NCT00002437

The Safety and Effectiveness of Cidofovir in the Treatment of Cytomegalovirus (CMV) of the Eyes in Patients With AIDS

A Phase II/III Study of the Safety and Efficacy of 1-(S)-(3-Hydroxy-2-Phosphonylmethoxypropyl)Cytosine Dihydrate (Cidofovir; HPMPC) for the Treatment of Peripheral Cytomegalovirus Retinitis in Patients With AIDS

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 48 (planned)
• Sponsor: Gilead Sciences · Industry
• Sex: All
• Age: 13 Years – 60 Years
• Healthy volunteers: Not accepted

Summary

To determine whether cidofovir (HPMPC) therapy administered by intravenous infusion can extend the time to progression of peripheral cytomegalovirus (CMV) retinitis in AIDS patients. To evaluate the safety and tolerance of HPMPC therapy when administered by intravenous infusion in AIDS patients with CMV retinitis that is not immediately sight-threatening. To evaluate the virologic effects of intravenous HPMPC therapy on CMV shedding in urine, blood, and/or semen. To evaluate the impact of HPMPC therapy on visual acuity.

Detailed description

Patients are randomized to one of two treatment arms. Group A receives HPMPC by IV infusion weekly for 2 consecutive weeks (induction) and then every other week (maintenance) with oral probenecid and IV hydration. Group B receives no treatment until the time of retinitis progression (deferred treatment), at which time they receive the same regimen as Group A, provided retinitis progression is not immediately sight-threatening.

Conditions

• Cytomegalovirus Retinitis
• HIV Infections

Interventions

Type	Name	Description
DRUG	Cidofovir
DRUG	Probenecid

Timeline

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

Locations

9 sites across 2 countries: United States, United Kingdom