Valganciclovir in Patients With CMV Retinitis and AIDS Who Cannot Take Drugs by Injection
Open-Label Safety Study of Valganciclovir in Patients With CMV Retinitis and AIDS Who Have Complications Due to IV Treatment
2 other identifiers
interventional
500
2 countries
9
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
9 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 11, 2001
CompletedFirst Posted
Study publicly available on registry
August 31, 2001
CompletedJune 24, 2005
June 1, 2001
June 11, 2001
June 23, 2005
Conditions
Keywords
Interventions
Eligibility Criteria
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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (9)
Retina - Vitreous Associates Med Group
Beverly Hills, California, 90211, United States
Wilbert Jordan
Paramount, California, 90723, United States
Quest Clinical Research
San Francisco, California, 94115, United States
Santa Clara Valley Med Ctr
San Jose, California, 95128, United States
IDC Research Initiative
Altamonte Springs, Florida, 32701, United States
Ingenix Kern McNeill Decatur
Atlanta, Georgia, 30309, United States
Nashville Health Management Foundation / Vanderbilt Univ
Nashville, Tennessee, 37203, United States
North Texas Infectious Disease Consultants
Dallas, Texas, 75246, United States
Fundacion Gastroenterologia de Diego
San Juan, 00909, Puerto Rico