Valganciclovir in Patients With CMV Retinitis and AIDS Who Cannot Take Drugs by Injection

• Status: Unknown status
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to make valganciclovir available, before it is approved for marketing, to HIV-infected patients who have cytomegalovirus (CMV) retinitis (eye infection) and cannot take drugs by injection. This study also will look at the safety of using valganciclovir as starting and/or ongoing therapy.

CMV can cause serious AIDS-related infections in patients with HIV. Drugs that are effective against CMV eye infections can be given only by injection; this calls for a thin tube to be placed into a vein in the chest so that the patient is not put through getting too many needle sticks. An experimental drug, valganciclovir, is similar to 1 of these approved drugs, ganciclovir, but is more convenient and easier to use since it can be taken by mouth. Once in the body, valganciclovir changes to ganciclovir. Studies have shown that valganciclovir tablets can result in the same level of ganciclovir in the blood as ganciclovir injection.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Hoffmann-La Roche
• Treatments: Ganciclovir; Valganciclovir

Criteria

Inclusion Criteria

Patients may be eligible for this study if they:

• Are 18 years of age or older.

• Are HIV-positive.

• Have active CMV retinitis, shown by an eye exam by an eye doctor, that needs treatment.

• Have had problems when drugs were given by injection, such as difficulty in finding a vein or problems (blood clots, vein inflammation, or infection) caused by injection devices.

• Agree to use effective methods of birth control (i.e., barrier methods) during the study and for 90 days after taking the study drug. Females who can have children must have a negative pregnancy test before entering the study.

• Stop breast-feeding before starting the study drug.

Exclusion Criteria

Patients will not be eligible for this study if they:

• Are pregnant or breast-feeding.

• Have developed CMV retinitis after a transplant.

• Have kidney disease and need hemodialysis.

• Are taking part in another drug study, unless approved by the study doctor.

• Take experimental drugs, or have taken them within 30 days before study entry, unless approved by the study doctor.

• Take drugs not allowed on the study, including foscarnet, cidofovir, and probenecid.

• Are not able to follow study procedures, including visits to the eye doctor and the study doctor.