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

Phase 1

Completed

• Conditions: HIV Infections

• Registration Number: NCT00002214
• Lead Sponsor: Lexigen Pharmaceuticals

Brief 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.

Detailed 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 Timeline

• Status Verified: 1998-07
• Study First Submitted: 1999-11-02
• Study First Submitted QC: 2001-08-30
• Study First Posted: 2001-08-31
• Last Update Submitted: 2005-06-23
• Last Update Posted: 2005-06-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: Not specified

Trial Locations

Locations (1)

Beth Israel Deaconess Med Ctr; 🇺🇸 Boston, Massachusetts, United States