Search / Trial NCT00000692

Phase I Rising Dose Tolerability Study of SC-48334 in Patients With Acquired Immunodeficiency Syndrome (AIDS) and Advanced AIDS Related Complex

Launched by G D SEARLE · Aug 30, 2001

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Trial Information

Current as of July 14, 2024

Completed

Keywords

Acquired Immunodeficiency Syndrome Aids Related Complex Antiviral Agents Biological Availability 1 Deoxynojirimycin

Description

SC-48334 is a chemical that prevents the biochemical actions of certain enzymes in the body, and recent studies have shown that it may also prevent the activity of HIV. The study will attempt to show whether SC-48334 can safely and effectively break the cycle of HIV infection in AIDS and advanced ARC by progressively eliminating HIV. Six patients are enrolled sequentially into each of eight different dose levels and the drug is administered by mouth at least 60 minutes before meals according to the following schedule: Day 1: One-quarter of total assigned daily dose. Patients receive the do...

Gender

All

Eligibility criteria

  • Inclusion Criteria
  • Concurrent Medication:
  • Allowed:
  • Aerosolized pentamidine.
  • Nystatin.
  • Clotrimazole.
  • Topical acyclovir.
  • Concurrent Treatment:
  • Allowed:
  • Blood transfusions for = or > grade 3 hemoglobin toxicity.
  • Exclusion Criteria
  • Co-existing Condition:
  • Patients with the following conditions will be excluded:
  • Clinical significant diarrhea (> 3 stools per day for > 7 days without definable cause).
  • Active opportunistic infection, requiring ongoing therapy, at time of enrollment.
  • Any malignancy besides Kaposi's sarcoma, basal cell carcinoma, or squamous cell carcinoma unless the squamous cell carcinoma requires ongoing therapy.
  • Neurologic disease including dementia, peripheral neuropathy, myelopathy (CDC category IVb).
  • Concurrent Medication:
  • Excluded:
  • Antimetabolites.
  • Alkylating agents.
  • Drugs with known hepatic or bone marrow toxicity.
  • Patients with significant organ dysfunction will be excluded.
  • Prior Medication:
  • Excluded:
  • Antimetabolites.
  • Alkylating agents.
  • Excluded within 30 days of study entry:
  • Any investigational medication.
  • Drugs with anti-HIV activity.
  • Excluded within 90 days of study entry:
  • Ribavirin treatment.
  • Excluded within 6 months of study entry:
  • Cancer chemotherapy.
  • Prior Treatment:
  • Excluded within 6 months of study entry:
  • Radiation therapy.
  • Patients must demonstrate the following clinical and laboratory findings:
  • AIDS or advanced AIDS related complex (ARC), according to Centers for Disease Control (CDC) category IV, excluding neurologic disease in IVb.
  • Ability to understand the terms of study participation.
  • Current use of illicit drugs or abuse of alcohol.

Attachments

readout_NCT00000692_2024-07-14.pdf

4.5 MB

NCT00000692_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

West Columbia, South Carolina, United States

Chicago, Illinois, United States

San Diego, California, United States

Miami, Florida, United States

Stanford, California, United States

Boston, 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

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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