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
2 other identifiers
interventional
N/A
2 countries
50
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 ).
Trial Health
Trial Health Score
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50 active sites
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Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 2, 1999
CompletedFirst Posted
Study publicly available on registry
August 31, 2001
CompletedJune 24, 2005
March 1, 1996
November 2, 1999
June 23, 2005
Conditions
Keywords
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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).
- +17 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (50)
Fisher Med Group
Phoenix, Arizona, 85013, United States
Ctr for Special Immunology
Irvine, California, 92718, United States
Beer Med Group
Los Angeles, California, 90036, United States
Gottlieb Med Group
Pasadena, California, 90112, United States
AIDS Community Research Consortium
Redwood City, California, 94063, United States
HIV Research Group
San Diego, California, 92102, United States
Conant Med Group
San Francisco, California, 94115, United States
Kaiser Permanente Med Ctr
San Francisco, California, 94115, United States
Pacific Oaks Med Group
Sherman Oaks, California, 91403, United States
Harbor - UCLA Med Ctr
Torrance, California, 90502, United States
Dr Gary Blick
Greenwich, Connecticut, 06830, United States
Dr Larry Bruni
Washington D.C., District of Columbia, 20003, United States
Novum Inc
Washington D.C., District of Columbia, 20037, United States
Community Research Initiative
Coral Gables, Florida, 33146, United States
Ctr for Special Immunology
Fort Lauderdale, Florida, 33316, United States
Stratogen of Ft Lauderdale
Fort Lauderdale, Florida, 33334, United States
Stratogen of South Florida
Miami Beach, Florida, 33140, United States
Infectious Disease Research Institute Inc
Tampa, Florida, 33614, United States
Saint Joseph's Hosp / Infectious Disease Rsch Institute
Tampa, Florida, 33614, United States
West Paces Clinical Research Inc
Atlanta, Georgia, 30327, United States
Northwestern Univ Med Ctr
Chicago, Illinois, 60611, United States
Rush Presbyterian - Saint Luke's Med Ctr
Chicago, Illinois, 60612, United States
Ctr for Special Immunology
Chicago, Illinois, 60657, United States
Infectious Diseases Research Clinic / Indiana Univ Hosp
Indianapolis, Indiana, 46202, United States
Univ of Kansas School of Medicine
Wichita, Kansas, 67214, United States
CRI of New England
Brookline, Massachusetts, 02445, United States
Kansas City AIDS Research Consortium
Kansas City, Missouri, 641082792, United States
Systemic Mycoses Pathogen Study Group / Wash Univ Sch of Med
St Louis, Missouri, 63108, United States
Lovelace Scientific Resource
Albuquerque, New Mexico, 87108, United States
Dr David DiPietro
New York, New York, 10001, United States
Ctr for Special Immunology
New York, New York, 10010, United States
Dr Howard A Grossman
New York, New York, 10014, United States
Dr Patrick Hennessey
New York, New York, 10016, United States
New York Hosp - Cornell Med Ctr
New York, New York, 10021, United States
SUNY / Health Sciences Ctr at Stony Brook
Stony Brook, New York, 117948153, United States
Van Etten Hosp / Bronx Municipal Hosp Ctr
The Bronx, New York, 10461, United States
Cleveland Clinic
Cleveland, Ohio, 44106, United States
Associates Med and Mental Health
Tulsa, Oklahoma, 741141325, United States
Dr Joel Godbey
Portland, Oregon, 97232, United States
Philadelphia FIGHT
Philadelphia, Pennsylvania, 19107, United States
Graduate Hosp
Philadelphia, Pennsylvania, 19146, United States
Novum Inc
Pittsburgh, Pennsylvania, 15206, United States
Central Texas Med Foundation
Austin, Texas, 78751, United States
Dr Christopher McNulty
Dallas, Texas, 75219, United States
Nelson-Tebedo Community Clinic
Dallas, Texas, 75219, United States
Houston Clinical Research Network
Houston, Texas, 77006, United States
Hampton Roads Med Specialists
Hampton, Virginia, 23666, United States
Novum Inc
Kirkland, Washington, 98034, United States
Univ of Puerto Rico Med Sciences Campus
Rio Piedras, 00935, Puerto Rico
Initiativa Comunitaria de Investigacion
San Juan, 00902, Puerto Rico