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Double-Blind Study of Timunox...

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

Last Updated: 2005-06-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Study Classification

INTERVENTIONAL

Brief Summary

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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 ).

Detailed Description

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Conditions

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HIV Infections

Study Design

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Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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Thymopentin

Intervention Type DRUG

Stavudine

Intervention Type DRUG

Zidovudine

Intervention Type DRUG

Zalcitabine

Intervention Type DRUG

Didanosine

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Locations

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Fisher Med Group

Phoenix, Arizona, United States

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Ctr for Special Immunology

Irvine, California, United States

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Beer Med Group

Los Angeles, California, United States

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Gottlieb Med Group

Pasadena, California, United States

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AIDS Community Research Consortium

Redwood City, California, United States

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HIV Research Group

San Diego, California, United States

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Conant Med Group

San Francisco, California, United States

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Kaiser Permanente Med Ctr

San Francisco, California, United States

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Pacific Oaks Med Group

Sherman Oaks, California, United States

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Harbor - UCLA Med Ctr

Torrance, California, United States

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Dr Gary Blick

Greenwich, Connecticut, United States

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Dr Larry Bruni

Washington D.C., District of Columbia, United States

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Novum Inc

Washington D.C., District of Columbia, United States

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Community Research Initiative

Coral Gables, Florida, United States

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Ctr for Special Immunology

Fort Lauderdale, Florida, United States

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Stratogen of Ft Lauderdale

Fort Lauderdale, Florida, United States

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Stratogen of South Florida

Miami Beach, Florida, United States

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Infectious Disease Research Institute Inc

Tampa, Florida, United States

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Saint Joseph's Hosp / Infectious Disease Rsch Institute

Tampa, Florida, United States

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West Paces Clinical Research Inc

Atlanta, Georgia, United States

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Northwestern Univ Med Ctr

Chicago, Illinois, United States

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Rush Presbyterian - Saint Luke's Med Ctr

Chicago, Illinois, United States

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Ctr for Special Immunology

Chicago, Illinois, United States

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Infectious Diseases Research Clinic / Indiana Univ Hosp

Indianapolis, Indiana, United States

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Univ of Kansas School of Medicine

Wichita, Kansas, United States

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CRI of New England

Brookline, Massachusetts, United States

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Kansas City AIDS Research Consortium

Kansas City, Missouri, United States

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Systemic Mycoses Pathogen Study Group / Wash Univ Sch of Med

St Louis, Missouri, United States

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