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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.

Sponsored by: 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

MedlinePlus related topics:   AIDS   

Drug Information available for:   Zidovudine    Didanosine    Stavudine    Zalcitabine    Thymopentin   

U.S. FDA Resources

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
  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

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Sponsors and Collaborators
Immunobiology Research Institute
  More Information


Study ID Numbers:   015H, 07.32.033-93
First Received:   November 2, 1999
Last Updated:   June 23, 2005
ClinicalTrials.gov Identifier:   NCT00002109
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

Study placed in the following topic categories:
Virus Diseases
Sexually Transmitted Diseases, Viral
Stavudine
Didanosine
HIV Infections
Thymopentin
Zalcitabine
Sexually Transmitted Diseases
Acquired Immunodeficiency Syndrome
Zidovudine
Retroviridae Infections
Immunologic Deficiency Syndromes

Additional relevant MeSH terms:
Antimetabolites
Anti-Infective Agents
RNA Virus Infections
Anti-HIV Agents
Slow Virus Diseases
Immunologic Factors
Immune System Diseases
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Adjuvants, Immunologic
Enzyme Inhibitors
Infection
Antiviral Agents
Pharmacologic Actions
Reverse Transcriptase Inhibitors
Anti-Retroviral Agents
Therapeutic Uses
Lentivirus Infections
Nucleic Acid Synthesis Inhibitors

ClinicalTrials.gov processed this record on December 03, 2008




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