An Open Label, Multiple Dose Ranging Trial of AL721 in Patients With Persistent Generalized Lymphadenopathy and Symptomatic HIV Infection

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.

History of severe allergic reactions to study medication Currently pregnant or breastfeeding Recent participation in another clinical trial within the last 30 days Presence of uncontrolled medical conditions that could affect safety