HIV Infections Clinical Trial
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
| NCT number | NCT00002109 |
| Other study ID # | 015H |
| Secondary ID | 07.32.033-93 |
| Status | Completed |
| Phase | Phase 3 |
| First received | November 2, 1999 |
| Last updated | June 23, 2005 |
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 ).
| Status | Completed |
| Enrollment | 0 |
| Est. completion date | |
| Est. primary completion date | |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years and older |
| Eligibility |
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. |
Endpoint Classification: Safety Study, Masking: Double-Blind, Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| Puerto Rico | Univ of Puerto Rico Med Sciences Campus | Rio Piedras | |
| Puerto Rico | Initiativa Comunitaria de Investigacion | San Juan | |
| United States | Lovelace Scientific Resource | Albuquerque | New Mexico |
| United States | West Paces Clinical Research Inc | Atlanta | Georgia |
| United States | Central Texas Med Foundation | Austin | Texas |
| United States | Van Etten Hosp / Bronx Municipal Hosp Ctr | Bronx | New York |
| United States | CRI of New England | Brookline | Massachusetts |
| United States | Ctr for Special Immunology | Chicago | Illinois |
| United States | Northwestern Univ Med Ctr | Chicago | Illinois |
| United States | Rush Presbyterian - Saint Luke's Med Ctr | Chicago | Illinois |
| United States | Cleveland Clinic | Cleveland | Ohio |
| United States | Community Research Initiative | Coral Gables | Florida |
| United States | Dr Christopher McNulty | Dallas | Texas |
| United States | Nelson-Tebedo Community Clinic | Dallas | Texas |
| United States | Ctr for Special Immunology | Fort Lauderdale | Florida |
| United States | Stratogen of Ft Lauderdale | Fort Lauderdale | Florida |
| United States | Dr Gary Blick | Greenwich | Connecticut |
| United States | Hampton Roads Med Specialists | Hampton | Virginia |
| United States | Houston Clinical Research Network | Houston | Texas |
| United States | Infectious Diseases Research Clinic / Indiana Univ Hosp | Indianapolis | Indiana |
| United States | Ctr for Special Immunology | Irvine | California |
| United States | Kansas City AIDS Research Consortium | Kansas City | Missouri |
| United States | Novum Inc | Kirkland | Washington |
| United States | Beer Med Group | Los Angeles | California |
| United States | Stratogen of South Florida | Miami Beach | Florida |
| United States | Ctr for Special Immunology | New York | New York |
| United States | Dr David DiPietro | New York | New York |
| United States | Dr Howard A Grossman | New York | New York |
| United States | Dr Patrick Hennessey | New York | New York |
| United States | New York Hosp - Cornell Med Ctr | New York | New York |
| United States | Gottlieb Med Group | Pasadena | California |
| United States | Graduate Hosp | Philadelphia | Pennsylvania |
| United States | Philadelphia FIGHT | Philadelphia | Pennsylvania |
| United States | Fisher Med Group | Phoenix | Arizona |
| United States | Novum Inc | Pittsburgh | Pennsylvania |
| United States | Dr Joel Godbey | Portland | Oregon |
| 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 | Systemic Mycoses Pathogen Study Group / Wash Univ Sch of Med | St. Louis | Missouri |
| United States | SUNY / Health Sciences Ctr at Stony Brook | Stony Brook | New York |
| United States | Infectious Disease Research Institute Inc | Tampa | Florida |
| United States | Saint Joseph's Hosp / Infectious Disease Rsch Institute | Tampa | Florida |
| United States | Harbor - UCLA Med Ctr | Torrance | California |
| United States | Associates Med and Mental Health | Tulsa | Oklahoma |
| United States | Dr Larry Bruni | Washington | District of Columbia |
| United States | Novum Inc | Washington | District of Columbia |
| United States | Univ of Kansas School of Medicine | Wichita | Kansas |
| Lead Sponsor | Collaborator |
|---|---|
| Immunobiology Research Institute |
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