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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

Primary Purpose

HIV Infections

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Thymopentin
Stavudine
Zidovudine
Zalcitabine
Didanosine
Sponsored by
Immunobiology Research Institute
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for HIV Infections focused on measuring Thymopentin, Zalcitabine, Didanosine, Drug Therapy, Combination, Zidovudine, Stavudine

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Fisher Med Group
  • Ctr for Special Immunology
  • Beer Med Group
  • Gottlieb Med Group
  • AIDS Community Research Consortium
  • HIV Research Group
  • Conant Med Group
  • Kaiser Permanente Med Ctr
  • Pacific Oaks Med Group
  • Harbor - UCLA Med Ctr
  • Dr Gary Blick
  • Dr Larry Bruni
  • Novum Inc
  • Community Research Initiative
  • Ctr for Special Immunology
  • Stratogen of Ft Lauderdale
  • Stratogen of South Florida
  • Infectious Disease Research Institute Inc
  • Saint Joseph's Hosp / Infectious Disease Rsch Institute
  • West Paces Clinical Research Inc
  • Northwestern Univ Med Ctr
  • Rush Presbyterian - Saint Luke's Med Ctr
  • Ctr for Special Immunology
  • Infectious Diseases Research Clinic / Indiana Univ Hosp
  • Univ of Kansas School of Medicine
  • CRI of New England
  • Kansas City AIDS Research Consortium
  • Systemic Mycoses Pathogen Study Group / Wash Univ Sch of Med
  • Lovelace Scientific Resource
  • Van Etten Hosp / Bronx Municipal Hosp Ctr
  • Dr David DiPietro
  • Ctr for Special Immunology
  • Dr Howard A Grossman
  • Dr Patrick Hennessey
  • New York Hosp - Cornell Med Ctr
  • SUNY / Health Sciences Ctr at Stony Brook
  • Cleveland Clinic
  • Associates Med and Mental Health
  • Dr Joel Godbey
  • Philadelphia FIGHT
  • Graduate Hosp
  • Novum Inc
  • Central Texas Med Foundation
  • Dr Christopher McNulty
  • Nelson-Tebedo Community Clinic
  • Houston Clinical Research Network
  • Hampton Roads Med Specialists
  • Novum Inc
  • Univ of Puerto Rico Med Sciences Campus
  • Initiativa Comunitaria de Investigacion

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
November 2, 1999
Last Updated
June 23, 2005
Sponsor
Immunobiology Research Institute
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1. Study Identification

Unique Protocol Identification Number
NCT00002109
Brief 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
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
Study Type
Interventional

2. Study Status

Record Verification Date
March 1996
Overall Recruitment Status
Completed
Study Start Date
undefined (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Immunobiology Research Institute

4. Oversight

5. Study Description

Brief Summary
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 ).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV Infections
Keywords
Thymopentin, Zalcitabine, Didanosine, Drug Therapy, Combination, Zidovudine, Stavudine

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Masking
Double

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Thymopentin
Intervention Type
Drug
Intervention Name(s)
Stavudine
Intervention Type
Drug
Intervention Name(s)
Zidovudine
Intervention Type
Drug
Intervention Name(s)
Zalcitabine
Intervention Type
Drug
Intervention Name(s)
Didanosine

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Facility Information:
Facility Name
Fisher Med Group
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85013
Country
United States
Facility Name
Ctr for Special Immunology
City
Irvine
State/Province
California
ZIP/Postal Code
92718
Country
United States
Facility Name
Beer Med Group
City
Los Angeles
State/Province
California
ZIP/Postal Code
90036
Country
United States
Facility Name
Gottlieb Med Group
City
Pasadena
State/Province
California
ZIP/Postal Code
90112
Country
United States
Facility Name
AIDS Community Research Consortium
City
Redwood City
State/Province
California
ZIP/Postal Code
94063
Country
United States
Facility Name
HIV Research Group
City
San Diego
State/Province
California
ZIP/Postal Code
92102
Country
United States
Facility Name
Conant Med Group
City
San Francisco
State/Province
California
ZIP/Postal Code
94115
Country
United States
Facility Name
Kaiser Permanente Med Ctr
City
San Francisco
State/Province
California
ZIP/Postal Code
94115
Country
United States
Facility Name
Pacific Oaks Med Group
City
Sherman Oaks
State/Province
California
ZIP/Postal Code
91403
Country
United States
Facility Name
Harbor - UCLA Med Ctr
City
Torrance
State/Province
California
ZIP/Postal Code
90502
Country
United States
Facility Name
Dr Gary Blick
City
Greenwich
State/Province
Connecticut
ZIP/Postal Code
06830
Country
United States
Facility Name
Dr Larry Bruni
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20003
Country
United States
Facility Name
Novum Inc
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20037
Country
United States
Facility Name
Community Research Initiative
City
Coral Gables
State/Province
Florida
ZIP/Postal Code
33146
Country
United States
Facility Name
Ctr for Special Immunology
City
Fort Lauderdale
State/Province
Florida
ZIP/Postal Code
33316
Country
United States
Facility Name
Stratogen of Ft Lauderdale
City
Fort Lauderdale
State/Province
Florida
ZIP/Postal Code
33334
Country
United States
Facility Name
Stratogen of South Florida
City
Miami Beach
State/Province
Florida
ZIP/Postal Code
33140
Country
United States
Facility Name
Infectious Disease Research Institute Inc
City
Tampa
State/Province
Florida
ZIP/Postal Code
33614
Country
United States
Facility Name
Saint Joseph's Hosp / Infectious Disease Rsch Institute
City
Tampa
State/Province
Florida
ZIP/Postal Code
33614
Country
United States
Facility Name
West Paces Clinical Research Inc
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30327
Country
United States
Facility Name
Northwestern Univ Med Ctr
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Facility Name
Rush Presbyterian - Saint Luke's Med Ctr
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
Facility Name
Ctr for Special Immunology
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60657
Country
United States
Facility Name
Infectious Diseases Research Clinic / Indiana Univ Hosp
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States
Facility Name
Univ of Kansas School of Medicine
City
Wichita
State/Province
Kansas
ZIP/Postal Code
67214
Country
United States
Facility Name
CRI of New England
City
Brookline
State/Province
Massachusetts
ZIP/Postal Code
02445
Country
United States
Facility Name
Kansas City AIDS Research Consortium
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
641082792
Country
United States
Facility Name
Systemic Mycoses Pathogen Study Group / Wash Univ Sch of Med
City
St. Louis
State/Province
Missouri
ZIP/Postal Code
63108
Country
United States
Facility Name
Lovelace Scientific Resource
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87108
Country
United States
Facility Name
Van Etten Hosp / Bronx Municipal Hosp Ctr
City
Bronx
State/Province
New York
ZIP/Postal Code
10461
Country
United States
Facility Name
Dr David DiPietro
City
New York
State/Province
New York
ZIP/Postal Code
10001
Country
United States
Facility Name
Ctr for Special Immunology
City
New York
State/Province
New York
ZIP/Postal Code
10010
Country
United States
Facility Name
Dr Howard A Grossman
City
New York
State/Province
New York
ZIP/Postal Code
10014
Country
United States
Facility Name
Dr Patrick Hennessey
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
Facility Name
New York Hosp - Cornell Med Ctr
City
New York
State/Province
New York
ZIP/Postal Code
10021
Country
United States
Facility Name
SUNY / Health Sciences Ctr at Stony Brook
City
Stony Brook
State/Province
New York
ZIP/Postal Code
117948153
Country
United States
Facility Name
Cleveland Clinic
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44106
Country
United States
Facility Name
Associates Med and Mental Health
City
Tulsa
State/Province
Oklahoma
ZIP/Postal Code
741141325
Country
United States
Facility Name
Dr Joel Godbey
City
Portland
State/Province
Oregon
ZIP/Postal Code
97232
Country
United States
Facility Name
Philadelphia FIGHT
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107
Country
United States
Facility Name
Graduate Hosp
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19146
Country
United States
Facility Name
Novum Inc
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15206
Country
United States
Facility Name
Central Texas Med Foundation
City
Austin
State/Province
Texas
ZIP/Postal Code
78751
Country
United States
Facility Name
Dr Christopher McNulty
City
Dallas
State/Province
Texas
ZIP/Postal Code
75219
Country
United States
Facility Name
Nelson-Tebedo Community Clinic
City
Dallas
State/Province
Texas
ZIP/Postal Code
75219
Country
United States
Facility Name
Houston Clinical Research Network
City
Houston
State/Province
Texas
ZIP/Postal Code
77006
Country
United States
Facility Name
Hampton Roads Med Specialists
City
Hampton
State/Province
Virginia
ZIP/Postal Code
23666
Country
United States
Facility Name
Novum Inc
City
Kirkland
State/Province
Washington
ZIP/Postal Code
98034
Country
United States
Facility Name
Univ of Puerto Rico Med Sciences Campus
City
Rio Piedras
ZIP/Postal Code
00935
Country
Puerto Rico
Facility Name
Initiativa Comunitaria de Investigacion
City
San Juan
ZIP/Postal Code
00902
Country
Puerto Rico

12. IPD Sharing Statement

Learn more about this trial

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

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