Clinical Drug Experience Knowledgebase

Criteria

Inclusion Criteria

Patients must have:

Asymptomatic HIV infection.
CD4 count 100-400 cells/mm3.
No HIV-associated neurologic abnormalities or constitutional symptoms.
No oral hairy leukoplakia.
At least 6 months of prior AZT.

Exclusion Criteria

Co-existing Condition:

Patients with the following symptoms or conditions are excluded:

Abnormal chest x-ray, consistent with active opportunistic infection.
Hypersensitivity to thymopentin.
Significant chronic underlying medical illness.
Grade 2 or worse peripheral neuropathy.

Concurrent Medication:

Excluded:

HIV vaccines.
Investigational or non-FDA approved medication.
Immunomodulatory therapies.
Experimental therapies.
Any antiretroviral therapy other than AZT, ddI, ddC, d4T, or 3TC.

Patients with the following prior conditions are excluded:

Herpes zoster (within the past year).
Recurrent (> one episode) oral candidiasis (confirmed).
Vulvovaginal candidiasis (persistent, frequent, or poorly responsive to therapy).
Bacillary angiomatosis.
Listeriosis.
Idiopathic thrombocytopenia purpura.

Prior Medication:

Excluded at any time prior to study entry:

More than one dose of thymopentin.

Excluded within 30 days prior to study entry:

HIV vaccines.
Investigational or non-FDA approved medication.
Immunomodulatory therapies.
Experimental therapies.
Any antiretroviral therapy other than AZT, ddI, ddC, d4T, or 3TC.

Required:

Prior AZT (>= 300 mg/day) for at least 6 months; on current regimen (any combination of approved nucleoside analogues) for at least 4 weeks.

Significant active alcohol or drug abuse.