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

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)

Criteria

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.