Phase I Rising Dose Tolerability Study of SC-48334 in Patients With Acquired Immunodeficiency Syndrome (AIDS) and Advanced AIDS Related Complex
1 other identifier
interventional
48
1 country
6
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1 hiv-infections
6 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 2, 1999
CompletedFirst Posted
Study publicly available on registry
August 31, 2001
CompletedJune 24, 2005
March 1, 2003
November 2, 1999
June 23, 2005
Conditions
Keywords
Interventions
Eligibility Criteria
You may qualify if:
- Concurrent Medication:
- Allowed:
- Aerosolized pentamidine.
- Nystatin.
- Clotrimazole.
- Topical acyclovir.
- Concurrent Treatment:
- Allowed:
- Blood transfusions for = or \> grade 3 hemoglobin toxicity.
You may not qualify if:
- 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.
- +15 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (6)
Univ of California / San Diego Treatment Ctr
San Diego, California, 921036325, United States
Stanford Univ School of Medicine
Stanford, California, 94305, United States
Univ of Miami School of Medicine
Miami, Florida, 331361013, United States
Rush Presbyterian - Saint Luke's Med Ctr
Chicago, Illinois, 60612, United States
Harvard (Massachusetts Gen Hosp)
Boston, Massachusetts, 02114, United States
Julio Arroyo
West Columbia, South Carolina, 29169, United States
Related Publications (1)
Tierney M, Pottage J, Kessler H, Fischl M, Richman D, Merigan T, Powderly W, Smith S, Karim A, Sherman J, et al. The tolerability and pharmacokinetics of N-butyl-deoxynojirimycin in patients with advanced HIV disease (ACTG 100). The AIDS Clinical Trials Group (ACTG) of the National Institute of Allergy and Infectious Diseases. J Acquir Immune Defic Syndr Hum Retrovirol. 1995 Dec 15;10(5):549-53.
PMID: 8548334BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
MS Hirsch
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Masking
- NONE
- Purpose
- TREATMENT
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
November 2, 1999
First Posted
August 31, 2001
Last Updated
June 24, 2005
Record last verified: 2003-03