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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00000692
First Posted: August 31, 2001
Last Update Posted: March 17, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
National Institute of Allergy and Infectious Diseases (NIAID)
Information provided by:
National Institute of Allergy and Infectious Diseases (NIAID)
  Purpose

To determine the following about the use of SC-48334 in patients with AIDS and advanced AIDS related complex (ARC):

1. The largest maximum tolerated dose (MTD); 2. Effectiveness against HIV; 3. Pharmacokinetics - how fast SC-48334 reaches the bloodstream, what concentration is reached, and how long it remains in the patient's blood.

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.


Condition Intervention Phase
HIV Infections Drug: Butyldeoxynojirimycin Phase 1

Study Type: Interventional
Study Design: Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase I Rising Dose Tolerability Study of SC-48334 in Patients With Acquired Immunodeficiency Syndrome (AIDS) and Advanced AIDS Related Complex

Resource links provided by NLM:


Further study details as provided by National Institute of Allergy and Infectious Diseases (NIAID):

Estimated Enrollment: 48
Detailed 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 dosage in the hospital as either an inpatient or outpatient and are observed for 12 hours, during which time they are evaluated and blood is drawn for pharmacokinetic studies. Patients return at 24 and 48 hours for a limited physical examination and additional pharmacokinetic studies. Days 4 - 31: Total assigned daily dose, one-quarter 4 times a day. Patients are observed for at least 5 days in the hospital following the start of this part of the program, during which time clinical, laboratory, and pharmacokinetic information is obtained in order to establish baseline values. After the 6th day, patients are evaluated with a complete physical exam, urinalysis, and laboratory studies once a week and a limited physical exam and brief laboratory studies 3 times a week. At each of the eight dose levels, the second and third patients receive their first dose only after the first patient has been followed for 72 hours after receiving the first dose. Patients 4, 5, and 6 begin treatment only after patients 2 and 3 have completed 14 days of the four-part total dose. Patients are treated on an outpatient basis, with 5 to 6 days spent in the hospital for evaluation.

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00000692


Locations
United States, California
Univ of California / San Diego Treatment Ctr
San Diego, California, United States, 921036325
Stanford Univ School of Medicine
Stanford, California, United States, 94305
United States, Florida
Univ of Miami School of Medicine
Miami, Florida, United States, 331361013
United States, Illinois
Rush Presbyterian - Saint Luke's Med Ctr
Chicago, Illinois, United States, 60612
United States, Massachusetts
Harvard (Massachusetts Gen Hosp)
Boston, Massachusetts, United States, 02114
United States, South Carolina
Julio Arroyo
West Columbia, South Carolina, United States, 29169
Sponsors and Collaborators
G D Searle
National Institute of Allergy and Infectious Diseases (NIAID)
Investigators
Study Chair: MS Hirsch
  More Information

Publications:
ClinicalTrials.gov Identifier: NCT00000692     History of Changes
Other Study ID Numbers: ACTG 100
First Submitted: November 2, 1999
First Posted: August 31, 2001
Last Update Posted: March 17, 2014
Last Verified: March 2003

Keywords provided by National Institute of Allergy and Infectious Diseases (NIAID):
Acquired Immunodeficiency Syndrome
AIDS-Related Complex
Antiviral Agents
Biological Availability
1-Deoxynojirimycin

Additional relevant MeSH terms:
HIV Infections
Immunologic Deficiency Syndromes
Acquired Immunodeficiency Syndrome
AIDS-Related Complex
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immune System Diseases
Slow Virus Diseases
Miglustat
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-HIV Agents
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
Glycoside Hydrolase Inhibitors
Hypoglycemic Agents
Physiological Effects of Drugs