Phase I Rising Dose Tolerability Study of SC-48334 in Patients With Acquired Immunodeficiency Syndrome (AIDS) and Advanced AIDS Related Complex
Completed · Phase 1
Conditions studied: HIV Infections
In brief
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.
Key facts
- Study ID
- NCT00000692
- Run by
- G D Searle
- People needed
- 48
- Last updated by the study team
- 2005-06-24
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
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.
- 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:
Where it is running
- Univ of California / San Diego Treatment Ctr — San Diego, California, United States
- Stanford Univ School of Medicine — Stanford, California, United States
- Univ of Miami School of Medicine — Miami, Florida, United States
- Rush Presbyterian - Saint Luke's Med Ctr — Chicago, Illinois, United States
- Harvard (Massachusetts Gen Hosp) — Boston, Massachusetts, United States
- Julio Arroyo — West Columbia, South Carolina, United States
Full record on ClinicalTrials.gov
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