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

Inclusion 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.