Announcements: Recent Clinical Trials Recruiting

Mark Jacobson, M.D., at San Francisco General Hospital,
brought several trials for HIV, and for KS, to our attention.
All but one of these trials is recruiting in several cities
(not only in San Francisco).

None of these trials is listed by the AIDS Clinical Trials
Information Service (at phone number 800/TRIALS-A). This is
because 800/TRIALS-A, a Federally-sponsored service, lists
all Federally-sponsored AIDS trials, but only some privately-
sponsored ones. Trials sponsored by a pharmaceutical company
are only listed if the company agrees, and goes to the
trouble to provide the information.

[When trials are not listed, it can be difficult to find
information by calling the companies directly; it took us
about two days' work to find and confirm the listings below.
One company refused to give us any information, even the
names of the cities where the trial would take place, until
they had authorization from the investigators at the sites,
which would take them ten working days; we got the
information elsewhere. Most gave us the information, but
usually it took a number of calls to find it, even when we
started with a number given out for that purpose. And
sometimes the sponsors give different contact numbers than
the sites themselves. Only a few companies have, coherently
and in one place, all the information potential volunteers
will need to find a trial site near them (if there is one).
Since recruiting volunteers is the biggest problem for most
clinical trials, anyone conducting a trial should at least
pay attention to making it easy to find.]

Note: Not all of the entry criteria for these trials are
listed below. Clinical trials often have many
inclusion/exclusion criteria, most of which apply only to a
few patients. The notices below only list the requirements
which are most likely to exclude potential volunteers, so
that readers can get a quick idea of whether or not they
might qualify.

** HIV: Alpha Interferon, T-Helper Above 500

This trial is studying whether low or moderate doses of alpha
interferon can slow HIV progression in early infection. The
theory behind the trial is that there are two kinds of T-
helper immune response, Th1 (cellular immunity, with cells
attacking and destroying infected cells) and Th2 (which leads
to production of antibodies). For HIV, the Th1 response seems
to be most important; and the Th2 response, when it occurs,
may reduce the Th1 response. Alpha interferon may increase
Th1 activity and/or decrease Th2 activity. If these theories
are correct, it might help to prevent progression of HIV
disease. (AIDS TREATMENT NEWS published an advance notice of
this potentially important trial in issue #179, July 23,
1993.)

Alpha interferon has been used as a treatment in HIV disease
since early in the epidemic, but has not been systematically
studied in early infection. There is reason to believe that
early use might be most beneficial, since without treatment
the Th1 response is lost before a major decline in T-helper
cell count occurs.

Volunteers must be HIV positive, with T-helper count over
500, and must never have used AZT or other antiretrovirals.
They will be tested and must be deficient in one or more of
three measures of Th1 response (recall antigens,
alloantigens, or PHA) -- apparently so that the trial will
have some way to measure treatment success. There are a
number of other inclusion/exclusion criteria.

Those accepted will be randomly assigned to one of three
groups: 0.2 million units of interferon (Intron A) three
times a week, 2.0 million units three times a week, or an
untreated control group. The drug is given by subcutaneous
injection. The treatment will be continued for 12 weeks, and
there will be two later followup visits. This trial is
sponsored by Schering Corporation.

The sites are: Denver (University of Colorado, contact
Virginia Waite, B.S.N., 303/270-8340; the trial should begin
at the Denver site within the next few weeks); Durham (Duke
University, contact Robert Dodge, R.N., 919/684-5260); and
San Francisco (San Francisco General Hospital, contact Linda
Johnson, R.N., 415/476-9296 x84099).

Comment

Alpha interferon is an approved drug, and any physician can
prescribe it. The doses being tested in this trial are low to
moderate. The disadvantage of using the drug outside of the
trial is that until the study is done, nobody knows if this
treatment will be useful. Also, the drug is expensive, and
does have side effects.

** HIV: ddI Plus d4T Combination, T-Helper 200-500, No Prior
Antiretrovirals

This trial, sponsored by Bristol-Myers Squibb, will test five
different combination regimens of two anti-HIV drugs: ddI
(didanosine), which is approved; and d4T (stavudine), which
is in late stages of human testing and also currently in use
through parallel track. This study will look first at the
safety of the combination, since both drugs can cause
peripheral neuropathy. But it will also measure antiviral
activity using a number of tests: acid-dissociated p24
antigen, beta-2 microglobulin, PBMC viral titers, and HIV RNA
and DNA PCR. Development of resistant viruses will also be
measured.

Volunteers must have T-helper counts from 200-500, and must
never have received AZT, ddI, ddC, or d4T. This is a pilot
study, which will only enroll a total of 75 volunteers.

This study will require approximately 12 visits to the clinic
over a period of one year.

The four study sites are: Galveston (the University of Texas,
contact Bernadette Montgomery, 409/772-3991); Los Angeles
(UCLA, contact Suzette Chafey, 310/206-6414); New York
(Cornell Medical Center, contact Jim Mahoney, 212/746-4177);
and San Francisco (San Francisco General Hospital, contact
Ted Bush, R.N., 415/476-9296 ext. 84098).

** HIV: Nevirapine+AZT, T-Helper 200-500, 4-12 Months Prior
AZT

This study will compare the combination of AZT plus
nevirapine (formerly called BI-RG-587) with AZT alone, to see
if the combination can reduce viral measures (HIV RNA, and
viral cultures) and increase T-helper cell count and T-helper
cell percent, after three and six months of treatment. All
patients will continue on AZT throughout the study; and those
initially assigned to placebo will be switched to open-label
nevirapine during the trial.

Volunteers must have T-helper counts of 200-500, and must
have used AZT for at least four months, and no more than 12
months, immediately before entering the study. They cannot
have CDC-defined AIDS, and also cannot have certain HIV-
related conditions.

This trial will be conducted in five cities: Baltimore (Johns
Hopkins University Hospital, contact Becky Becker, R.N., or
Louis Grue, R.N., 410/955-2898); Chicago (Northwestern
University Medical School, contact Pam Donath, R.N., 312/908-
9636); Galveston (University of Texas Medical Branch, contact
Bernadette Montgomery, R.N., 409/772-0361); San Francisco
(San Francisco General Hospital, contact Kathy Dybeck, R.N.,
415/476-9296 x84097); and St. Louis (Washington University
School of Medicine, contact Mark Myers, 314/454-0058). The
trial is sponsored by Boehringer Ingelheim


** HIV: ddC Plus AZT, T-Helper Count 100-500, No Prior
Antiretrovirals

This large study, enrolling over 500 patients at over 20
sites, is comparing different doses and schedules of AZT and
ddC used in combination. There is no placebo, and all
volunteers enrolled will get both drugs. The AZT doses are
500 mg per day (100 mg every four hours while awake) vs. 600
mg per day (200 mg every 8 hours); the ddC doses are 0.75 mg
every eight hours, and 0.375 mg every eight hours. This trial
is sponsored by Hoffmann-La Roche.

Volunteers must have a T-helper count between 100 and 500,
and not have had any previous treatment with AZT, ddI, ddC,
or d4T. They also must not have symptoms of peripheral
neuropathy at the time of the trial, or any history of
peripheral neuropathy of grade 2 or greater.

This trial is being conducted at sites in the following
cities: Albuquerque, Boston, Bronx, Brooklyn, Chicago, St.
Louis, Columbus, Dallas, Denver, Galveston, Harbor City, CA,
Miami (2 sites), Milwaukee, New York, Portland, OR, San
Diego, San Francisco, St. Paul, Washington (2 sites), and
Wichita. For more information about volunteering, call
800/526-6367 teleprompt 2 to be referred to a site near you.

** Kaposi's Sarcoma: Recombinant Platelet Factor 4 (rPF4),
San Francisco Only

This phase I/II trial, sponsored by Repligen, is being
conducted only at San Francisco General Hospital. In a
previous study, shrinkage of KS lesions was found in six out
of 12 patients who were treated with rPF4 by direct injection
into the lesions. This new trial will test the drug for
systemic treatment, giving it in six-hour intravenous
infusions. The trial is looking for evidence of safety, and
also for activity of the drug on KS, either on the skin or
internally.

Volunteers must have biopsy-proven KS, and be clinically
stable.

For more information, contact Carol Arri, R.N., 415/476-9296,
ext. 84094.

** Kaposi's Sarcoma: Pentoxifylline

There are theoretical reasons to believe that pentoxifylline
(Trental), an approved drug, might have some activity against
KS. This trial, sponsored by Hoechst-Roussel, is to make sure
it is safe to combine pentoxifylline with antiretroviral
drugs patients are already using, and to look for evidence of
clinical activity of pentoxifylline, either against KS, or
against the progression of HIV infection itself. [For
background on pentoxifylline as a possible HIV treatment (not
focused on KS), see AIDS TREATMENT NEWS # 156, August 7,
1992.] Nausea has been the most common side effect found so
far.

To enroll in this trial, volunteers must have relatively mild
KS, not be likely to need chemotherapy during the study, and
have had no KS treatment during the last 30 days. There are
separate slots for persons with T-helper counts over 200 and
under 200; the latter are almost full, at least at the San
Francisco site, so it may be easier for persons with over 200
to enroll.

The trial will be conducted at three sites in two cities: Los
Angeles (UCLA, contact Ashley at the Care Facility, 310/206-
6414); Los Angeles (Norris Cancer Hospital, contact their
clinical-trials information office, 800/5-CANCER); and San
Francisco (San Francisco General Hospital, contact Julie
Russell, R.N., 415/476-9296 ext. 84100).