NCT00002373

The Safety and Effectiveness of Different Dose Levels of 1263W94 in the Treatment of Cytomegalovirus (CMV) of the Eyes in HIV-Infected Patients

A Phase I/II Trial to Evaluate the Tolerability, Anti-CMV Activity and Pharmacokinetics of 1263W94 Following Multiple Oral Administration of Escalating Doses in HIV-Infected Patients With Asymptomatic CMV Shedding

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 56 (planned)
• Sponsor: Glaxo Wellcome · Industry
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

To evaluate the safety and tolerability of multiple escalating doses of 1263W94 administered orally for 28 days in HIV infected patients with asymptomatic CMV shedding. To obtain preliminary evidence of the in vivo anti CMV activity of different doses of 1263W94 in humans based on quantitative reduction of CMV load in semen and if possible in other biological fluids and to explore the dose response relationship in the anti-CMV activity of 1263W94.

Detailed description

HIV seropositive men stratified based on CMV titer in semen at the Pre-Screen visit (30 days prior to entry). Patients with a CMV titer \>= 5000 PFU/ml and a positive result upon qualitative urine CMV culture may be eligible for entry into the main group and patients with a CMV titer \< 5000 PFU/ml may be eligible for entry into the satellite group. Patients will on 1263W94 for 4 weeks. Patients will be present for clinic visits on study days 1, 7, 14, 21, and 28. They will return to the clinic for post treatment evaluations on study days 42 and 56.

Conditions

• Cytomegalovirus Infections
• HIV Infections

Interventions

Type	Name	Description
DRUG	Maribavir

Timeline

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

Locations

2 sites across 1 country: United States