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

Status unconfirmed · Phase 3

Conditions studied: Cytomegalovirus Retinitis, HIV Infections

In brief

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.

Key facts

Study ID

NCT00017784

Run by

Hoffmann-La Roche

People needed

500

Last updated by the study team

2005-06-24

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Retina - Vitreous Associates Med Group — Beverly Hills, California, United States
• Wilbert Jordan — Paramount, California, United States
• Quest Clinical Research — San Francisco, California, United States
• Santa Clara Valley Med Ctr — San Jose, California, United States
• IDC Research Initiative — Altamonte Springs, Florida, United States
• Ingenix Kern McNeill Decatur — Atlanta, Georgia, United States
• Nashville Health Management Foundation / Vanderbilt Univ — Nashville, Tennessee, United States
• North Texas Infectious Disease Consultants — Dallas, Texas, United States
• Fundacion Gastroenterologia de Diego — San Juan, Puerto Rico

Full record on ClinicalTrials.gov

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