Clinical trial NCT00002109: 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
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: HIV Infections
Keywords: Thymopentin
Zalcitabine
Didanosine
Drug Therapy, Combination
Zidovudine
Stavudine
Lead sponsor: NIH AIDS Clinical Trials Information Service
Sponsor class: INDUSTRY
First posted: 2001-08-31
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Primary purpose: TREATMENT

Brief summary: 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 ).


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.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Fisher Med Group
state: Arizona
city: Irvine
country: United States
facility: Ctr for Special Immunology
state: California
city: Los Angeles
country: United States
facility: Beer Med Group
state: California
city: Pasadena
country: United States
facility: Gottlieb Med Group
state: California
city: Redwood City
country: United States
facility: AIDS Community Research Consortium
state: California
city: San Diego
country: United States
facility: HIV Research Group
state: California
city: San Francisco
country: United States
facility: Conant Med Group
state: California
city: San Francisco
country: United States
facility: Kaiser Permanente Med Ctr
state: California
city: Sherman Oaks
country: United States
facility: Pacific Oaks Med Group
state: California
city: Torrance
country: United States
facility: Harbor - UCLA Med Ctr
state: California
city: Greenwich
country: United States
facility: Dr Gary Blick
state: Connecticut
city: Washington
country: United States
facility: Dr Larry Bruni
state: District of Columbia
city: Washington
country: United States
facility: Novum Inc
state: District of Columbia
city: Coral Gables
country: United States
facility: Community Research Initiative
state: Florida
city: Fort Lauderdale
country: United States
facility: Ctr for Special Immunology
state: Florida
city: Fort Lauderdale
country: United States
facility: Stratogen of Ft Lauderdale
state: Florida
city: Miami Beach
country: United States
facility: Stratogen of South Florida
state: Florida
city: Tampa
country: United States
facility: Infectious Disease Research Institute Inc
state: Florida
city: Tampa
country: United States
facility: Saint Joseph's Hosp / Infectious Disease Rsch Institute
state: Florida
city: Atlanta
country: United States
facility: West Paces Clinical Research Inc
state: Georgia
city: Chicago
country: United States
facility: Northwestern Univ Med Ctr
state: Illinois
city: Chicago
country: United States
facility: Rush Presbyterian - Saint Luke's Med Ctr
state: Illinois
city: Chicago
country: United States
facility: Ctr for Special Immunology
state: Illinois
city: Indianapolis
country: United States
facility: Infectious Diseases Research Clinic / Indiana Univ Hosp
state: Indiana
city: Wichita
country: United States
facility: Univ of Kansas School of Medicine
state: Kansas
city: Brookline
country: United States
facility: CRI of New England
state: Massachusetts
city: Kansas City
country: United States
facility: Kansas City AIDS Research Consortium
state: Missouri
city: St. Louis
country: United States
facility: Systemic Mycoses Pathogen Study Group / Wash Univ Sch of Med
state: Missouri
city: Albuquerque
country: United States
facility: Lovelace Scientific Resource
state: New Mexico
city: Bronx
country: United States
facility: Van Etten Hosp / Bronx Municipal Hosp Ctr
state: New York
city: New York
country: United States
facility: Dr David DiPietro
state: New York
city: New York
country: United States
facility: Ctr for Special Immunology
state: New York
city: New York
country: United States
facility: Dr Howard A Grossman
state: New York
city: New York
country: United States
facility: Dr Patrick Hennessey
state: New York
city: New York
country: United States
facility: New York Hosp - Cornell Med Ctr
state: New York
city: Stony Brook
country: United States
facility: SUNY / Health Sciences Ctr at Stony Brook
state: New York
city: Cleveland
country: United States
facility: Cleveland Clinic
state: Ohio
city: Tulsa
country: United States
facility: Associates Med and Mental Health
state: Oklahoma
city: Portland
country: United States
facility: Dr Joel Godbey
state: Oregon
city: Philadelphia
country: United States
facility: Philadelphia FIGHT
state: Pennsylvania
city: Philadelphia
country: United States
facility: Graduate Hosp
state: Pennsylvania
city: Pittsburgh
country: United States
facility: Novum Inc
state: Pennsylvania
city: Austin
country: United States
facility: Central Texas Med Foundation
state: Texas
city: Dallas
country: United States
facility: Dr Christopher McNulty
state: Texas
city: Dallas
country: United States
facility: Nelson-Tebedo Community Clinic
state: Texas
city: Houston
country: United States
facility: Houston Clinical Research Network
state: Texas
city: Hampton
country: United States
facility: Hampton Roads Med Specialists
state: Virginia
city: Kirkland
country: United States
facility: Novum Inc
state: Washington
city: Rio Piedras
country: Puerto Rico
facility: Univ of Puerto Rico Med Sciences Campus
city: San Juan
country: Puerto Rico
facility: Initiativa Comunitaria de Investigacion
Study officials:
References: