Search / Trial NCT00000976

A Phase I Study of the Safety and Pharmacokinetics of Recombinant Human CD4-Immunoglobulin G (rCD4-IgG) Administered by Intravenous Bolus Injection in Combination With Oral Zidovudine in Patients With AIDS and AIDS-Related Complex

Launched by NATIONAL INSTITUTE OF ALLERGY AND INFECTIOUS DISEASES (NIAID) · Aug 30, 2001

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Trial Information

Current as of March 02, 2024

Completed

Keywords

Recombinant Proteins Injections, Intravenous Ig G Drug Evaluation Administration, Oral Acquired Immunodeficiency Syndrome Antigens, Cd4 Zidovudine Carrier Proteins

Description

Treatment of AIDS has been directed toward the underlying retroviral infection as well as toward specific opportunistic infections and malignancies that are associated with the syndrome. The most extensively studied drugs are reverse transcriptase inhibitors such as AZT and other nucleoside analogs, including didanosine (ddI) and dideoxycytidine (ddC). The most extensive clinical experience has been achieved with AZT. These clinical trials indicated a decreased incidence of opportunistic infection and increased survival in patients with AIDS. However, AZT treatment is associated with dose-l...

Gender

All

Eligibility criteria

  • Inclusion Criteria
  • Concurrent Medication:
  • Allowed:
  • Topical acyclovir.
  • Patients must have the following:
  • HIV seropositivity.
  • Life expectancy of at least 3 months.
  • No white or red blood cell casts in urine.
  • Exclusion Criteria
  • Co-existing Condition:
  • Patients with the following conditions or symptoms are excluded:
  • Serious active opportunistic infection or malignancies other than Kaposi's sarcoma.
  • Kaposi's sarcoma requiring therapy, tumor-associated edema, or visceral disease.
  • Concurrent Medication:
  • Excluded:
  • Intravenous acyclovir for Herpes.
  • Interferon.
  • Systemic corticosteroids.
  • Nonsteroidal anti-inflammatory agents.
  • Intravenous acyclovir.
  • Other known immunomodulatory agents.
  • Dideoxycytosine (ddC), didanosine (ddI).
  • Other nucleoside analogs not specifically allowed.
  • Other experimental therapy.
  • Patients with the following are excluded:
  • Serious active opportunistic infection or malignancies other than Kaposi's sarcoma.
  • More than 120 days (total) of prior zidovudine (AZT) therapy.
  • Currently receiving intravenous acyclovir for Herpes.
  • Prior Medication:
  • Excluded:
  • > 120 days total of prior zidovudine (AZT) therapy.
  • Excluded within 3 weeks of study entry:
  • Immunomodulatory agents.
  • Other experimental therapy.
  • Prior Treatment:
  • Excluded within the past 3 months:
  • Transfusion.

Attachments

readout_NCT00000976_2024-03-02.pdf

4.5 MB

NCT00000976_study_protocol.pdf

4.5 MB

About company

The National Institute of Allergy and Infectious Diseases (NIAID, /ˈnaɪ.æd/) is one of the 27 institutes and centers that make up the National Institutes of Health (NIH), an agency of the United States Department of Health and Human Services (HHS). NIAID's mission is to conduct basic and applied research to better understand, treat, and prevent infectious, immunologic, and allergic diseases.

Contacts

JC

Jennifer Cobb

Immunology at National Institute of Allergy and Infectious Diseases (NIAID)

Locations

San Diego, California, United States

Miami, Florida, United States

Worcester, Massachusetts, United States

People applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

Reviews (48)

4.6

All reviews come from applied patients

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Leslie Alexander
20 September 2023

Duis aute irure dolor in reprehenderit in voluptate velit esse cillum dolore eu fugiat nulla pariatur. Excepteur sint occaecat cupidatat non proident, sunt in culpa qui officia deserunt mollit anim id est laborum?

Michael Foster
20 September 2023

Duis aute irure dolor in reprehenderit in voluptate velit esse cillum dolore eu fugiat nulla pariatur. Excepteur sint occaecat cupidatat non proident, sunt in culpa qui officia deserunt mollit anim id est laborum?

Dries Vincent
20 September 2023

Duis aute irure dolor in reprehenderit in voluptate velit esse cillum dolore eu fugiat nulla pariatur. Excepteur sint occaecat cupidatat non proident, sunt in culpa qui officia deserunt mollit anim id est laborum?

Leslie Alexander
20 September 2023

Duis aute irure dolor in reprehenderit in voluptate velit esse cillum dolore eu fugiat nulla pariatur. Excepteur sint occaecat cupidatat non proident, sunt in culpa qui officia deserunt mollit anim id est laborum?

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