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

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

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 ).

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Immunobiology Research Institute
• Treatments: Didanosine; Stavudine; Thymopentin; Zalcitabine; Zidovudine

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.