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.
Sponsor:
Information provided by:
NIH AIDS Clinical Trials Information Service
ClinicalTrials.gov Identifier:
NCT00002109
First received: November 2, 1999
Last updated: June 23, 2005
Last verified: March 1996
  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 3

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Masking: Double-Blind
Primary Purpose: Treatment
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:


Further study details as provided by NIH AIDS Clinical Trials Information Service:

  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

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

No publications provided

ClinicalTrials.gov Identifier: NCT00002109     History of Changes
Other Study ID Numbers: 015H, 07.32.033-93
Study First Received: November 2, 1999
Last Updated: June 23, 2005
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:
HIV Infections
Acquired Immunodeficiency Syndrome
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases
Zalcitabine
Didanosine
Zidovudine
Stavudine
Thymopentin
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Reverse Transcriptase Inhibitors
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Anti-HIV Agents
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on July 20, 2014