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| Sponsored by: |
National Institute of Allergy and Infectious Diseases (NIAID) |
| Information provided by: | National Institute of Allergy and Infectious Diseases (NIAID) |
| ClinicalTrials.gov Identifier: | NCT00001012 |
Purpose
To study the tolerance and safety of increasing doses of AL-721 in patients with persistent generalized lymphadenopathy (PGL) and symptomatic HIV infection, and to obtain preliminary information on the effectiveness of AL-721 against the human immunodeficiency virus (HIV) in HIV-infected persons with PGL 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.
| Condition | Intervention | Phase |
|
HIV Infections |
Drug: AL 721 |
Phase I |
| MedlinePlus related topics: | AIDS |
| Drug Information available for: | AL 721 |
| Study Type: | Interventional |
| Study Design: | Treatment, Open Label |
| Official Title: | An Open Label, Multiple Dose Ranging Trial of AL721 in Patients With Persistent Generalized Lymphadenopathy and Symptomatic HIV Infection |
| Estimated Enrollment: | 50 |
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.
Eligibility
| Ages Eligible for Study: | 18 Years to 60 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria
Concurrent Medication: Allowed:
Exclusion Criteria
Co-existing Condition:
Patients with the following will be excluded:
Concurrent Medication:
Excluded:
Prior Medication:
Excluded within 30 days of study entry:
Contacts and Locations| United States, California | |||||
| Los Angeles County - USC Med Ctr | |||||
| Los Angeles, California, United States, 90033 | |||||
| United States, Louisiana | |||||
| Charity Hosp / Tulane Univ Med School | |||||
| New Orleans, Louisiana, United States, 70112 | |||||
| Louisiana State Univ Med Ctr / Tulane Med School | |||||
| New Orleans, Louisiana, United States, 70112 | |||||
| Tulane Univ School of Medicine | |||||
| New Orleans, Louisiana, United States, 70112 | |||||
| United States, Minnesota | |||||
| Univ of Minnesota | |||||
| Minneapolis, Minnesota, United States, 55455 | |||||
| United States, New York | |||||
| Mem Sloan - Kettering Cancer Ctr | |||||
| New York, New York, United States, 10021 | |||||
| Mount Sinai Med Ctr | |||||
| New York, New York, United States, 10029 | |||||
| Bronx Veterans Administration / Mount Sinai Hosp | |||||
| Bronx, New York, United States, 10468 | |||||
| Beth Israel Med Ctr / Peter Krueger Clinic | |||||
| New York, New York, United States, 10003 | |||||
| Study Chair: | Mildvan D | |
| Study Chair: | Armstrong D |
More Information
|
Mildvan D, Armstrong D, Antoniskis D, Sacks H, Balfour H, Buzas J, Pettinelli C. An open label dose-ranging trial of al721 in pgl and ARC. Int Conf AIDS. 1989 Jun 4-9;5:403 (abstract no WBP312)
  |
|
Mildvan D, Buzas J, Armstrong D, Antoniskis D, Sacks HS, Rhame FS, Mosbach EW, Pettinelli C. An open-label, dose-ranging trial of AL 721 in patients with persistent generalized lymphadenopathy and AIDS-related complex. J Acquir Immune Defic Syndr. 1991;4(10):945-51.
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| Study ID Numbers: | ACTG 022 |
| First Received: | November 2, 1999 |
| Last Updated: | June 23, 2005 |
| ClinicalTrials.gov Identifier: | NCT00001012 |
| Health Authority: | United States: Federal Government |
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