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

NCT00002214 | Completed Phase 1

• 3 other identifiers: 286A9616T031151,197
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

HIV Infections

Keywords

Dose-Response Relationship, Drug; Reverse Transcriptase Inhibitors

Interventions

Capravirine DRUG

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• Lexigen Pharmaceuticals: lead

Study Sites (1)

Beth Israel Deaconess Med Ctr

Boston, Massachusetts, 02215, United States

Location

MeSH Terms

Conditions

HIV Infections

Interventions

capravirine

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Study Design

• Study Type: interventional
• Phase: phase 1
• Purpose: TREATMENT
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: November 2, 1999
• First Posted: August 31, 2001
• Last Updated: June 24, 2005

Record last verified: 1998-07

Locations

US (1)