- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00000692
Phase I Rising Dose Tolerability Study of SC-48334 in Patients With Acquired Immunodeficiency Syndrome (AIDS) and Advanced AIDS Related Complex
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.
Study Overview
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.
Study Type
Enrollment
Phase
- Phase 1
Contacts and Locations
Study Locations
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California
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San Diego, California, United States, 921036325
- Univ of California / San Diego Treatment Ctr
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Stanford, California, United States, 94305
- Stanford Univ School of Medicine
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Florida
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Miami, Florida, United States, 331361013
- Univ of Miami School of Medicine
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Illinois
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Chicago, Illinois, United States, 60612
- Rush Presbyterian - Saint Luke's Med Ctr
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Massachusetts
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Boston, Massachusetts, United States, 02114
- Harvard (Massachusetts Gen Hosp)
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South Carolina
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West Columbia, South Carolina, United States, 29169
- Julio Arroyo
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Masking: None (Open Label)
Collaborators and Investigators
Sponsor
Investigators
- Study Chair: MS Hirsch
Publications and helpful links
Study record dates
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- RNA Virus Infections
- Virus Diseases
- Infections
- Blood-Borne Infections
- Communicable Diseases
- Sexually Transmitted Diseases, Viral
- Sexually Transmitted Diseases
- Lentivirus Infections
- Retroviridae Infections
- Immune System Diseases
- Slow Virus Diseases
- HIV Infections
- Acquired Immunodeficiency Syndrome
- Immunologic Deficiency Syndromes
- AIDS-Related Complex
- Hypoglycemic Agents
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Anti-Infective Agents
- Antiviral Agents
- Enzyme Inhibitors
- Anti-HIV Agents
- Anti-Retroviral Agents
- Glycoside Hydrolase Inhibitors
- Miglustat
Other Study ID Numbers
- ACTG 100
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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