Double-Blind Study of Timunox (Thymopentin) in Asymptomatic HIV-Infected Patients Receiving Either Mono (AZT or ddI) or Combination (AZT / ddI or AZT / ddC) Anti-Retroviral Therapy
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Keep this study
Lead
Immunobiology Research Institute
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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.
You may not be if
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.
Clareo Health | Double-Blind Study of Timunox (Thymopentin) in Asymptomatic HIV-Infected Patients Receiving Either Mono (AZT or ddI) or Combination (AZT / ddI or AZT / ddC) Anti-Retroviral Therapy
