AIDS TREATMENT NEWS #219, March 24, 1995
The first of a series of trials of the Inter-Company
Collaboration for AIDS Drug Development (ICC) is now
enrolling. These trials are particularly important for at
least two reasons:
(1) The ICC is an association of 15 pharmaceutical companies
set up to share information and otherwise facilitate the
testing of drug combinations -- which otherwise can be
difficult when the drugs are produced by different
companies. This cooperation allows rational combination
treatments to be rapidly designed and tested.
(2) The choice of combinations to test is based on analysis
of all available information about the drugs --
laboratory tests, virological analysis, and human
experience; some of this information is proprietary and
has not been released publicly outside the ICC.
Therefore, the combinations chosen from this analysis may
be worth considering even for treatment outside the
trials, when the drugs are available.
The study now enrolling is seeking volunteers with CD4 (T-
helper) counts between 200 and 500, who have NOT previously
The current series of planned ICC trials has a master-
protocol design, meaning that the different trials in this
series will differ little, except for the choice of drugs.
Each trial will last 48 weeks. It will randomly assign 75
volunteers each to three different treatment arms. Everyone
in the trial will receive the same combination of two drugs;
but one treatment group will receive a third drug in
addition, another treatment group will receive a different
third drug, and the third treatment group will receive a
placebo for the third drug (meaning that they will be treated
with the basic two-drug combination).
These trials will look for changes in blood tests, especially
viral load and CD4 count. They will not look for differences
in clinical endpoints, since few opportunistic infections
would be expected to occur in these trials.
In the first trial, ICC 001, which is now enrolling patients,
the two drugs that everyone will receive are AZT (brand name
Retrovir) and ddC (brand name HIVID). As the third drug, one
group will receive nevirapine (an experimental non-nucleoside
reverse-transcriptase inhibitor). Another group will receive
saquinavir (brand name Invirase, the Hoffmann-La Roche
protease inhibitor) as its third drug. The third treatment
group, with the placebo third drug, will be receiving AZT
plus ddC, which might be more beneficial for those who have
not taken AZT before than for those who have.
Future ICC Plans
After the first trial is fully enrolled, volunteers will be
enrolled into the second trial, ICC 002. In this trial, the
two drugs everyone will receive will be AZT and ddI. One
group will receive nevirapine as the third drug; another
group will receive 3TC as the third drug.
We do not know what combinations will be tested later in this
In addition to this series of trials, the ICC may also
conduct other trials with a different design. Some of these
future trials may have fewer patients and may run for less
than 48 weeks -- since changes in blood work are likely to be
seen quickly, and changes in clinical outcome will not be
seen in any case in these studies.
For Information on How to Enroll
The first trial (ICC 001) is being conducted in the cities
listed below. For more information, you can call the
coordinating center at PAREXEL International Corporation,
800/925-AIDS, from 9 a.m. to 5 p.m. Eastern time. Or you can
call directly to the office of the physician in your city.
Bradenton, FL; Dr. Michael Bach or Dr. Jeffrey Nadler,
Milwaukee, WI; Dr. Barry Bernstein, 414/257-6151.
Sherman Oaks, CA; Dr. Paul Berry, 818/906-6279.
Torrance, CA; Dr. Gildon Beall, 310/222-2365; call the study
coordinator Sally Kruger, 310/222-3848.
Maitland, FL; Dr. Jeffrey Goodgame, 407/647-6000.
St. Paul, MN; Dr. Keith Henry, 612/221-1280, or Dr. Paul
Ft. Lauderdale, FL; Dr. Anthony La Marca, 305/564-4222.
San Francisco, CA; Dr. William Lang, 415/474-4440.
New York, NY; Dr. Donna Mildvan; call Clinical Trials Unit,
Detroit, MI; Dr. Louis Saravolatz, 313/876-2573.
Denver, CO; Dr. Robert Schooley, 303/270-6753.
Atlanta, GA; Dr. Melanie Thompson, 404/876-2317.