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Antiviral
Valganciclovir for Cytomegalovirus Retinitis
Phase 3
Waitlist Available
Research Sponsored by Hoffmann-La Roche
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Females who can have children must have a negative pregnancy test before entering the study
Patients must have active CMV retinitis that needs treatment
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
Study Summary
This trial will study whether valganciclovir is effective and safe in treating CMV retinitis in patients with AIDS who cannot take drugs by injection.
Who is the study for?
This trial is for adults over 18 with HIV and active CMV retinitis, who have had issues with injectable medications. They must not be on dialysis, involved in other drug studies, or have taken experimental drugs recently. Participants need to use birth control and cannot be pregnant or breastfeeding.Check my eligibility
What is being tested?
The study provides access to valganciclovir, an oral medication still under review, as a treatment for CMV retinitis in HIV patients. It's being tested for safety and effectiveness as an alternative to injectable treatments.See study design
What are the potential side effects?
While the specific side effects are not listed here, similar drugs can cause digestive problems, blood cell changes, potential kidney issues and may interact with other medications.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am a woman who can have children and have a negative pregnancy test.
Select...
I need treatment for active CMV retinitis.
Select...
I am 18 years old or older.
Select...
I have experienced issues with receiving injections.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
Treatment Details
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Who is running the clinical trial?
Hoffmann-La RocheLead Sponsor
2,431 Previous Clinical Trials
1,089,568 Total Patients Enrolled
13 Trials studying Cytomegalovirus Retinitis
1,833 Patients Enrolled for Cytomegalovirus Retinitis
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have not had CMV retinitis after a transplant.I am not taking any medications that are not allowed in the study.I am a woman who can have children and have a negative pregnancy test.I need treatment for active CMV retinitis.I am 18 years old or older.I have experienced issues with receiving injections.I do not require hemodialysis for kidney disease.
Research Study Groups:
This trial has the following groups:Awards:
This trial has 2 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Could I join the ranks of this trial?
"Eligible patients for this clinical study must have a diagnosis of cytomegalovirus retinitis and be between the ages of 18 and 65. Up to 500 participants will be accepted into the trial."
Answered by AI
Would this clinical trial be appropriate for individuals who are over the age of 50?
"This study is recruiting people who are above 18 years old and less than 65 years old."
Answered by AI
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