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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
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

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 2, 1999

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 30, 2001

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 31, 2001

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 24, 2005

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 23, 2005

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 1996

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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