NCT00002183

A Phase I Trial to Evaluate the Safety, Pharmacokinetics and Antiviral Activity of 141W94 After Multiple Dosing in Patients With HIV Infection

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 60 (planned)
• Sponsor: Glaxo Wellcome · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

To assess the safety and tolerance of multiple oral doses of 141W94 alone, in combination with 1592U89, and in combination with Retrovir and Epivir, administered to patients with HIV infection as measured by the development of clinical adverse experiences and laboratory test abnormalities. To determine the steady-state pharmacokinetics of 141W94 alone and in combination with 1592U89 after multiple oral dosing. To obtain preliminary evidence of antiretroviral activity of 141W94 alone and in combination with 1592U89, the antiretroviral effect of combined Retrovir/Epivir and the antiretroviral effect of 141W94 when added to Retrovir/Epivir or to 1592U89/Retrovir/Epivir.

Detailed description

60 HIV-infected patients will be sequentially assigned to receive 1 of 5 doses of 141W94 alone or 141W94 plus 1592U89. After each patient has completed 4 weeks of the assigned regimen (Phase A), the patient will receive Epivir and Retrovir for up to 8 months (Phase B). Patients originally assigned, in Phase A, to receive 141W94 and 1592U89 continue to receive 1592U89 during this period. Upon termination of Phase B, 141W94 is added to existing regimens of Phase B (Phase C). Phase C will last for 12 weeks.

Conditions

• HIV Infections

Interventions

Type	Name	Description
DRUG	Abacavir sulfate
DRUG	Amprenavir
DRUG	Lamivudine
DRUG	Zidovudine

Timeline

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

Locations

3 sites across 1 country: United States