An Open Label, Multiple Dose Ranging Trial of AL721 in Patients With Persistent Generalized Lymphadenopathy and Symptomatic HIV Infection
Although zidovudine (AZT) prolongs life in certain AIDS patients, it is not a cure for AIDS
and it also has toxic effects in many patients. Therefore, it is necessary to test other
drugs in HIV-infected patients. AL-721 is a mixture of lipids (fats) extracted from egg
yolks. Laboratory tests suggest that it might inhibit the infectivity of the HIV. AL-721 has
been tried so far in a few patients for short periods of time and has been found to be well
tolerated.
Patients receive AL-721 twice daily. The first dose is taken on an empty stomach 1 hour
before a fat-free breakfast, with specific instructions given on foods that are allowed; the
second dose is taken at least 3 hours after the evening meal. No snacks are permitted after
the evening meal or after the evening dose of study medication. The study is scheduled to
last for 16 weeks of treatment and 4 weeks of follow-up. Throughout the study, frequent
blood samples will be taken from an arm vein. The blood samples are studied to evaluate any
changes in the patient's immune system, any toxic effects that might be detected in the
blood, and any changes in the presence of the HIV in the blood.
Interventional
Masking: Open Label, Primary Purpose: Treatment
Mildvan D
Study Chair
United States: Federal Government
ACTG 022
NCT00001012
Name | Location |
---|---|
Mem Sloan - Kettering Cancer Ctr | New York, New York 10021 |
Los Angeles County - USC Med Ctr | Los Angeles, California 90033 |
Louisiana State Univ Med Ctr / Tulane Med School | New Orleans, Louisiana 70112 |
Tulane Univ School of Medicine | New Orleans, Louisiana 70112 |
Univ of Minnesota | Minneapolis, Minnesota 55455 |
Bronx Veterans Administration / Mount Sinai Hosp | Bronx, New York 10468 |
Mount Sinai Med Ctr | New York, New York 10029 |
Beth Israel Med Ctr / Peter Krueger Clinic | New York, New York 10003 |
Charity Hosp / Tulane Univ Med School | New Orleans, Louisiana 70112 |