Peptide T: Major Study Recruiting in Los Angeles

A controlled trial of peptide T, an experimental treatment which some researchers believe may be helpful in treating neurological effects sometimes caused by AIDS, is now seeking at least 150 volunteers. This one-year trial, jointly sponsored by the U. S. National Institute of Mental Health and the U. S. National Institute of Allergy and Infectious Diseases, will be run at a single site, the University of Southern California School of Medicine, Los Angeles County USC Medical Center. (For background about peptide T, see below.)

For the first six months on the trial, half of the patients will receive a placebo; the others, peptide T. But during the final six months there will be no placebo, so everyone will receive the drug. Peptide T will be taken by nasal spray; the dose will be 2 mg three times a day.

Volunteers will be allowed to use any FDA-approved medications for prevention or treatment of opportunistic infections, and they may also continue treatment with AZT or other antivirals if they are taking them when they begin the study. Also, it is OK to start a new antiviral treatment after the first six months. So that accurate data will be collected, it is important that volunteers not use recreational drugs, sleeping pills, or tranquilizers during the study, and refrain from alcohol for 48 hours prior to the monthly appointments for tests. And volunteers must not have taken drug treatment for a psychiatric problem within four weeks of starting the study, or have taken Prozac (a longer-lasting tranquilizer) within eight weeks.

Because this study will look mainly for neurological and cognitive improvements, it is seeking volunteers who are HIV positive and have problems with concentration or memory (for example, frequently losing keys or wallets, or forgetting why one came into a room). Yet these symptoms must not be too severe, because volunteers must be able to complete a battery of neurocognitive tests (tests of mental functioning) in order to enter the study, and these tests can be somewhat difficult for anyone.

Participants may have any T-helper count. They need to have enough fluency in English to take the neurocognitive tests used in the study.

Exclusion criteria include frequent need for hospitalization or other serious underlying medical problems, more than 10 KS lesions, pregnancy, or current use of cocaine, heroin, or marijuana. There are various scientific reasons for these exclusions. For example, a person with serious KS will be likely to need chemotherapy before the study ends, and chemotherapy can affect performance on the tests used in this trial, and therefore affect the data and the study results.

Each participant will require tests on three days at entry to the study. No hospitalization or overnight stay will be required; however, it is possible to stay overnight at the medical center, for persons from outside the area who want to avoid the cost of a hotel. Later, monthly visits (each requiring about two and a half hours at the clinic) will continue for 12 months. Two lumbar punctures will be required -- one at entry to the study, and the other at six months. (Special very fine needles are used, to reduce the possibility of post-tap headache.) And tests of the cerebrospinal fluid -- for syphilis, cryptococcal meningitis, and toxoplasmosis -- provide the participant with valuable diagnostic information. The six-month appointment will also include a skin test, which takes 48 hours before it can be read; therefore two visits, 48 hours apart, will be required at that time.

Volunteers need not live in the Los Angeles area; however, the study is not able to pay for their transportation. It is important that those entering the study be able to stay with it for the one-year period.

If this trial shows that peptide T is effective, then "best effort" will be made to obtain it for the volunteers after the study is over, until the drug is commercially available. However, no guarantees of access after the trial can be given.

For more information about volunteering for this new trial, call Bob Herr, at the University of Southern California Medical Center, 213/226-4643.

Background

Peptide T has been controversial for years, but there has long been consensus among knowledgeable researchers that the drug appears safe. Originally it had been hoped that it would have an antiviral effect by preventing attachment of virus to cells, much like soluble CD4 was supposed to do. But (as with soluble CD4) little or no antiviral effect was found. This disappointment decreased interest in the drug among researchers and in the AIDS community overall.

But though the drug did not appear to work directly as an antiviral, many people who used it reported lessening of HIV- related symptoms. And two small phase I studies found notable improvements in neurocognitive test performance, and also in constitutional symptoms (for example, weight gain and reduced fatigue) in persons using peptide T. Because these trials were small, and because they had no control group to allow direct comparison between those using and not using peptide T, a larger, controlled study is needed to confirm or disprove their results. That is what the new phase II trial is designed to do. It is intended to be a pivotal study of peptide T -- one that could lead to drug approval -- in terms of neurocognitive endpoints.

Meanwhile, struggles continue to make peptide T accessible to persons not in the trial who believe that the treatment is important to them. An expanded access program, such as one for ddI or ddC, certainly seems appropriate, especially for persons with the neurocognitive symptoms for which peptide T seems to have worked in the past. The most serious roadblock to such a program is money, as no large pharmaceutical company is currently developing peptide T; the two small companies most closely involved could not fund a major program to provide the drug.

At a crucial meeting on peptide T at the National Institute of Mental Health on March 8 of this year, agreements were reached to continue providing access to participants in the phase I trial now administered by the Community Research Initiative of New England. However, this agreement does not cover participants in another phase I trial, at the University of Southern California in Los Angeles. ACT UP/Los Angeles is currently working to negotiate such an arrangement; and they are trying to locate all the participants in that trial. If you were in the earlier Los Angeles trial of peptide T and are not already in touch with ACT UP/Los Angeles, call them at the number below. [Note: The principal investigator of the new phase II study, Peter Heseltine, M. D., has arranged for participants in the old trial to be included in the new one. Persons who were in the phase I trial should call Bob Herr at the number above if they are interested in entering the new study.]

In November 1990 it became more difficult than in the past to buy peptide T in the United States, due to its changed legal status when the FDA selected a manufacturer, Carlbiotech, to provide the drug for the phase II trial now starting. An arrangement was set up to grant case-by-case permission to purchase the drug for personal use, and on March 8, the first such permission was granted. We do not know whether or not this system will in practice be feasible for others.

For information about how you can help in activist efforts concerning peptide T, you could contact any of the following people or organizations (partial list):

* The Provincetown Positive PWA Coalition, 508/487-3998; ask for John Perry Ryan.

* ACT UP/Provincetown, 508-487-2063.

* ACT UP/Los Angeles 213/669-7301; or call Jim Jensen, 213/465-4549.

* Anna Blume, c/o Alternative and Holistic Treatment Committee, 135 W. 29th St. #10, New York, NY 10001.

* ACT UP/Boston: call Rolf Erikson, 617/899-5847.

* Fred Nunley, message at ACT UP/DC, 202/728-7530.

For more information on peptide T, see AIDS TREATMENT NEWS #22 (January 16, 1987), #34 (June 19, 1987), #84 (July 28, 1989), and #119 (January 18, 1991). Note that our coverage has only outlined parts of the complex, extensive, and controversial story of this drug. Books could be, and will be, written about the history of peptide T.