A Comparison of Valganciclovir and Ganciclovir in the Treatment of Cytomegalovirus (CMV) of the Eyes

Roche

Status and phase: Completed; Phase 3

Conditions: Cytomegalovirus Retinitis; HIV Infections

Treatments: Drug: Ganciclovir; Drug: Valganciclovir

Study type: Interventional

Funder types: Industry

Identifiers

NCT00002377

WV15376

Details and patient eligibility

About

To investigate the efficacy and safety of RS-79070 when used as induction therapy in patients with newly diagnosed peripheral retinitis. To assess the effects of induction and maintenance level dosing of RS-79070 on CMV viral load, estimated by plasma CMV PCR. To assess the pharmacokinetics of ganciclovir following administration of RS-79070 in the target population.

Sex: All

Ages: 14+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:

• Documented AIDS diagnosis
• Newly diagnosed peripheral CMV retinitis
• More than 3 weeks of previous therapy for CMV retinitis