Thymopentin (TP-5) Trial Starting, 34 U.S. Cities

This trial will test whether thymopentin (also called TP-5,
or Timunox), can slow the progression of HIV disease in AZT-
experienced persons.

Volunteers must be asymptomatic, with T-helper count from
100-400. They must have taken at least six months of prior
AZT, and upon entry into the study may be receiving AZT, ddI,
AZT+ddI, AZT+ddC, or no current antiretroviral treatment.
There are also some exclusion criteria, including oral
candidiasis.

Note: Thymopentin is a small part -- five amino acids -- of a
hormone produced by the thymus gland. Previous trials have
suggested that thymopentin is safe; but the drug, perhaps
erroneously, developed a community reputation as not being
very effective.

However, a trial in over 350 asymptomatic patients suggested
that TP-5 might significantly slow disease progression
[reported at the International Conference on AIDS, Berlin,
July 6-11, 1993, poster #2144]. When comparing progression to
ARC, AIDS, or death, it found only 2.7 such events per 100
person-years for patients taking AZT plus thymopentin,
compared to 10.4 events for those taking AZT alone. When
comparing progression to AIDS or death only (not including
ARC, an obsolete concept which can be difficult to interpret
consistently), for those patients with T-helper counts
between 200 and 400, it found only one event in the
thymopentin plus AZT group, compared to eight events with AZT
alone. However, the total number of events was too small to
provide conclusive proof that thymopentin slows the
progression of HIV disease, and the FDA insisted on a
followup trial to confirm the result, before the drug could
be approved.

The trial sites are in the following cities: Atlanta, GA;
Austin, TX; Beverly Hills, CA; Bronx, NY; Brookline, MA;
Chicago, IL (2 sites); Cleveland, OH; Coral Gables, FL;
Dallas, TX; Ft. Lauderdale, FL; Greenwich, CT; Hampton, VA;
Houston, TX; Indianapolis, IN; Kansas City, MO; Kirkland, WA;
Miami Beach, FL; Milwaukee, WI; New Orleans, LA; New York, NY
(4 sites); Philadelphia, PA (2 sites); Pittsburgh, PA;
Redwood City, CA; San Diego, CA; San Francisco, CA (2 sites);
San Juan, PR; Sherman Oaks, CA; St. Louis, MO; Stony Brook,
NY; Sylmar, CA; Tampa, FL; Torrance, CA; Washington, DC; and
Wichita, KS.

For more information, including a contact person and phone
number in a city convenient for you, call the AIDS Clinical
Trials Information Service, 800/TRIALS-A.

[Note 2: A separate trial, at only three sites (Tarzana,
Pittsburgh, and San Francisco), is studying the effect of
thymopentin on viral load and on lymphoproliferative
responses. Volunteers can have any T-helper count under 400;
they must be either asymptomatic or minimally symptomatic.
More information about this trial is also available through
800/TRIALS-A.]




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