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AIDS Treatment News
ICC Trials -- First Study Enrolling
John S. James
March 24, 1995
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 taken AZT.

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 series.

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, 813/753-2949.

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 Carson, 612/927-1381.

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, 212/420-4519.

Detroit, MI; Dr. Louis Saravolatz, 313/876-2573.

Denver, CO; Dr. Robert Schooley, 303/270-6753.

Atlanta, GA; Dr. Melanie Thompson, 404/876-2317.