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

Completed · Phase 3

Conditions studied: HIV Infections

In brief

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 ).

Key facts

Study ID

NCT00002109

Run by

Immunobiology Research Institute

Last updated by the study team

2005-06-24

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Fisher Med Group — Phoenix, Arizona, United States
• Ctr for Special Immunology — Irvine, California, United States
• Beer Med Group — Los Angeles, California, United States
• Gottlieb Med Group — Pasadena, California, United States
• AIDS Community Research Consortium — Redwood City, California, United States
• HIV Research Group — San Diego, California, United States
• Conant Med Group — San Francisco, California, United States
• Kaiser Permanente Med Ctr — San Francisco, California, United States
• Pacific Oaks Med Group — Sherman Oaks, California, United States
• Harbor - UCLA Med Ctr — Torrance, California, United States
• Dr Gary Blick — Greenwich, Connecticut, United States
• Dr Larry Bruni — Washington D.C., District of Columbia, United States
• Novum Inc — Washington D.C., District of Columbia, United States
• Community Research Initiative — Coral Gables, Florida, United States
• Ctr for Special Immunology — Fort Lauderdale, Florida, United States
• Stratogen of Ft Lauderdale — Fort Lauderdale, Florida, United States
• Stratogen of South Florida — Miami Beach, Florida, United States
• Infectious Disease Research Institute Inc — Tampa, Florida, United States
• Saint Joseph's Hosp / Infectious Disease Rsch Institute — Tampa, Florida, United States
• West Paces Clinical Research Inc — Atlanta, Georgia, United States
• Northwestern Univ Med Ctr — Chicago, Illinois, United States
• Rush Presbyterian - Saint Luke's Med Ctr — Chicago, Illinois, United States
• Ctr for Special Immunology — Chicago, Illinois, United States
• Infectious Diseases Research Clinic / Indiana Univ Hosp — Indianapolis, Indiana, United States
• Univ of Kansas School of Medicine — Wichita, Kansas, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.