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)
Birmingham Veterans Administration Med Ctr
🇺🇸Birmingham, Alabama, United States
Los Angeles County - USC Med Ctr
🇺🇸Los Angeles, California, United States
CARE Ctr / UCLA Med Ctr
🇺🇸Los Angeles, California, United States
Highland Gen Hosp / San Francisco Gen Hosp
🇺🇸Oakland, California, United States
Univ of California / San Diego Treatment Ctr
🇺🇸San Diego, California, United States
Kaiser Permanente Med Ctr
🇺🇸San Francisco, California, United States
Univ of Colorado Health Sciences Ctr
🇺🇸Denver, Colorado, United States
Yale Univ
🇺🇸New Haven, Connecticut, United States
Northwestern Univ Med School
🇺🇸Chicago, Illinois, United States
Indiana Univ Hosp
🇺🇸Indianapolis, Indiana, United States
Scroll for more (25 remaining)Birmingham Veterans Administration Med Ctr🇺🇸Birmingham, Alabama, United States