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

Study Overview
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Brief Summary
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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 ).

Official Title
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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

Conditions
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HIV Infections

Intervention / Treatment
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* Drug: Thymopentin
* Drug: Stavudine
* Drug: Zidovudine
* Drug: Zalcitabine
* Drug: Didanosine


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Thymopentin|nan|
|Drug: Stavudine|nan|
|Drug: Zidovudine|nan|
|Drug: Zalcitabine|nan|
|Drug: Didanosine|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Thymopentin, Zalcitabine, Didanosine, Drug Therapy, Combination, Zidovudine, Stavudine