Ignite Creation Date:
2024-05-05 @ 10:17 AM
Last Modification Date:
2024-10-26 @ 9:02 AM
Study NCT ID:
NCT00000692
Status:
COMPLETED
Last Update Posted:
2005-06-24
First Post:
1999-11-02
Brief Title:
Phase I Rising Dose Tolerability Study of SC-48334 in Patients With Acquired Immunodeficiency Syndrome AIDS and Advanced AIDS Related Complex
Sponsor:
G D Searle
Organization:
National Institute of Allergy and Infectious Diseases NIAID
Study Overview
Official Title:
Phase I Rising Dose Tolerability Study of SC-48334 in Patients With Acquired Immunodeficiency Syndrome AIDS and Advanced AIDS Related Complex
Status:
COMPLETED
Status Verified Date:
2003-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 patients 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
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 patients 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
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
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 Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?: