Ignite Creation Date:
2024-05-05 @ 11:21 AM
Last Modification Date:
2024-10-26 @ 9:02 AM
Study NCT ID:
NCT00001038
Status:
COMPLETED
Last Update Posted:
2011-03-01
First Post:
1999-11-02
Brief Title:
A Study of Valacyclovir Hydrochloride in the Prevention of Life-Threatening Cytomegalovirus Disease in HIV-Infected Patients
Sponsor:
National Institute of Allergy and Infectious Diseases NIAID
Organization:
National Institute of Allergy and Infectious Diseases NIAID
Study Overview
Official Title:
A Randomized Double-Blind Trial of Valacyclovir Hydrochloride BW 256U87 Prophylaxis for Opportunistic Cytomegalovirus End-Organ Disease in Patients With Advanced HIV Infection 100 CD4 Lymphocytes
Status:
COMPLETED
Status Verified Date:
2011-02
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:
PRIMARY To evaluate the efficacy of valacyclovir hydrochloride BW 256U87 in the prevention of cytomegalovirus CMV end-organ disease in HIVCMV co-infected patients with CD4 lymphocytes 100 cellsmm3 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
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
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
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| FDA 104C | None | None | None |