DMP 266 Trials Recruiting, Many Cities -- Protease Inhibitor Naive

DMP 266, an important antiretroviral now in clinical trials, is an NNRTI (non-nucleoside reverse transcriptase inhibitor, in the same general class as the approved drugs nevirapine or delavirdine). But it is a new kind of NNRTI, and unlike the others in that HIV drug resistance seems to develop much more slowly (although it does occur). So far we have heard good anecdotal reports about this drug.

Other potential advantages of DMP 266, which is being developed by DuPont Merck Pharmaceutical Company of Wilmington, Delaware, are (1) this drug is taken once a day, which should make adherence easier, and (2) so far there do not seem to be the serious supply problems which have occurred with Glaxo Wellcome's 1592 and some other antiretrovirals.

Two phase III trials of DMP 266 are now recruiting. Unfortunately both are open only to persons who have never used protease inhibitors. Both studies last 24 weeks, but the company is providing the drug to volunteers who complete either trial and want to continue.

DMP 266-020

This trial, in persons who are already taking nucleoside analog treatment, is comparing adding DMP 266 plus indinavir (Merck's CrixivanŽ), vs. only adding indinavir to the volunteer's ongoing regimen. This trial needs a total of 300 volunteers, and so far is about half filled.

The problem is the entry criteria. Volunteers must have taken some nucleoside analog treatment for at least eight weeks (within 12 weeks before being screened for this trial), but must never have taken any protease inhibitor, nor nevirapine nor delavirdine. They must be asymptomatic, with a CD4 count of at least 50, and a viral load of at least 10,000. Other entry restrictions include: no other experimental drugs for at least 30 days; no abnormal levels of serum creatinine, liver function tests, alkaline phosphatase, bilirubin, or serum amylase; and no below-normal levels of hemoglobin, platelets, or absolute neutrophil count.

Also, this trial does not pay for the nucleoside analog drugs which the volunteer was already on, which need to be continued for the 24 weeks of this study.

DMP 266-020 is now running in: Augusta, GA; Bradenton, FL; Buffalo; Calgary; Chicago (2 sites); Columbus, OH; Fall River, MA; Guaynabo, PR.; Hampton, VA; Lexington, KY; Los Angeles (2 sites); Manhassett, NY; Nashville; New Orleans; New York City (2 sites); Ottawa; Palm Springs, CA; Pittsburgh; Portland, OR; Rochester; Salt Lake City; San Antonio; San Francisco (2 sites); San Juan (3 sites); Seattle; Somerville, NJ; St. Louis; Tampa; and Washington, DC (2 sites).

DMP 266-006

This trial is almost full, having recruited about 400 of the 450 participants needed. It will probably be filled in the next several weeks. Volunteers are randomly assigned to one of three arms:

* DMP 266 plus indinavir;

* DMP 266 plus AZT plus 3TC; or

* Indinavir plus AZT plus 3TC.

All of these drugs will be paid for.

Volunteers must never have taken any protease inhibitor, nor nevirapine or delavirdine, nor 3TC. They must be asymptomatic or mildly symptomatic, with CD4 count at least 50 and viral load at least 10,000. They must not have taken any antiretroviral within 14 days. Other entry restrictions include: no other experimental drugs for at least 30 days; no abnormal levels of serum creatinine, liver function tests, bilirubin, or serum amylase; and no below-normal levels of hemoglobin, platelets, or absolute neutrophil count.

This study is running at sites in: Augusta, GA; Beverly Hills; Boulder; Charlotte; Chicago; Dallas; Frankfurt, Germany; Houston; Hove, Brighton, UK; Indianapolis; Irvine, CA; Kansas City; Lexington, KY; London, UK (2 sites); Los Angeles; Metairie, LA; Miami; New York City; Newark; Philadelphia; Providence, RI; San Antonio; San Diego; San Juan (2 sites); Seattle; Tampa; Toronto; Tucson; Washington, DC; and West Palm Beach, FL.

For more information, call the AIDS Clinical Trials Information Service, 800/TRIALS-A (TTY for the hearing impaired, 800/243-7012), 9 a.m. to 7 p.m. Eastern time, Monday through Friday; ask about DMP 266-020 or DMP 266-006. Or call the DuPont Merck HIV Clinical Trials Information System, 800/870-8899.