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 ).
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.
Initiativa Comunitaria de Investigacion, San Juan 00902, Puerto Rico
Univ of Puerto Rico Med Sciences Campus, Rio Piedras 00935, Puerto Rico
Fisher Med Group, Phoenix, Arizona 85013, United States
AIDS Community Research Consortium, Redwood City, California 94063, United States
HIV Research Group, San Diego, California 92102, United States
Pacific Oaks Med Group, Sherman Oaks, California 91403, United States
Harbor - UCLA Med Ctr, Torrance, California 90502, United States
Conant Med Group, San Francisco, California 94115, United States
Kaiser Permanente Med Ctr, San Francisco, California 94115, United States
Beer Med Group, Los Angeles, California 90036, United States
Gottlieb Med Group, Pasadena, California 90112, United States
Ctr for Special Immunology, Irvine, California 92718, 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
Stratogen of South Florida, Miami Beach, Florida 33140, United States
Infectious Disease Research Institute Inc, Tampa, Florida 33614, United States
Stratogen of Ft Lauderdale, Fort Lauderdale, Florida 33334, United States
Saint Joseph's Hosp / Infectious Disease Rsch Institute, Tampa, Florida 33614, United States
Ctr for Special Immunology, Fort Lauderdale, Florida 33316, 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
Systemic Mycoses Pathogen Study Group / Wash Univ Sch of Med, St. Louis, Missouri 63108, United States
Kansas City AIDS Research Consortium, Kansas City, Missouri 641082792, United States
Lovelace Scientific Resource, Albuquerque, New Mexico 87108, United States
Dr Howard A Grossman, New York, New York 10014, United States
Dr Patrick Hennessey, New York, New York 10016, United States
Dr David DiPietro, New York, New York 10001, United States
SUNY / Health Sciences Ctr at Stony Brook, Stony Brook, New York 117948153, United States
Van Etten Hosp / Bronx Municipal Hosp Ctr, Bronx, New York 10461, United States
New York Hosp - Cornell Med Ctr, New York, New York 10021, United States
Ctr for Special Immunology, New York, New York 10010, 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
Novum Inc, Pittsburgh, Pennsylvania 15206, United States
Graduate Hosp, Philadelphia, Pennsylvania 19146, United States
Philadelphia FIGHT, Philadelphia, Pennsylvania 19107, United States
Houston Clinical Research Network, Houston, Texas 77006, United States
Nelson-Tebedo Community Clinic, Dallas, Texas 75219, United States
Central Texas Med Foundation, Austin, Texas 78751, United States
Dr Christopher McNulty, Dallas, Texas 75219, United States
Hampton Roads Med Specialists, Hampton, Virginia 23666, United States
Novum Inc, Kirkland, Washington 98034, United States
