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
HIV Infections

About this trial
This is an interventional treatment trial for HIV Infections focused on measuring Thymopentin, Zalcitabine, Didanosine, Drug Therapy, Combination, Zidovudine, Stavudine
Eligibility 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.
Sites / Locations
- Fisher Med Group
- Ctr for Special Immunology
- Beer Med Group
- Gottlieb Med Group
- AIDS Community Research Consortium
- HIV Research Group
- Conant Med Group
- Kaiser Permanente Med Ctr
- Pacific Oaks Med Group
- Harbor - UCLA Med Ctr
- Dr Gary Blick
- Dr Larry Bruni
- Novum Inc
- Community Research Initiative
- Ctr for Special Immunology
- Stratogen of Ft Lauderdale
- Stratogen of South Florida
- Infectious Disease Research Institute Inc
- Saint Joseph's Hosp / Infectious Disease Rsch Institute
- West Paces Clinical Research Inc
- Northwestern Univ Med Ctr
- Rush Presbyterian - Saint Luke's Med Ctr
- Ctr for Special Immunology
- Infectious Diseases Research Clinic / Indiana Univ Hosp
- Univ of Kansas School of Medicine
- CRI of New England
- Kansas City AIDS Research Consortium
- Systemic Mycoses Pathogen Study Group / Wash Univ Sch of Med
- Lovelace Scientific Resource
- Van Etten Hosp / Bronx Municipal Hosp Ctr
- Dr David DiPietro
- Ctr for Special Immunology
- Dr Howard A Grossman
- Dr Patrick Hennessey
- New York Hosp - Cornell Med Ctr
- SUNY / Health Sciences Ctr at Stony Brook
- Cleveland Clinic
- Associates Med and Mental Health
- Dr Joel Godbey
- Philadelphia FIGHT
- Graduate Hosp
- Novum Inc
- Central Texas Med Foundation
- Dr Christopher McNulty
- Nelson-Tebedo Community Clinic
- Houston Clinical Research Network
- Hampton Roads Med Specialists
- Novum Inc
- Univ of Puerto Rico Med Sciences Campus
- Initiativa Comunitaria de Investigacion