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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
This study has been completed.
First Received: November 2, 1999   Last Updated: June 23, 2005   History of Changes
Sponsor: Immunobiology Research Institute
Information provided by: NIH AIDS Clinical Trials Information Service
ClinicalTrials.gov Identifier: NCT00002109
  Purpose

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 ).


Condition Intervention Phase
HIV Infections
Drug: Thymopentin
Drug: Stavudine
Drug: Zidovudine
Drug: Zalcitabine
Drug: Didanosine
Phase III

Study Type: Interventional
Study Design: Treatment, Double-Blind, Safety Study
Official Title: 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

Resource links provided by NLM:

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00002109

  Show 50 Study Locations
Sponsors and Collaborators
Immunobiology Research Institute
  More Information

No publications provided

Study ID Numbers: 015H, 07.32.033-93
Study First Received: November 2, 1999
Last Updated: June 23, 2005
ClinicalTrials.gov Identifier: NCT00002109     History of Changes
Health Authority: United States: Food and Drug Administration

Keywords provided by NIH AIDS Clinical Trials Information Service:
Thymopentin
Zalcitabine
Didanosine
Drug Therapy, Combination
Zidovudine
Stavudine

Additional relevant MeSH terms:
Antimetabolites
Anti-Infective Agents
Sexually Transmitted Diseases, Viral
Slow Virus Diseases
Stavudine
Immunologic Factors
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Zidovudine
Infection
Reverse Transcriptase Inhibitors
Anti-Retroviral Agents
Therapeutic Uses
Thymopentin
Retroviridae Infections
Nucleic Acid Synthesis Inhibitors
RNA Virus Infections
Anti-HIV Agents
Immune System Diseases
Zalcitabine
Acquired Immunodeficiency Syndrome
Adjuvants, Immunologic
Enzyme Inhibitors
Antiviral Agents
Immunologic Deficiency Syndromes
Pharmacologic Actions
Virus Diseases
Didanosine
HIV Infections
Sexually Transmitted Diseases

ClinicalTrials.gov processed this record on November 09, 2009