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	Treatment or Intervention	Phase
HIV Infections	Drug: Thymopentin  Drug: Stavudine  Drug: Zidovudine  Drug: Zalcitabine  Drug: Didanosine	Phase III

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  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.

Arizona
      Fisher Med Group, Phoenix,  Arizona,  85013,  United States
California
      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
Connecticut
      Dr Gary Blick, Greenwich,  Connecticut,  06830,  United States
District of Columbia
      Dr Larry Bruni, Washington,  District of Columbia,  20003,  United States
      Novum Inc, Washington,  District of Columbia,  20037,  United States
Florida
      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
Georgia
      West Paces Clinical Research Inc, Atlanta,  Georgia,  30327,  United States
Illinois
      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
Indiana
      Infectious Diseases Research Clinic / Indiana Univ Hosp, Indianapolis,  Indiana,  46202,  United States
Kansas
      Univ of Kansas School of Medicine, Wichita,  Kansas,  67214,  United States
Massachusetts
      CRI of New England, Brookline,  Massachusetts,  02445,  United States
Missouri
      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
New Mexico
      Lovelace Scientific Resource, Albuquerque,  New Mexico,  87108,  United States
New York
      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
Ohio
      Cleveland Clinic, Cleveland,  Ohio,  44106,  United States
Oklahoma
      Associates Med and Mental Health, Tulsa,  Oklahoma,  741141325,  United States
Oregon
      Dr Joel Godbey, Portland,  Oregon,  97232,  United States
Pennsylvania
      Novum Inc, Pittsburgh,  Pennsylvania,  15206,  United States
      Graduate Hosp, Philadelphia,  Pennsylvania,  19146,  United States
      Philadelphia FIGHT, Philadelphia,  Pennsylvania,  19107,  United States
Texas
      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
Virginia
      Hampton Roads Med Specialists, Hampton,  Virginia,  23666,  United States
Washington
      Novum Inc, Kirkland,  Washington,  98034,  United States
Puerto Rico
      Initiativa Comunitaria de Investigacion, San Juan,  00902,  Puerto Rico
      Univ of Puerto Rico Med Sciences Campus, Rio Piedras,  00935,  Puerto Rico

Study ID Numbers:  015H; 07.32.033-93
Record last reviewed:  March 1996
Last Updated:  October 13, 2004
Record first received:  November 2, 1999
ClinicalTrials.gov Identifier:  NCT00002109
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-04-08