Preventing Cytomegalovirus (CMV) Organ Damage With Valganciclovir in People With HIV
- Conditions
- Cytomegalovirus InfectionsHIV Infections
- Registration Number
- NCT00006145
- 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 cells/mm3 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 3.0 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 350
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (57)
Alabama Therapeutics CRS
🇺🇸Birmingham, Alabama, United States
USC CRS
🇺🇸Los Angeles, California, United States
UCLA CARE Center CRS
🇺🇸Los Angeles, California, United States
Stanford CRS
🇺🇸Palo Alto, California, United States
Ucsd, Avrc Crs
🇺🇸San Diego, California, United States
Ucsf Aids Crs
🇺🇸San Francisco, California, United States
Santa Clara Valley Med. Ctr.
🇺🇸San Jose, California, United States
San Mateo County AIDS Program
🇺🇸San Mateo, California, United States
Marin County Dept. of Health & Human Services, HIV/AIDS Program & Specialty Clinic
🇺🇸San Rafael, California, United States
University of Colorado Hospital CRS
🇺🇸Aurora, Colorado, United States
Scroll for more (47 remaining)Alabama Therapeutics CRS🇺🇸Birmingham, Alabama, United States