Ignite Creation Date:
2024-05-05 @ 1:18 AM
Last Modification Date:
2024-10-26 @ 9:02 AM
Study NCT ID:
NCT00001082
Status:
COMPLETED
Last Update Posted:
2013-10-01
First Post:
1999-11-02
Brief Title:
The Safety and Effectiveness of Adefovir Dipivoxil in the Treatment of 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 Phase III Randomized Double-Blind Placebo-Controlled Study of the Safety and Efficacy of Adefovir Dipivoxil Bis-POM PMEA in Prolonging Survival of HIV-Infected Individuals With a CD4 Cell Count of 100mm3 or With a CD4 Cell Count Both 100 and 200mm3 and a Nadir CD4 Cell Count of 50mm3
Status:
COMPLETED
Status Verified Date:
2013-09
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:
To evaluate the safety and efficacy of adefovir dipivoxil in prolonging survival of patients with advanced HIV disease In CMV prophylaxis substudy To evaluate the efficacy of adefovir dipivoxil in preventing the development of CMV end-organ disease in patients with advanced HIV coinfected with CMV
The optimal treatment for HIV infection and the prevention of CMV disease has not been identified Currently available antiretroviral therapies are hampered by both significant toxicities and the development of resistance In addition agents for preventing CMV disease such as oral ganciclovir are complicated by poor bioavailability and decreased compliance secondary to toxicities Moreover discordant results have been reported regarding the effectiveness of oral ganciclovir for preventing CMV disease There is a need for newer agents with anti-HIV and anti-herpesvirus activity that have good pharmacokinetic and safety profiles and that will be well tolerated by patients Adefovir dipivoxil is an oral pro-drug of PMEA a nucleoside analog with activity against a broad spectrum of retroviruses and herpesviruses including important human pathogens such as HIV-1 HIV-2 and CMV Due to its anti-HIV and anti-herpesvirus activity adefovir dipivoxil may be able to decrease the incidence of opportunistic herpesvirus infections and prolong survival in patients with advanced HIV infection
The optimal treatment for HIV infection and the prevention of CMV disease has not been identified Currently available antiretroviral therapies are hampered by both significant toxicities and the development of resistance In addition agents for preventing CMV disease such as oral ganciclovir are complicated by poor bioavailability and decreased compliance secondary to toxicities Moreover discordant results have been reported regarding the effectiveness of oral ganciclovir for preventing CMV disease There is a need for newer agents with anti-HIV and anti-herpesvirus activity that have good pharmacokinetic and safety profiles and that will be well tolerated by patients Adefovir dipivoxil is an oral pro-drug of PMEA a nucleoside analog with activity against a broad spectrum of retroviruses and herpesviruses including important human pathogens such as HIV-1 HIV-2 and CMV Due to its anti-HIV and anti-herpesvirus activity adefovir dipivoxil may be able to decrease the incidence of opportunistic herpesvirus infections and prolong survival in patients with advanced HIV infection
Detailed Description:
The optimal treatment for HIV infection and the prevention of CMV disease has not been identified Currently available antiretroviral therapies are hampered by both significant toxicities and the development of resistance In addition agents for preventing CMV disease such as oral ganciclovir are complicated by poor bioavailability and decreased compliance secondary to toxicities Moreover discordant results have been reported regarding the effectiveness of oral ganciclovir for preventing CMV disease There is a need for newer agents with anti-HIV and anti-herpesvirus activity that have good pharmacokinetic and safety profiles and that will be well tolerated by patients Adefovir dipivoxil is an oral pro-drug of PMEA a nucleoside analog with activity against a broad spectrum of retroviruses and herpesviruses including important human pathogens such as HIV-1 HIV-2 and CMV Due to its anti-HIV and anti-herpesvirus activity adefovir dipivoxil may be able to decrease the incidence of opportunistic herpesvirus infections and prolong survival in patients with advanced HIV infection
All patients will be enrolled within the first 18 months of the study They will be randomized to 1 of 2 groups Group 1 will be comprised of 1080 patients and will receive adefovir dipivoxil plus L-carnitine and group 2 will be comprised of 1080 patients and will receive a placebo plus L-carnitine At least the first 400 patients enrolled 200 in each group will comprise the safety-HIV virology cohort These patients will have more frequent follow up visits additional laboratory evaluations and more intensive safety data information during the first 6 months NOTE At least 850 patients who are infected with CMV are followed for the development of CMV end-organ disease in a CMV prophylaxis substudy
AS PER AMENDMENT 8797 All patients are enrolled in the primary study and randomized to the treatment or placebo regimen Within the primary study patients meeting specified criteria may be enrolled in one or more of the following cohorts
1 Safety-HIV virology cohort at least the first 400 patients enrolled in the study regardless of CMV status
2 CMV bDNA cohort those patients in the safety-HIV virology cohort who are CMV-positive
3 CMV-virology cohort the first 400 patients in the CMV bDNA cohort enrolled at sites able to obtain CMV urine cultures
All patients who are CMV-positive are enrolled in the CMV prophylaxis substudy
All patients will be enrolled within the first 18 months of the study They will be randomized to 1 of 2 groups Group 1 will be comprised of 1080 patients and will receive adefovir dipivoxil plus L-carnitine and group 2 will be comprised of 1080 patients and will receive a placebo plus L-carnitine At least the first 400 patients enrolled 200 in each group will comprise the safety-HIV virology cohort These patients will have more frequent follow up visits additional laboratory evaluations and more intensive safety data information during the first 6 months NOTE At least 850 patients who are infected with CMV are followed for the development of CMV end-organ disease in a CMV prophylaxis substudy
AS PER AMENDMENT 8797 All patients are enrolled in the primary study and randomized to the treatment or placebo regimen Within the primary study patients meeting specified criteria may be enrolled in one or more of the following cohorts
1 Safety-HIV virology cohort at least the first 400 patients enrolled in the study regardless of CMV status
2 CMV bDNA cohort those patients in the safety-HIV virology cohort who are CMV-positive
3 CMV-virology cohort the first 400 patients in the CMV bDNA cohort enrolled at sites able to obtain CMV urine cultures
All patients who are CMV-positive are enrolled in the CMV prophylaxis substudy
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 11589 | REGISTRY | DAIDS ES | None |