NCT00002338

The Safety and Effectiveness of 935U83 in HIV-Infected Patients

A Phase I Trial to Evaluate the Safety, Tolerance, and Pharmacokinetics of 935U83 After Multiple Dosing in Patients With HIV Infection

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 40 (planned)
• Sponsor: Glaxo Wellcome · Industry
• Sex: All
• Age: 13 Years
• Healthy volunteers: Not accepted

Summary

To assess the safety, tolerance, and steady-state pharmacokinetics of multiple oral doses of 935U83 administered to patients with HIV infection. To obtain preliminary evidence of antiretroviral activity of 935U83. To prospectively evaluate the emergence of in vitro drug resistance. To determine the effects of 935U83 dosing on CD4+ cell counts.

Detailed description

Patients (10 per dose level) are randomized to receive 1 of 4 doses of 935U83 every 8 hours for 12 weeks. Five patients at each dose level must complete 4 weeks of treatment without serious toxicity before subsequent patients are entered at the next higher dose. If lack of antiretroviral effect or unacceptable toxicity is demonstrated at a particular dose level, the dose regimens may be adjusted.

Conditions

• HIV Infections

Interventions

Type	Name	Description
DRUG	Raluridine

Timeline

• First posted: 2001-08-31
• Last updated: 2005-06-24

Locations

7 sites across 1 country: United States