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

Phase 1

Completed

• Conditions: HIV Infections

• Registration Number: NCT00002338
• Lead Sponsor: Glaxo Wellcome

Brief 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.

Study Timeline

• Status Verified: 1996-04
• Study First Submitted: 1999-11-02
• Study First Submitted QC: 2001-08-30
• Study First Posted: 2001-08-31
• Last Update Submitted: 2005-06-23
• Last Update Posted: 2005-06-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: Not specified

Trial Locations

Locations (7)

ViRx Inc; 🇺🇸 San Francisco, California, United States

Georgetown Univ Med Ctr; 🇺🇸 Washington, District of Columbia, United States

Goodgame Med Group; 🇺🇸 Maitland, Florida, United States

Indiana Univ Hosp; 🇺🇸 Indianapolis, Indiana, United States

Duke Univ Med Ctr; 🇺🇸 Durham, North Carolina, United States

Univ of Cincinnati / Holmes Hosp; 🇺🇸 Cincinnati, Ohio, United States

Univ of Pittsburgh Med School; 🇺🇸 Pittsburgh, Pennsylvania, United States