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

Launched by LEXIGEN PHARMACEUTICALS · Aug 30, 2001

Keywords

ClinConnect Summary

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. ...

Gender

ALL

Eligibility criteria

• • Inclusion Criteria
• Concurrent Medication:
• 1. Required for patients with CD4 cell count lower than 200:
• • PCP prophylaxis with aerosolized pentamidine, trimethoprim/sulfamethoxazole, mepron, or dapsone.
• * Allowed:
• • Continuation on an approved antiretroviral agent other than non-nucleoside reverse transcriptase inhibitors (e.g., Nevirapine) or other specifically excluded prior medications, if received without complications for at least 4 weeks prior to study entry.
• Patients must have:
• • Serologically documented HIV infection.
• * Single-dose patients:
• * CD4 cell count greater than 50 (no upper limit for single-dose cohorts). Repeated-dose patients:
• • CD4 count from 50 to 500 within 35 days prior to entrance on study.
• • No active opportunistic infection.
• Prior Medication:
• Allowed for entry onto multiple-dose study:
• • Single-dose portion of S-1153 study, provided all study visits and evaluations are completed, all eligibility criteria are met, and a minimum of 30 days has elapsed before Day 1 of the repeated-dose administration.
• • Exclusion Criteria
• Co-existing Condition:
• Patients with the following symptoms or conditions are excluded:
• • Active opportunistic infection.
• Concurrent Medication:
• Excluded:
• • Concomitant use (within 5 half-lives prior to administration and for at least 24 hours following cessation of treatment with S-1153) of highly plasma-bound drugs with narrow therapeutic indices, including but not limited to coumadin and dilantin.
• Prior Medication:
• • 1. Investigational new drugs.
• * Excluded within 30 days prior to study entry:
• • Chronic (greater than 7 days) use of drugs known to affect or be extensively metabolized by cytochromes P450, including but not limited to ketoconazole, fluconazole, itraconazole, isoniazid, rifampin, rifabutin, astemizole, terfenadine, or protease inhibitors.
• Prior Treatment:
• Excluded within 3 weeks prior to study entry:
• • Cytotoxic chemotherapy.
• • Interferon treatment.
• • Radiation therapy.