A Study of AL721 in HIV-Infected Patients With Swollen Lymph Nodes

Completed · Phase 1

Conditions studied: HIV Infections

In brief

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.

Key facts

Study ID

NCT00001012

Run by

National Institute of Allergy and Infectious Diseases (NIAID)

People needed

50

Last updated by the study team

2021-11-01

Who can join

Age: 18 and older, up to 60. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Los Angeles County - USC Med Ctr — Los Angeles, California, United States
• Charity Hosp / Tulane Univ Med School — New Orleans, Louisiana, United States
• Louisiana State Univ Med Ctr / Tulane Med School — New Orleans, Louisiana, United States
• Tulane Univ School of Medicine — New Orleans, Louisiana, United States
• Univ of Minnesota — Minneapolis, Minnesota, United States
• Beth Israel Med Ctr / Peter Krueger Clinic — New York, New York, United States
• Mem Sloan - Kettering Cancer Ctr — New York, New York, United States
• Mount Sinai Med Ctr — New York, New York, United States
• Bronx Veterans Administration / Mount Sinai Hosp — The Bronx, New York, United States

Full record on ClinicalTrials.gov

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