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)
Cook County Hosp. CORE Ctr.
🇺🇸Chicago, Illinois, United States
IHV Baltimore Treatment CRS
🇺🇸Baltimore, Maryland, United States
Johns Hopkins Adult AIDS CRS
🇺🇸Baltimore, Maryland, United States
Hosp. of the Univ. of Pennsylvania CRS
🇺🇸Philadelphia, Pennsylvania, United States
Pitt CRS
🇺🇸Pittsburgh, Pennsylvania, United States
USC CRS
🇺🇸Los Angeles, California, United States
Stanford CRS
🇺🇸Palo Alto, California, United States
Santa Clara Valley Med. Ctr.
🇺🇸San Jose, California, United States
Georgetown University CRS (GU CRS)
🇺🇸Washington, District of Columbia, United States
Univ. of Hawaii at Manoa, Leahi Hosp.
🇺🇸Honolulu, Hawaii, United States
UCLA CARE Center CRS
🇺🇸Los Angeles, California, United States
Marin County Dept. of Health & Human Services, HIV/AIDS Program & Specialty Clinic
🇺🇸San Rafael, California, United States
Alabama Therapeutics CRS
🇺🇸Birmingham, Alabama, United States
Ucsf Aids Crs
🇺🇸San Francisco, California, United States
The Ponce de Leon Ctr. CRS
🇺🇸Atlanta, Georgia, United States
Univ. of Iowa Healthcare, Div. of Infectious Diseases
🇺🇸Iowa City, Iowa, United States
Rush Univ. Med. Ctr. ACTG CRS
🇺🇸Chicago, Illinois, United States
Univ. of Texas Medical Branch, ACTU
🇺🇸Galveston, Texas, United States
Massachusetts General Hospital ACTG CRS
🇺🇸Boston, Massachusetts, United States
BMC, Div. of Ped Infectious Diseases
🇺🇸Boston, Massachusetts, United States
Beth Israel Deaconess Med. Ctr., ACTG CRS
🇺🇸Boston, Massachusetts, United States
Brigham and Women's Hosp. ACTG CRS
🇺🇸Boston, Massachusetts, United States
Case CRS
🇺🇸Cleveland, Ohio, United States
Cleveland Clinic Foundation, Div. of Medicine, Infectious Diseases
🇺🇸Cleveland, Ohio, United States
Ucsd, Avrc Crs
🇺🇸San Diego, California, United States
Univ. of Miami AIDS CRS
🇺🇸Miami, Florida, United States
Indiana Univ. School of Medicine, Wishard Memorial
🇺🇸Indianapolis, Indiana, United States
Methodist Hosp. of Indiana
🇺🇸Indianapolis, Indiana, United States
University of Minnesota, ACTU
🇺🇸Minneapolis, Minnesota, United States
Univ. of Cincinnati CRS
🇺🇸Cincinnati, Ohio, United States
University of Washington AIDS CRS
🇺🇸Seattle, Washington, United States
AIDS Care CRS
🇺🇸Rochester, New York, United States
Univ. of Rochester ACTG CRS
🇺🇸Rochester, New York, United States
University of Colorado Hospital CRS
🇺🇸Aurora, Colorado, United States
San Mateo County AIDS Program
🇺🇸San Mateo, California, United States
Northwestern University CRS
🇺🇸Chicago, Illinois, United States
Indiana Univ. School of Medicine, Infectious Disease Research Clinic
🇺🇸Indianapolis, Indiana, United States
Bmc Actg Crs
🇺🇸Boston, Massachusetts, United States
Washington U CRS
🇺🇸Saint Louis, Missouri, United States
SSTAR, Family Healthcare Ctr.
🇺🇸Fall River, Massachusetts, United States
Univ. of Nebraska Med. Ctr., Durham Outpatient Ctr.
🇺🇸Omaha, Nebraska, United States
Beth Israel Med. Ctr., ACTU
🇺🇸New York, New York, United States
SUNY - Buffalo, Erie County Medical Ctr.
🇺🇸Buffalo, New York, United States
Columbia Univ., HIV Prevention and Treatment Medical Ctr.
🇺🇸New York, New York, United States
NY Univ. HIV/AIDS CRS
🇺🇸New York, New York, United States
Weill Med. College of Cornell Univ., The Cornell CTU
🇺🇸New York, New York, United States
Cornell CRS
🇺🇸New York, New York, United States
McCree McCuller Wellness Ctr. at the Connection, Infectious Disease Unit
🇺🇸Rochester, New York, United States
Unc Aids Crs
🇺🇸Chapel Hill, North Carolina, United States
MetroHealth CRS
🇺🇸Cleveland, Ohio, United States
The Ohio State University Medical Center
🇺🇸Columbus, Ohio, United States
Univ. of Pennsylvania Health System, Presbyterian Med. Ctr.
🇺🇸Philadelphia, Pennsylvania, United States
The Miriam Hosp. ACTG CRS
🇺🇸Providence, Rhode Island, United States
Rhode Island Hosp.
🇺🇸Providence, Rhode Island, United States
Univ. of Texas Southwestern Med. Ctr., Amelia Court Continuity Clinic
🇺🇸Dallas, Texas, United States
Vanderbilt Therapeutics CRS
🇺🇸Nashville, Tennessee, United States
Puerto Rico-AIDS CRS
🇵🇷San Juan, Puerto Rico