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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

I

Immunobiology Research Institute

Status and phase

Completed
Phase 3

Conditions

HIV Infections

Treatments

Drug: Stavudine
Drug: Didanosine
Drug: Zidovudine
Drug: Thymopentin
Drug: Zalcitabine

Study type

Interventional

Funder types

Industry

Identifiers

NCT00002109
015H
07.32.033-93

Details and patient eligibility

About

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 ).

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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.

Trial contacts and locations

50

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Data sourced from clinicaltrials.gov

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