1592: Two Studies Recruiting

1592U89, usually called 1592, is an experimental nucleoside analog drug (in the same class as AZT) with much community interest, for several reasons. First, research has shown that under some conditions at least, it can produce a 2-log (100 fold) viral reduction with just one drug. Also, it has good penetration of the blood-brain barrier, suggesting potential use for treating AIDS-related dementia. And a third reason for the intense interest is that 1592 is a new possible treatment for persons who do not have other options.

[Note: On November 12 THE WALL STREET JOURNAL published a major article on 1592, "Why Isn't Glaxo's New AIDS Drug Ready Yet," by Michael Waldholz, page B1; it asks why 1592 has been in research much longer than other new AIDS drugs but is not expected to be marketed until almost two years from now, and is not being made available through expanded access for those with no other treatment options. Activists suspect that the drug is being delayed to avoid competing with AZT and 3TC; Glaxo says it did not know until about a year ago how much more powerful this drug is than others. It is remarkable how Glaxo's arguments against expanded access resurrect those that were used years ago against other AIDS drugs, and long ago abandoned.]

Glaxo Wellcome is now running two preliminary trials of 1592:

Protocol 2003

This trial will test the antiretroviral activity of 1592 in 40 persons nationally who are already using certain approved nucleoside analog drugs. Forty persons will be enrolled in this study, and all will receive the same dose of 1592 (300 mg orally twice a day), in combination with other nucleoside analogs. There is no placebo. In order to enter this study, volunteers must be at least 13 years old, must have a CD4 count of at least 100, and must have a viral load of at least 30,000.

But there are complex entry criteria based on pre-existing antiretroviral therapy; for example, anyone who has used a protease inhibitor, or a non-nucleoside reverse transcriptase inhibitor (e.g. nevirapine) is ineligible. In order to enter this study, a person must fit in at least one of the four following categories:

* At least 12 months of AZT monotherapy;

* At least 6 months of 3TC and 12 months of AZT;

* At least 6 months of ddI monotherapy;

* At least 6 months of d4T and 12 months of AZT.

Anyone who has had other antiretroviral treatments is not eligible for this trial.

The trial is being run in eight cities; we list the state, city, study coordinator, institution, and phone number at each site. For more information, call the contact person listed:

* California: Greenbrae (Alison Clayton, Marin County Specialty Clinic, 415/499-7377);

* California: Los Angeles (Scott Brooks, Kraus Medical Partners, 213/930-2324);

* California: San Francisco (Debbie Hildebrandt, ViRx, Inc., 415/353-5623 or 415/474-4440);

* Florida: Ft. Lauderdale (Keith Huber, R.N., North Broward Hospital District, 954/467-3006 ext. 240);

* Florida: Maitland (Neena Griffin, R.N., Central Florida Research Initiative, 800/868-3483 ext. 3, or 407/647-3960);

* Georgia: Atlanta (Laura Ray, AIDS Research Consortium of Atlanta, 404/876-2317 ext. 329);

* Kentucky: Lexington (Karen Meekins, R.N., University of Kentucky Medical Center, 606/323-3933);

* New York: New York (Ann Marshak, Beth Israel Medical Center, 212/420-4519).

Protocol CNAB3001

This is a 90-patient phase III study for persons with HIV-associated dementia. Volunteers will be able to continue their current antiretroviral treatment in most cases, and will be randomized to receive 1592 or placebo for 12 weeks. After the 12 weeks, all participants will receive 1592 for 40 weeks. The dose of 1592 used in this study is 600 mg twice a day.

To be eligible, persons must be between 18 and 65 years old, and must have been stable on their current antiretroviral treatment for at least six weeks. There are a number of exclusion conditions, especially for certain abnormal laboratory tests, or for certain unrelated illnesses.

For more information, call the contact person at a site which you could attend:

Baltimore (Tish Nance, 410/955-7464);

Chapel Hill (Wendy Robertson, 919/966-6727);

New York - Columbia University (Ronda Freedman-Clouse, R.N. 212/960-2230);

New York - Mt. Sinai (Jessica Moise, 212/241-0784);

San Diego - (Mary Anne or Mary McCarthy or Dr. Stephen Brown, 619/543-5059);

San Francisco (Dr. Richard Price, 415/206-3208);

St. Louis (Meridith Glicksman, 314/362-9733).