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

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: G D Searle
• Collaborator: National Institute of Allergy and Infectious Diseases (NIAID)
• Treatments: Miglustat

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.