Adefovir Dipivoxil Trials: CD4 100-500, Protease Inhibitor Naive
Two trials of adefovir dipivoxil in combination with other antiretroviral treatments are recruiting in cities throughout the U.S. This drug, taken once a day, has shown modest activity against HIV, and also is known to be active against CMV, hepatitis B, HHV6, and Epstein-Barr virus. Adefovir is believed to be active in macrophages as well as lymphocytes, and to be active against viruses which have become resistant to other drugs. It is important to complete these trials so that if this drug proves helpful in combination treatment of HIV, it can be approved and used.Both studies last 48 weeks. Since the viral load tests will be analyzed in batches, patients will receive their viral load results after weeks 8, 20, 32, and 48. All of the drugs and tests are free.
Study GS-96/411 -- Antiretroviral Naive
This trial is recruiting 100 volunteers who are antiretroviral naive. They will be assigned to one of five groups, all of which include the Merck protease inhibitor indinavir (CrixivanŽ):
adefovir + indinavir + AZT + 3TC
adefovir + indinavir + AZT
adefovir + indinavir + 3TC
adefovir + indinavir + d4T
indinavir + AZT + 3TC
This trial is running in: Baltimore; Boston; Chicago; Dallas; Greenwich, CT; Hershey, PA; Long Island, NY; Los Angeles; New York (2 sites); Phoenix; Ponce, PR; Providence, RI; San Francisco; Seattle; and Washington, DC.
Study GS-97/417 --
Protease Inhibitor Naive
This study is seeking 120 patients who have never taken protease inhibitors, but have taken approved nucleoside analog antiretrovirals for at least four weeks. They will be randomly assigned to either:
adefovir + nelfinavir + saquinavir soft gel
adefovir + nelfinavir + nucleoside analog treatment
adefovir + saquinavir soft gel + nucleoside analog treatment
The nucleoside analog treatment will be chosen to try to give the patients new drugs, when possible.
This trial is running in: Atlanta; Baltimore; Boston; Chicago; Dallas; Greenwich, CT; Long Island, NY; Los Angeles (3 sites); Miami; New York City; Philadelphia; Phoenix; Ponce, PR; Providence, RI; San Francisco; Santurce, PR; Seattle; Tulsa; Washington, DC; and Worchester, MA.
For More Information
Patients or their physicians can contact Gilead Sciences Medical Information Department, 800/GILEAD-5 (press 3) from 8:30 a.m. to 5:00 p.m. Pacific time.
Or 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; but note that 800/TRIALS-A lists these trials as FDA 232D and FDA 232E, respectively.
