern time.
Spanish-speaking information specialists are available.

*** KS: DaunoXome Study Recruiting, Compassionate Use
Also Available

A phase III trial of liposomal daunorubicin (brand name
DaunoXome, being developed by Vestar, Inc., of San Dimas,
California), an experimental treatment for Kaposi's sarcoma (KS),
is now recruiting at nine cities in the U.S. This trial will
randomize patients to receive either liposomal daunorubicin, or
the conventional treatment ABV (adriamycin, bleomycin, and
vincristine).

In addition, a compassionate-use protocol is being started
in four cities.

Ordinary daunorubicin is an approved drug used in
chemotherapy for cancer. Its use is limited because of serious
toxicity, especially damage to the heart.

Liposomal daunorubicin (brand name DaunoXome) is
daunorubicin enclosed in liposomes, which are microscopic balls
of fat. Liposomes are used for targeted drug delivery, because
they can be designed to be differently absorbed by different
tissues. In trials so far, liposomal daunorubicin has been able
to deliver a higher concentration of the drug to tumors or to KS
lesions than free daunorubicin (not in liposomes), with less
toxicity, especially to the heart.

Terrence Chew, M. D., of HIVCare at St. Francis Memorial
Hospital, is running one of the two trial sites in San Francisco,
and the only compassionate-use site in that city. He has used
liposomal daunorubicin to treat patients for two years in early,
small studies, and has seen no evidence of cardiac toxicity.
However, hematologic toxicity is much like that of free drug, or
only slightly less. He has seen about 70 percent of patients
respond well to the drug -- about the same as with the
conventional treatment, ABV -- but feels that because there is
less toxicity with liposomal daunorubicin, the quality of life is
better.

The phase III comparative trial is actively enrolling
patients with five or more untreated KS lesions, who have never
had systemic chemotherapy. There are 200 slots in the trial.

Persons must have primary care before enrolling. There is
no charge for the trial, except that patients randomized to the
ABV arm of the study may need to pay for that drug, as Vestar
does not cover all of this cost. Persons interested in
volunteering can check with the site nearest them for further
information.

The clinical trial is being conducted in: Chicago,
Houston, Los Angeles, New York, Palm Springs, Portland, San
Francisco, Tucson, and Washington

The compassionate use program for advanced KS is for persons
who have failed conventional therapy. They must usually have 25
or more lesions (or ten new ones in a single month). As with
most compassionate-use protocols, patients are responsible for
the cost of laboratory and other tests, and drug administration;
only the drug is free. Each infusion visit (every two weeks)
costs about $250 at the site we checked, including a required
physical and drug preparation. This price may vary at different
sites. The compassionate-use program is available in: Boston,
Los Angeles, New York, and San Francisco.

For more information about the DaunoXome phase III trial,
call Jeanni Brenning at Vestar, 714/394-4000.

For more information about the compassionate-use protocol,
call Michelle Sample at PACT, 800/247-3303. PACT is
administering this program for Vestar.

** AIDS Health Fraud Congressional Hearing Set Quietly --
Postponed to May?

A hearing on AIDS health fraud, originally set for April 15,
has been postponed and may take place in May. As of May 3,
however, the date had not been set. The hearing will be before
the House Judiciary Committee Subcommittee on Crime and Criminal
Justice, chaired by Congressman Charles Schumer (Democrat,
Brooklyn).

AIDS TREATMENT NEWS learned about this hearing only by
chance on April 15, the date it was supposed to have occurred,
when our editor was on a panel with an FDA spokesperson who
happened to mention that an AIDS health fraud hearing had been
scheduled for that day but was being postponed. We called about
10 AIDS treatment activists across the country, and none of them
had heard of the hearing -- not even the policy department of the
Gay Men's Health Crisis, the leading AIDS organization in
Congressman Schumer's district. We do not know who has been
invited to testify, since the witness list is being kept
confidential until a few days before the hearing takes place.
And the new date remains uncertain because the Subcommittee has
been busy with the World Trade Center bombing in New York, the
events near Waco, Texas, and an upcoming national summit on drug
control.

We recently heard that the Subcommittee has been in contact
with two AIDS activist organizations. But neither of them had
known about the hearing until we told them -- after the date on
which it was supposed to have occurred.

These circumstances raise suspicion that there may be an
effort to create an unbalanced hearing, possibly to lay the
groundwork for future crackdowns against treatment options and
access -- the kinds of crackdown that could limit legitimate
treatment choices, as well as fraudulent, deceptive, or dangerous
ones. It may be important for AIDS organizations to attend the
hearing and make contact with any reporters who show up, to make
sure they know that there are well-informed, legitimate
viewpoints, and sources of well-documented information, which
may not otherwise be represented there. This press outreach will
not affect the record of the hearing, however; therefore, if the
content does turn out to be unbalanced, it will be necessary to
include a continuing effort to inform Congress and other parties
of that fact. Since AIDS TREATMENT NEWS probably cannot get to
Washington to attend the hearing, we hope that others will.

Meanwhile, outright AIDS treatment scams do exist (although
they seem considerably less common than we would have expected at
this stage of the epidemic). The Subcommittee may indeed have
enough horror stories of completely baseless, grossly overpriced,
or deceptively promoted treatments that it can stay well away
from legitimate unproven choices. In any case, persons who want
to tell the Subcommittee about cases of health fraud, AIDS-
related or otherwise, can write to: Charles E. Schumer,
Chairman, Subcommittee on Crime and Criminal Justice, 362 Ford
House Office Bldg., Washington, D. C. 20515.

** San Francisco: ACT UP/Golden Gate Treatment Issues
Committee Benefit, May 11

The American Association of Physicians for Human Rights, its
San Francisco area affiliate, and several dozen physicians,
dentists, and other health professionals are sponsoring a $100+
benefit reception for the ACT UP/Golden Gate Treatment Issues
Committee, to raise money for AIDS treatment activists to attend
medical conferences. The reception will be Tuesday May 11, 6 to
8 p.m., at the Cafe Majestic, 1500 Sutter Street in San
Francisco.

For many months the Treatment Issues Committee has been
doing excellent work which is complex and largely unknown to the
larger AIDS community. It has negotiated on many different
issues with pharmaceutical companies, public officials,
researchers, and others, to speed the most important initiatives
in AIDS research, make clinical trials more workable for patients
and physicians, ease the conditions for access to new treatment
options, and bring pressure to lower excessive prices.

Regardless of whether you can afford $100, or whether you
see this notice before the date has passed, you can come to the
Treatment Issues meeting every Thursday at 7:30 p.m., at the ACT
UP/Golden Gate workspace, 592 Castro Street (at the corner of
19th Street), on the 2nd floor. [This address may change because
there are often too many people to fit in the room; call the ACT
UP/Golden Gate voicemail announcement line, 415/241-8800, to
confirm the location.] Working with this group is a good way to
learn the latest news about treatments. Newcomers are sometimes
intimidated because they cannot follow much of the discussion at
first. The key is to realize that, of the dozen or more projects
that may be ongoing at any one time, you only need to find one
which interests you; it is not hard to learn enough about that
one area to be able to start contributing to the work of the
group.

** Alternative Medicine and Health-Care Reform Conference,
Washington, May 20-23

A four-day conference, "Alternative Medicine, Wellness, and
Health Care Reform: Preparing for a Sustainable Future," will
take place May 20-23 at the National Museum of Health and
Medicine and the Dirksen Senate Office Building in Washington, D.
C. It is sponsored by the NIH Office of Alternative Medicine (see
article in this issue), the National Museum of Health and
Medicine, the National Wellness Coalition, and the U.S. Botanic
Garden; co-sponsors are the Taoist Health Institute and the
Center for Natural and Traditional Medicine. Topics include the
future of alternative medicine in the U.S. ; improving health-
care access, delivery, and research; and over two dozen lectures
and panels on specific medical systems and other topics
(examples: "Homeopathy: The Art and Science"; "Attitudinal
Healing"; "Nutritional Approaches to the Treatment of Chronic
Disease"; "Traditional Chinese Pharmacopeia"; "Herbs, Nutritional
Supplements, and Government Regulations"; and "Holistic
Treatments for AIDS"). This is not an AIDS conference, but AIDS
is one area to be discussed.

Registration is $75 per day, $275 for four days (slightly
less if postmarked before May 14); discounts are available for
senior citizens, volunteers, and full-time students. For more
information, call EEI Conferences, Attn: Alison Malone,
703/684-2116.