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

June 23, 2005 updated by: Immunobiology Research Institute

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

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 ).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Puerto Rico
      • Rio Piedras, Puerto Rico, 00935
        • Univ of Puerto Rico Med Sciences Campus
      • San Juan, Puerto Rico, 00902
        • Initiativa Comunitaria de Investigacion
  • United States
    • Arizona
      • Phoenix, Arizona, United States, 85013
        • Fisher Med Group
    • California
      • Irvine, California, United States, 92718
        • Ctr for Special Immunology
      • Los Angeles, California, United States, 90036
        • Beer Med Group
      • Pasadena, California, United States, 90112
        • Gottlieb Med Group
      • Redwood City, California, United States, 94063
        • AIDS Community Research Consortium
      • San Diego, California, United States, 92102
        • HIV Research Group
      • San Francisco, California, United States, 94115
        • Conant Med Group
      • San Francisco, California, United States, 94115
        • Kaiser Permanente Med Ctr
      • Sherman Oaks, California, United States, 91403
        • Pacific Oaks Med Group
      • Torrance, California, United States, 90502
        • Harbor - UCLA Med Ctr
    • Connecticut
      • Greenwich, Connecticut, United States, 06830
        • Dr Gary Blick
    • District of Columbia
      • Washington, District of Columbia, United States, 20003
        • Dr Larry Bruni
      • Washington, District of Columbia, United States, 20037
        • Novum Inc
    • Florida
      • Coral Gables, Florida, United States, 33146
        • Community Research Initiative
      • Fort Lauderdale, Florida, United States, 33316
        • Ctr for Special Immunology
      • Fort Lauderdale, Florida, United States, 33334
        • Stratogen of Ft Lauderdale
      • Miami Beach, Florida, United States, 33140
        • Stratogen of South Florida
      • Tampa, Florida, United States, 33614
        • Saint Joseph's Hosp / Infectious Disease Rsch Institute
      • Tampa, Florida, United States, 33614
        • Infectious Disease Research Institute Inc
    • Georgia
      • Atlanta, Georgia, United States, 30327
        • West Paces Clinical Research Inc
    • Illinois
      • Chicago, Illinois, United States, 60612
        • Rush Presbyterian - Saint Luke's Med Ctr
      • Chicago, Illinois, United States, 60611
        • Northwestern Univ Med Ctr
      • Chicago, Illinois, United States, 60657
        • Ctr for Special Immunology
    • Indiana
      • Indianapolis, Indiana, United States, 46202
        • Infectious Diseases Research Clinic / Indiana Univ Hosp
    • Kansas
      • Wichita, Kansas, United States, 67214
        • Univ of Kansas School of Medicine
    • Massachusetts
      • Brookline, Massachusetts, United States, 02445
        • CRI of New England
    • Missouri
      • Kansas City, Missouri, United States, 641082792
        • Kansas City AIDS Research Consortium
      • St. Louis, Missouri, United States, 63108
        • Systemic Mycoses Pathogen Study Group / Wash Univ Sch of Med
    • New Mexico
      • Albuquerque, New Mexico, United States, 87108
        • Lovelace Scientific Resource
    • New York
      • Bronx, New York, United States, 10461
        • Van Etten Hosp / Bronx Municipal Hosp Ctr
      • New York, New York, United States, 10001
        • Dr David DiPietro
      • New York, New York, United States, 10010
        • Ctr for Special Immunology
      • New York, New York, United States, 10014
        • Dr Howard A Grossman
      • New York, New York, United States, 10016
        • Dr Patrick Hennessey
      • New York, New York, United States, 10021
        • New York Hosp - Cornell Med Ctr
      • Stony Brook, New York, United States, 117948153
        • SUNY / Health Sciences Ctr at Stony Brook
    • Ohio
      • Cleveland, Ohio, United States, 44106
        • Cleveland Clinic
    • Oklahoma
      • Tulsa, Oklahoma, United States, 741141325
        • Associates Med and Mental Health
    • Oregon
      • Portland, Oregon, United States, 97232
        • Dr Joel Godbey
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19107
        • Philadelphia FIGHT
      • Philadelphia, Pennsylvania, United States, 19146
        • Graduate Hosp
      • Pittsburgh, Pennsylvania, United States, 15206
        • Novum Inc
    • Texas
      • Austin, Texas, United States, 78751
        • Central Texas Med Foundation
      • Dallas, Texas, United States, 75219
        • Dr Christopher McNulty
      • Dallas, Texas, United States, 75219
        • Nelson-Tebedo Community Clinic
      • Houston, Texas, United States, 77006
        • Houston Clinical Research Network
    • Virginia
      • Hampton, Virginia, United States, 23666
        • Hampton Roads Med Specialists
    • Washington
      • Kirkland, Washington, United States, 98034
        • Novum Inc

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Masking: Double

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Immunobiology Research Institute

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

First Submitted

November 2, 1999

First Submitted That Met QC Criteria

August 30, 2001

First Posted (Estimate)

August 31, 2001

Study Record Updates

Last Update Posted (Estimate)

June 24, 2005

Last Update Submitted That Met QC Criteria

June 23, 2005

Last Verified

March 1, 1996

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 015H
  • 07.32.033-93

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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