- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00001012
A Study of AL721 in HIV-Infected Patients With Swollen Lymph Nodes
An Open Label, Multiple Dose Ranging Trial of AL721 in Patients With Persistent Generalized Lymphadenopathy and Symptomatic HIV Infection
Study Overview
Detailed Description
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.
Study Type
Enrollment
Phase
- Phase 1
Contacts and Locations
Study Locations
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California
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Los Angeles, California, United States, 90033
- Los Angeles County - USC Med Ctr
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Louisiana
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New Orleans, Louisiana, United States, 70112
- Louisiana State Univ Med Ctr / Tulane Med School
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New Orleans, Louisiana, United States, 70112
- Tulane Univ School of Medicine
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New Orleans, Louisiana, United States, 70112
- Charity Hosp / Tulane Univ Med School
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Minnesota
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Minneapolis, Minnesota, United States, 55455
- Univ of Minnesota
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New York
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Bronx, New York, United States, 10468
- Bronx Veterans Administration / Mount Sinai Hosp
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New York, New York, United States, 10003
- Beth Israel Med Ctr / Peter Krueger Clinic
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New York, New York, United States, 10021
- Mem Sloan - Kettering Cancer Ctr
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New York, New York, United States, 10029
- Mount Sinai Med Ctr
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria
- Persistent generalized lymphadenopathy (PGL) (CDC-Group III), defined as palpable lymphadenopathy (nodes of 1 cm or greater) at two or more noncontiguous extrainguinal sites persisting for > 3 months in the absence of an illness other than HIV infection to account for the findings.
- AIDS related complex (ARC), defined as the presence of at least one of the following findings within 12 months prior to entry and the absence of a concurrent illness or condition other than HIV infection to explain the findings:
- Any findings which define CDC-Group IV A.
- History of any one of the findings that define CDC-Group IV C2.
- Patients with any of the ARC symptoms can also have PGL and be enrolled in the protocol as ARC patients.
- A positive antibody to HIV by any federally licensed ELISA test kit within 30 days of entry.
Concurrent Medication: Allowed:
- Topical or oral antifungal, antiviral, or antibiotic agents to treat oral candidiasis, herpes simplex, herpes zoster, or bacterial infections that develop during the course of the study.
Exclusion Criteria
- Exclude hemophiliacs.
- Active substance abuse.
- Alcohol consumption should be kept to a minimum.
Co-existing Condition:
Patients with the following will be excluded:
- Hemophilia.
- History or presence of an AIDS-defining opportunistic infection or malignancy.
- AIDS related complex (ARC) patients with prior (within the last 12 months) or current history of diarrhea defined as = or > 3 liquid stools per day persisting for longer than 1 month.
- Significant malabsorption:
- Greater than 10 percent weight loss within past 3 months with serum carotene < 75 IU/ml or vitamin A < 75 IU/ml.
- Significant cardiac, liver, renal, or neurologic disorder.
- Active ARC-defining secondary infection (oral candidiasis, oral hairy leukoplakia, multidermatomal herpes zoster, recurrent nontyphoidal Salmonella bacteremia or Nocardiosis) undergoing therapy or prophylaxis within 7 days of study entry.
- Active tuberculosis under treatment.
- Concurrent neoplasm other than basal cell carcinoma of the skin or in situ carcinoma of the cervix.
Concurrent Medication:
Excluded:
- Any medication that will interfere with the assessment of AL-721, including nutritional supplements, vitamins, laxatives, and over-the-counter products containing lecithin.
- Chemoprophylaxis for Pneumocystis carinii (PCP), candida, herpes simplex, herpes zoster infections, or bacterial infections.
- Intravenous topical or oral antifungal, antiviral, or antibiotic agents to treat oral candidiasis, herpes simplex, herpes zoster, or bacterial infections that develop during the course of the study.
- Systemic chemotherapy.
Prior Medication:
Excluded within 30 days of study entry:
- Any investigational drug.
- Biologic response modifiers.
- Corticosteroids.
- Chemotherapeutic agents.
- Excluded within 90 days of study entry:
- Any antiretroviral agent or AL-721.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Masking: None (Open Label)
Collaborators and Investigators
Investigators
- Study Chair: Armstrong D
- Study Chair: Mildvan D
Publications and helpful links
General Publications
- 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 (1988). 1991;4(10):945-51.
Study record dates
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- RNA Virus Infections
- Virus Diseases
- Blood-Borne Infections
- Communicable Diseases
- Sexually Transmitted Diseases, Viral
- Sexually Transmitted Diseases
- Lentivirus Infections
- Retroviridae Infections
- Immunologic Deficiency Syndromes
- Immune System Diseases
- Slow Virus Diseases
- HIV Infections
- Infections
- Acquired Immunodeficiency Syndrome
Other Study ID Numbers
- ACTG 022
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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