Search / Trial NCT00001006

A Study of AS-101 in Patients With AIDS or AIDS Related Complex (ARC)

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

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Trial Information

Current as of June 14, 2024

Completed

Keywords

Infusions, Intravenous Immunologic Surveillance Drug Evaluation Adjuvants, Immunologic Acquired Immunodeficiency Syndrome Aids Related Complex Ammonium Trichloro(dioxoethylene O,O' )Tellurute

Description

AIDS is a viral disease that is characterized by a loss of some immune function and the development of frequent, eventually fatal, infectious diseases. Although zidovudine (AZT) has prolonged survival in some patients with AIDS, AZT is quite toxic and there is a need for more effective and less toxic drugs. AS-101 is a synthetic organic compound containing the metal tellurium that is being tested because in laboratory studies it improved immune functions. Patients are given intravenous infusions of AS-101 3 times a week for 12 weeks. The first group of 6 patients receives a dose that did n...

Gender

All

Eligibility criteria

  • Inclusion Criteria
  • Concurrent Medication:
  • Allowed:
  • Inhaled pentamidine for Pneumocystis carinii pneumonia (PCP) prophylaxis.
  • Ketoconazole.
  • Standard outpatient therapy for infections developing during the trial.
  • Oral acyclovir for up to 7 days.
  • Patients must have:
  • Antibody to HIV by ELISA.
  • AIDS or AIDS related complex (ARC).
  • T4 cell count < 400 cells/mm3 on 2 determinations at least 72 hours apart.
  • Prior Medication:
  • Allowed:
  • Inhaled pentamidine for Pneumocystis carinii pneumonia (PCP) prophylaxis.
  • Ketoconazole.
  • Oral acyclovir for up to 7 days.
  • Exclusion Criteria
  • Co-existing Condition:
  • Patients with the following conditions or symptoms are excluded:
  • Active opportunistic infection or malignancy requiring concurrent treatment.
  • Serious medical problems, such as diabetes, renal disease, ASHD, or hypertension, which would complicate interpretation of treatment results.
  • Transfusion requirements exceeding 2 transfusions per month in order to achieve hemoglobin > 9 g/dl.
  • Concurrent Medication:
  • Excluded:
  • Treatment for active opportunistic infection or malignancy.
  • Systemic antiviral preparations.
  • Immunosuppressive agents.
  • Immunostimulation therapy.
  • Specific therapy for Kaposi's sarcoma or other malignancies.
  • Concurrent Treatment:
  • Excluded:
  • More than 2 units of red blood cell transfusions per month in order to achieve hemoglobin > 8 g/dl.
  • Patients unlikely or unable, for reasons such as distance from the hospital or psychological considerations, to comply with the requirements of the protocol, especially in regard to regular attendance for treatment, are excluded.
  • Prior Medication:
  • Excluded:
  • Systemic antiviral preparations.
  • Isoprinosine.
  • Excluded with 1 month of study entry:
  • Immunosuppressive agents.
  • Immunomodulators.
  • Prior Treatment:
  • Excluded:
  • Immunostimulation therapy, such as BCG vaccine.
  • Active drug or alcohol abuse.

Attachments

readout_NCT00001006_2024-06-14.pdf

4.5 MB

NCT00001006_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

New York, New York, 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

5 stars
41
4 stars
6
3 stars
2
2 stars
0
1 stars
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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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