Clinical Trial Review, no. 3

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Kaposi's Sarcoma:
TNP-470
TNP-470 prevents the growth of
new blood vessels which cause tumors (cancer). TNP-470 is a synthetic version of lumagillin, a substance which is obtained from a fungus called Aspergillus fumigatusfresenius. In 1990, it was discovered
that TNP-470 was able to block the
factors and cells which cause new
blood vessels to grow. So far, the
drug has worked against cancers in
test-tube and animal studies.
In this Phase I study (92-c-0228)
participants will receive TNP-470 by
infusion every other day for 4 weeks,
for one hour. After a 2 week rest,
they will receive the drug for another
6 weeks. Other groups of patients
will receive higher doses of the drug
until the highest tolerable dose is
determined. You must stay in the
National Institutes of Health Clinical
Center for the first two weeks of the
study.
To participate in this trial, you must
be 18 or older, HIV+ and have KS.
You must currently be on a stable
dose of an antiviral drug such as AZT
or ddl. You cannot be pregnant,
have pulmonary KS, or life-threatening KS that is treatable with other
drugs.
Your KS lesions cannot be bleeding
or located in a critical area. Additionally, you cannot have serious peripheral neuropathy, be taking anticonvulsants, or have a history of seizures (in the past ten years). Medications that are not allowed while on
therapy include steroids, NSAIDS,
anticoagulants, or drugs that may
effect bleeding.

CMV Disease Treatment
CMV is adisease caused by a herpesvirus with which many people have been
infected sometime during their lifetime. A major research goal is to control or
prevent CMV disease. Even if you are already infected with the CMV virus,
you should be careful to avoid repeatexposure. Your besttreatment strategy
is to maintain a T4 cell count above 50 or, if your count falls below 50, to use
medication to prevent reactivation of latent (inactive) CMV virus. The majority
of people with HIV disease have been exposed to CMV at some point in their
life. There are no approved treatments for the prevention of CMV disease.
The following four studies are designed to determine dosage and efficacy of
different drugs for both prevention and treatment. Call The Network if you
qualify and are interested in participating in any of these studies.
CMV Prevention
ACTG 204 is a trial to see if 256U can prevent CMV disease in body organs.
256U is a prodrug of acyclovir, which means that it turns into acyclovir when
in gets into the body. It is hoped that this drug will reach the affected areas in
a concentrated form to prevent CMV. Everyone in this study will receive
acyclovir, in either a high dose or a low dose. They will then receive, by
chance, either 8000 mgs a day of 256U or 3200 mgs a day of 256U. This will
be an outpatient study (you do not have to go into the hospital to stay).
To participate in this trial, you must be 13 years or older, HIV+, and have less
than 100 T4 cells. You must have antibodies to CMV and have been stable
for at least 30 days on all drugs you might be taking for HIV and opportunistic
infections. Prior use of ganciclovir, foscarnet, or any investigational anti-CMV
agent is not allowed. Other exclusions include nausea or vomiting that
prevents you from swallowing or absorbing the drug in pill form; pregnancy;
and treatment with interferons or immunomodulators (other than Procrit or
Neupogen).
HMPC for CMV Disease
HPMPC is an antiviral drug similar to AZT, ddl and ddC. It is active against
herpesviruses in lab studies. A phase 1/11 study is underway at the Mt. Zion
Medical Center in San Francisco and at NIAID (National Institute of Allergies
and Infectious Disease) in Bethesda, MD.
This is an open-label, dose-ranging trial to determine the safety and tolerance
levels of the drug. An open-label trial is one where there is no placebo control
and both the person giving and person getting the drug know what they are
taking. Dose ranging means that different amounts of the drug will be given
to determine which amount is most effective within the limits of safety.
Volunteers in this trial are people who are infected with the CMV virus but do
not have symptoms.

AIDS Treatment Data Network

February 1993

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