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| Sponsor: | Immunobiology Research Institute |
|---|---|
| Information provided by: | NIH AIDS Clinical Trials Information Service |
| ClinicalTrials.gov Identifier: | NCT00002109 |
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 III |
| Study Type: | Interventional |
| Study Design: | Treatment, Double-Blind, Safety Study |
| 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 |
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria
Patients must have:
Exclusion Criteria
Co-existing Condition:
Patients with the following symptoms or conditions are excluded:
Concurrent Medication:
Excluded:
Patients with the following prior conditions are excluded:
Prior Medication:
Excluded at any time prior to study entry:
More than one dose of thymopentin.
Excluded within 30 days prior to study entry:
Required:
Significant active alcohol or drug abuse.
Contacts and Locations
Hide Study Locations| United States, Arizona | |
| Fisher Med Group | |
| Phoenix, Arizona, United States, 85013 | |
| United States, California | |
| 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 | |
| Harbor - UCLA Med Ctr | |
| Torrance, California, United States, 90502 | |
| Pacific Oaks Med Group | |
| Sherman Oaks, California, United States, 91403 | |
| Kaiser Permanente Med Ctr | |
| San Francisco, California, United States, 94115 | |
| Beer Med Group | |
| Los Angeles, California, United States, 90036 | |
| Gottlieb Med Group | |
| Pasadena, California, United States, 90112 | |
| Ctr for Special Immunology | |
| Irvine, California, United States, 92718 | |
| 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 South Florida | |
| Miami Beach, Florida, United States, 33140 | |
| Infectious Disease Research Institute Inc | |
| Tampa, Florida, United States, 33614 | |
| Ctr for Special Immunology | |
| Fort Lauderdale, Florida, United States, 33316 | |
| Saint Joseph's Hosp / Infectious Disease Rsch Institute | |
| Tampa, Florida, United States, 33614 | |
| Stratogen of Ft Lauderdale | |
| Fort Lauderdale, Florida, United States, 33334 | |
| 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 | |
| Systemic Mycoses Pathogen Study Group / Wash Univ Sch of Med | |
| St. Louis, Missouri, United States, 63108 | |
| Kansas City AIDS Research Consortium | |
| Kansas City, Missouri, United States, 641082792 | |
| United States, New Mexico | |
| Lovelace Scientific Resource | |
| Albuquerque, New Mexico, United States, 87108 | |
| United States, New York | |
| Dr David DiPietro | |
| New York, New York, United States, 10001 | |
| Dr Patrick Hennessey | |
| New York, New York, United States, 10016 | |
| Dr Howard A Grossman | |
| New York, New York, United States, 10014 | |
| SUNY / Health Sciences Ctr at Stony Brook | |
| Stony Brook, New York, United States, 117948153 | |
| 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 | |
| Ctr for Special Immunology | |
| New York, New York, United States, 10010 | |
| 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 | |
| Novum Inc | |
| Pittsburgh, Pennsylvania, United States, 15206 | |
| Graduate Hosp | |
| Philadelphia, Pennsylvania, United States, 19146 | |
| Philadelphia FIGHT | |
| Philadelphia, Pennsylvania, United States, 19107 | |
| United States, Texas | |
| Houston Clinical Research Network | |
| Houston, Texas, United States, 77006 | |
| Nelson-Tebedo Community Clinic | |
| Dallas, Texas, United States, 75219 | |
| Central Texas Med Foundation | |
| Austin, Texas, United States, 78751 | |
| Dr Christopher McNulty | |
| Dallas, Texas, United States, 75219 | |
| United States, Virginia | |
| Hampton Roads Med Specialists | |
| Hampton, Virginia, United States, 23666 | |
| United States, Washington | |
| Novum Inc | |
| Kirkland, Washington, United States, 98034 | |
| Puerto Rico | |
| Initiativa Comunitaria de Investigacion | |
| San Juan, Puerto Rico, 00902 | |
| Univ of Puerto Rico Med Sciences Campus | |
| Rio Piedras, Puerto Rico, 00935 | |
More Information
| Study ID Numbers: | 015H, 07.32.033-93 |
| Study First Received: | November 2, 1999 |
| Last Updated: | June 23, 2005 |
| ClinicalTrials.gov Identifier: | NCT00002109 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
|
Thymopentin Zalcitabine Didanosine |
Drug Therapy, Combination Zidovudine Stavudine |
|
Antimetabolites Anti-Infective Agents Sexually Transmitted Diseases, Viral Slow Virus Diseases Stavudine Immunologic Factors Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs Zidovudine Infection Reverse Transcriptase Inhibitors Anti-Retroviral Agents Therapeutic Uses Thymopentin Retroviridae Infections |
Nucleic Acid Synthesis Inhibitors RNA Virus Infections Anti-HIV Agents Immune System Diseases Zalcitabine Acquired Immunodeficiency Syndrome Adjuvants, Immunologic Enzyme Inhibitors Antiviral Agents Immunologic Deficiency Syndromes Pharmacologic Actions Virus Diseases Didanosine HIV Infections Sexually Transmitted Diseases |