Phase I Trial of S-1153 in Patients With HIV Infection

HIV Infections Clinical Trial

Official title: Phase I Trial of S-1153 in Patients With HIV Infection

Status Completed

Clinical Trial Summary

To assess the toxicity profile and determine the maximum tolerated dose (MTD), if possible, of S-1153 administered orally 3 times daily for 14 days. To investigate the clinical pharmacokinetic parameters for S-1153. To assess anti-HIV activity associated with S-1153 administration through evaluation of CD4 and viral load measurements.

Clinical Trial Description

Two separate schedules of S-1153 are administered on this study: single dose (2 dose levels/cohorts) and repeated dose administration over 14 days (escalation through 4 dose levels/cohorts). All doses are determined by body weight.

Single-dose study (Cohort 1):

(4 patients) low-dose po, following a standardized morning meal. (4 patients) low-dose po, fasting.

Single-dose study (Cohort 2), administered during the first 3 levels of the repeated dose study and prior to the initiation of the 4th repeated dose level:

(4 patients): intermediate-dose po, following a standardized morning meal. (4 patients):

intermediate-dose po, fasted. Following treatment with S-1153, all single-dose patients (Cohorts 1and 2) are observed for 21 days.

Repeated dose (escalation) study:

All doses are administered for 14 days. Three patients are entered at the starting dose of S-1153. In the absence of dose-limiting toxicity (DLT), subsequent 3-patient cohorts are entered at 3 escalating doses.

The last patient at any given dose level must be observed for 21 days prior to entry of patient at the next dose. If 1 of the initial 3 patients experiences DLT at a given level, 3 additional patients will be added at that dose; if no additional toxicity occurs, escalation resumes. If 2 or more patients at a given dose exhibit DLT, the previous dose is declared the maximum tolerated dose (MTD) and 3 additional patients (6 total) are treated at that dose. ;

Study Design

Endpoint Classification: Pharmacokinetics Study, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Acquired Immunodeficiency Syndrome
• HIV Infections
• Infection

• NCT number: NCT00002214
• Study type: Interventional
• Source: NIH AIDS Clinical Trials Information Service
• Status: Completed
• Phase: Phase 1