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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

Information source: NIH AIDS Clinical Trials Information Service
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: HIV Infections

Intervention: Thymopentin (Drug); Stavudine (Drug); Zidovudine (Drug); Zalcitabine (Drug); Didanosine (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Immunobiology Research Institute

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 ).

Clinical Details

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 design: Endpoint Classification: Safety Study, Masking: Double-Blind, Primary Purpose: Treatment

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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.

Locations and Contacts

Univ of Puerto Rico Med Sciences Campus, Rio Piedras 00935, Puerto Rico

Initiativa Comunitaria de Investigacion, San Juan 00902, Puerto Rico

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, District of Columbia 20003, United States

Novum Inc, Washington, 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

Ctr for Special Immunology, Chicago, Illinois 60657, United States

Northwestern Univ Med Ctr, Chicago, Illinois 60611, United States

Rush Presbyterian - Saint Luke's Med Ctr, Chicago, Illinois 60612, 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

Van Etten Hosp / Bronx Municipal Hosp Ctr, Bronx, New York 10461, United States

Ctr for Special Immunology, New York, New York 10010, United States

Dr David DiPietro, New York, New York 10001, 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

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

Graduate Hosp, Philadelphia, Pennsylvania 19146, United States

Philadelphia FIGHT, Philadelphia, Pennsylvania 19107, 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

Additional Information


Last updated: June 23, 2005

Page last updated: August 23, 2015

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