Phase I Trial of S-1153 in Patients With HIV Infection
Completed · Phase 1
Conditions studied: HIV Infections
In brief
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.
Key facts
- Study ID
- NCT00002214
- Run by
- Lexigen Pharmaceuticals
- People needed
- 40
- Last updated by the study team
- 2005-06-24
Who can join
Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Concurrent Medication:
- 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.
You may not qualify if…
- 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:
- 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.
Where it is running
- Beth Israel Deaconess Med Ctr — Boston, Massachusetts, United States
Full record on ClinicalTrials.gov
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