HIV Infections
Conditions
Keywords
Thymopentin, Zalcitabine, Didanosine, Drug Therapy, Combination, Zidovudine, Stavudine
Brief summary
To confirm results from a previous study in which the combination of thymopentin plus zidovudine ( AZT ), an antiretroviral agent, slowed disease progression in HIV-infected asymptomatic patients. To evaluate the efficacy and safety of thymopentin in HIV-infected asymptomatic patients receiving either monotherapy with AZT, didanosine ( ddI ), or stavudine ( d4T ), or combination antiretroviral therapy with AZT / ddI or AZT / zalcitabine ( ddC ).
Interventions
Sponsors
Immunobiology Research Institute
Study design
Primary purpose
TREATMENT
Masking
DOUBLE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Countries
Puerto Rico, United States
Outcome results
None listed