Ignite Creation Date:
2024-05-05 @ 11:19 AM
Last Modification Date:
2024-10-26 @ 9:05 AM
Study NCT ID:
NCT00006145
Status:
COMPLETED
Last Update Posted:
2021-11-01
First Post:
2000-08-07
Brief Title:
Preventing Cytomegalovirus CMV Organ Damage With Valganciclovir in People With HIV
Sponsor:
National Institute of Allergy and Infectious Diseases NIAID
Organization:
National Institute of Allergy and Infectious Diseases NIAID
Study Overview
Official Title:
A Phase III Prospective Randomized Double-Blind Trial of Valganciclovir Pre-Emptive Therapy for Cytomegalovirus CMV Viremia as Detected by Plasma CMV DNA PCR Assay
Status:
COMPLETED
Status Verified Date:
2021-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Cytomegalovirus CMV infection is a common opportunistic infection OI in HIV patients The purpose of this study is to find out whether valganciclovir an antiviral approved by the FDA for the treatment of CMV in the eye is safe and effective in preventing CMV organ damage in people with HIV
Detailed Description:
CMV infection most commonly of the retina also known as CMV retinitis is a common OI observed in HIV patients Despite treatment CMV retinitis can result in severe visual impairment and CMV disease is associated with reduced survival time HIV patients receiving highly active antiretroviral therapy HAART for HIV infection who have CD4 counts less than 100 cellsmm3 may be at increased risk of CMV infection and its complications Valganciclovir was approved by the FDA on March 29 2001 for treatment of the symptoms of CMV retinitis in patients with weakened immune systems including people with HIV and AIDS This study will evaluate the safety and efficacy of valganciclovir in preventing CMV organ damage in HIV patients
This study will last approximately 6 years Step 1 is the longitudinal screening phase of the study Patients at high risk for CMV disease who are enrolled in the study will be screened every 8 weeks for CMV in the blood medical history assessment physical examination and blood work will occur at each visit Additional blood collection to monitor HIV infection will occur every 16 weeks Patients will undergo opthalmologic examination every 24 weeks Patients who develop detectable CMV in their blood during Step 1 then enter Step 2 of the study
In version 30 of this study participants who test positive for CMV viremia or who are currently in Step 2 will be automatically enrolled into Step 4 and will be randomly assigned to one of two groups 1 900 mg valganciclovir twice daily for 3 weeks followed by 900 mg valganciclovir daily or 2 placebo Participants will enter Step 3 if and when they develop CMV end-organ disease at which point all participants will be offered 900 mg valganciclovir twice daily for 3 weeks then 900 valganciclovir daily thereafter
This study will last approximately 6 years Step 1 is the longitudinal screening phase of the study Patients at high risk for CMV disease who are enrolled in the study will be screened every 8 weeks for CMV in the blood medical history assessment physical examination and blood work will occur at each visit Additional blood collection to monitor HIV infection will occur every 16 weeks Patients will undergo opthalmologic examination every 24 weeks Patients who develop detectable CMV in their blood during Step 1 then enter Step 2 of the study
In version 30 of this study participants who test positive for CMV viremia or who are currently in Step 2 will be automatically enrolled into Step 4 and will be randomly assigned to one of two groups 1 900 mg valganciclovir twice daily for 3 weeks followed by 900 mg valganciclovir daily or 2 placebo Participants will enter Step 3 if and when they develop CMV end-organ disease at which point all participants will be offered 900 mg valganciclovir twice daily for 3 weeks then 900 valganciclovir daily thereafter
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| AACTG A5030 | Registry Identifier | DAIDS ES | None |
| 10170 | REGISTRY | None | None |
| ACTG A5030 | None | None | None |