A Study of Valacyclovir Hydrochloride in the Prevention of Life-Threatening Cytomegalovirus Disease in HIV-Infected Patients
- Conditions
- Cytomegalovirus InfectionsHIV Infections
- Registration Number
- NCT00001038
- Brief Summary
PRIMARY: To evaluate the efficacy of valacyclovir hydrochloride (BW 256U87) in the prevention of cytomegalovirus (CMV) end-organ disease in HIV/CMV co-infected patients with CD4+ lymphocytes \< 100 cells/mm3. To assess the impact of BW 256U87, high-dose oral acyclovir and low-dose oral acyclovir on survival.
SECONDARY: To evaluate the effect of BW 256U87 on quality of life, the safety of the drug administered concurrently with standard antiretroviral agents and other essential therapies for the treatment and prevention of opportunistic diseases, and the efficacy of BW 256U87 in suppressing activation of other herpesviruses. To evaluate serologic and virologic risk factors for the development of CMV disease, including assessment of HIV activation, and the risk of developing drug-resistant CMV, HSV, and VZV.
Gastrointestinal absorption of acyclovir is not high enough to prevent CMV disease in patients with advanced HIV disease, although there is evidence that high doses of the drug may extend survival. Valacyclovir, a prodrug that is rapidly converted to acyclovir after oral administration, has a higher absorption rate and may therefore provide inhibitory activity against CMV.
- Detailed Description
Gastrointestinal absorption of acyclovir is not high enough to prevent CMV disease in patients with advanced HIV disease, although there is evidence that high doses of the drug may extend survival. Valacyclovir, a prodrug that is rapidly converted to acyclovir after oral administration, has a higher absorption rate and may therefore provide inhibitory activity against CMV.
Patients are randomized to receive BW 256U87 alone or acyclovir alone as control at either high-dose or low-dose. The acyclovir controls will provide suppressive therapy for herpes simplex infections and may affect survival.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 1200
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 (35)
Montreal Chest Institute
🇨🇦Montreal, Quebec, Canada
Southern Alberta HIV Clinic / Foothills Hosp
🇨🇦Calgary, Alberta, Canada
Yale Univ
🇺🇸New Haven, Connecticut, United States
Montreal Gen Hosp
🇨🇦Montreal, Quebec, Canada
Medizinische Universibatspoliklinik Infekbiologie
🇨🇭Bern, Switzerland
CARE Ctr / UCLA Med Ctr
🇺🇸Los Angeles, California, United States
Birmingham Veterans Administration Med Ctr
🇺🇸Birmingham, Alabama, United States
Universita Cattolica del Sacro Cuore
🇮🇹Rome, Italy
Washington Univ
🇺🇸St Louis, Missouri, United States
Highland Gen Hosp / San Francisco Gen Hosp
🇺🇸Oakland, California, United States
Indiana Univ Hosp
🇺🇸Indianapolis, Indiana, United States
Universitatsklinikum Rudolf Virchow
🇩🇪Berlin, Germany
Univ of California / San Diego Treatment Ctr
🇺🇸San Diego, California, United States
Northwestern Univ Med School
🇺🇸Chicago, Illinois, United States
Kaiser Permanente Med Ctr
🇺🇸San Francisco, California, United States
Univ of Colorado Health Sciences Ctr
🇺🇸Denver, Colorado, United States
Mount Sinai Med Ctr
🇺🇸New York, New York, United States
Harvard (Massachusetts Gen Hosp)
🇺🇸Boston, Massachusetts, United States
Ohio State Univ Hosp Clinic
🇺🇸Columbus, Ohio, United States
Girard Med Ctr
🇺🇸Philadelphia, Pennsylvania, United States
Univ TX Galveston Med Branch
🇺🇸Galveston, Texas, United States
Sunnybrook Health Science Ctr
🇨🇦Toronto, Ontario, Canada
Saint Vincent's Hosp Med Centre
🇦🇺Sydney, Australia
Toronto Hosp
🇨🇦Toronto, Ontario, Canada
Hvidovre Univ Hosp
🇩🇰Hvidore, Denmark
South Hosp
🇸🇪Stockholm, Sweden
Services des Maladies Infectieuses
🇫🇷Paris Cedex 12, France
Univ of Washington / Madison Clinic
🇺🇸Seattle, Washington, United States
Westminster Hosp
🇬🇧London, United Kingdom
Los Angeles County - USC Med Ctr
🇺🇸Los Angeles, California, United States
Univ of North Carolina School of Medicine
🇺🇸Chapel Hill, North Carolina, United States
Royal Free Hosp
🇬🇧London, United Kingdom
Johns Hopkins Hosp
🇺🇸Baltimore, Maryland, United States
Boston Med Ctr
🇺🇸Boston, Massachusetts, United States
North Central Bronx Hosp / Bronx Municipal Hosp
🇺🇸Bronx, New York, United States