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Sponsored by: |
Lexigen Pharmaceuticals |
Information provided by: | NIH AIDS Clinical Trials Information Service |
ClinicalTrials.gov Identifier: | NCT00002214 |
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.
Condition | Intervention | Phase |
HIV Infections |
Drug: Capravirine |
Phase I |
MedlinePlus related topics: | AIDS |
ChemIDplus related topics: | Capravirine |
Study Type: | Interventional |
Study Design: | Treatment, Dose Comparison, Pharmacokinetics Study |
Official Title: | Phase I Trial of S-1153 in Patients With HIV Infection |
Estimated Enrollment: | 40 |
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.
Ages Eligible for Study: | 18 Years to 70 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria
Concurrent Medication:
1. Required for patients with CD4 cell count lower than 200:
Patients must have:
Prior Medication:
Allowed for entry onto multiple-dose study:
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.
Prior Treatment:
Excluded within 3 weeks prior to study entry:
Study ID Numbers: | 286A, 9616T0311, 51,197 |
First Received: | November 2, 1999 |
Last Updated: | June 23, 2005 |
ClinicalTrials.gov Identifier: | NCT00002214 |
Health Authority: | United States: Food and Drug Administration |
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