Ignite Creation Date:
2024-05-05 @ 8:03 PM
Last Modification Date:
2024-10-26 @ 9:58 AM
Study NCT ID:
NCT00797381
Status:
UNKNOWN
Last Update Posted:
2008-11-25
First Post:
2008-11-24
Brief Title:
Efficacy and Safety of MK-0518 in Treatment-Experienced HIV-1 Infected Adult Patients With Hemophilia
Sponsor:
Shanghai Public Health Clinical Center
Organization:
Shanghai Public Health Clinical Center
Study Overview
Official Title:
A Randomized Double-Blind Placebo-Controlled Study to Evaluate the Efficacy and Safety Tolerability of MK-0518 in Treatment-Experienced HIV-1 Infected Adult Patients With Hemophilia
Status:
UNKNOWN
Status Verified Date:
2008-11
Last Known Status:
NOT_YET_RECRUITING
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:
This is an randomized double-blind placebo-controlled study to assess the safety tolerability and efficacy of MK-0518 compared to placebo when combined with other antiretroviral drugs in treatment-experienced HIV-infected patients with hemophilia
Subjects enrolled in the study sign the consent form then are randomly assigned to MK-0518 400 mg twice daily plus optimized background therapy OBT group or placebo plus OBT groupEach group concludes at least 50 subjects For each patient detection of HIV viral load and CD4 T lymphocyte count is done at screening and at weeks 4 8 12 and 24 The safety profile of MK-0518 is monitored according to patients complaints and the results of physical and laboratory examinations
The safety and efficacy of MK-0518 400 mg bid compared to placebo both in combination with OBT will be assessed by review of the accumulated study data in HIV-infected patients with hemophilia
Subjects enrolled in the study sign the consent form then are randomly assigned to MK-0518 400 mg twice daily plus optimized background therapy OBT group or placebo plus OBT groupEach group concludes at least 50 subjects For each patient detection of HIV viral load and CD4 T lymphocyte count is done at screening and at weeks 4 8 12 and 24 The safety profile of MK-0518 is monitored according to patients complaints and the results of physical and laboratory examinations
The safety and efficacy of MK-0518 400 mg bid compared to placebo both in combination with OBT will be assessed by review of the accumulated study data in HIV-infected patients with hemophilia
Detailed Description:
1 Objective
To assess the safety tolerability and efficacy of MK-0518 compared to placebo when combined with other antiretroviral drugs in treatment-experienced HIV-infected patients with hemophilia
2 Background and Significance
Current anti-HIV drugs are mainly reverse transcriptase inhibitors which include nucleoside reverse transcriptase inhibitorsNRTIs and non-nucleoside reverse transcriptase inhibitorsNNRTIs and protease inhibitorsPIs However HIV can become rapidly resistant to them due to its high rate of mutation while replicating which forces people to seek new targets for anti-HIV therapy continually Integrase is an another enzyme essential for HIV reproduction To inhibit integrase activity is an effective measure to suppress HIV replication MK-0518Raltegravirwas approved by the United States Food and Drug AdministrationFDA on October 12th 2007 due to its potent antiviral activity and became the first-to-market integrase inhibitorCompared with other antiviral drugs it has new action mechanism and target site so there is no cross resistance between it and them which makes it a good option for patients with multi-drug resistant HIV strains HIV infection is very common in hemophiliac patients who need continuous infusion of clotting productsand the chance of getting HIV infection for hemophilia patients is very high especially before 1985 when non-virus-inactivated factor concentrates were widely used Many hemophilia patients were infected with HIV and AIDS became their main cause of deathThe recommended first-line antiretroviral regimen for HIVAIDS patients with hemophilia concludes two NRTIs and one NNRTIs while protease inhibitors are not recommended to use in these patients because they are likely to worsen bleeding tendency So if HIVAIDS patients with hemophilia are resistant to NRTIs and NNRTIs there are few remaining options for them to choose as part of second-line drugs However MK-0518a drug with novel anti-HIV mechanism different with NRTIs and NNRTIs may be used in HIVAIDS patients with hemophilia as the second-line drug
3 Study design
1 Patients Enrollment
2 Patients enrolled in the study sign consent form
3 Select an optimized background therapyOBT for each subject
4 Randomization patients are randomly assigned to MK-0518 400 mg twice daily plus OBT group or placebo plus OBT group each group concludes at least 50 subjects
5 Data collection for each patient detection of HIV viral load and CD4 T lymphocyte count is done at screening and at weeks4 8 12 16 and 24 The safety profile of MK-0518 is monitored according to patients complaints and the results of physical and laboratory examinations
6 Endpoints of study The primary endpoint is the the safety and tolerability of MK-0518 400 mg bid compared to placebo both in combination with OBTThe secondary endpoint is antiretroviral activity of MK-0518 400 mg bid compared to placebo both in combination with OBT
To assess the safety tolerability and efficacy of MK-0518 compared to placebo when combined with other antiretroviral drugs in treatment-experienced HIV-infected patients with hemophilia
2 Background and Significance
Current anti-HIV drugs are mainly reverse transcriptase inhibitors which include nucleoside reverse transcriptase inhibitorsNRTIs and non-nucleoside reverse transcriptase inhibitorsNNRTIs and protease inhibitorsPIs However HIV can become rapidly resistant to them due to its high rate of mutation while replicating which forces people to seek new targets for anti-HIV therapy continually Integrase is an another enzyme essential for HIV reproduction To inhibit integrase activity is an effective measure to suppress HIV replication MK-0518Raltegravirwas approved by the United States Food and Drug AdministrationFDA on October 12th 2007 due to its potent antiviral activity and became the first-to-market integrase inhibitorCompared with other antiviral drugs it has new action mechanism and target site so there is no cross resistance between it and them which makes it a good option for patients with multi-drug resistant HIV strains HIV infection is very common in hemophiliac patients who need continuous infusion of clotting productsand the chance of getting HIV infection for hemophilia patients is very high especially before 1985 when non-virus-inactivated factor concentrates were widely used Many hemophilia patients were infected with HIV and AIDS became their main cause of deathThe recommended first-line antiretroviral regimen for HIVAIDS patients with hemophilia concludes two NRTIs and one NNRTIs while protease inhibitors are not recommended to use in these patients because they are likely to worsen bleeding tendency So if HIVAIDS patients with hemophilia are resistant to NRTIs and NNRTIs there are few remaining options for them to choose as part of second-line drugs However MK-0518a drug with novel anti-HIV mechanism different with NRTIs and NNRTIs may be used in HIVAIDS patients with hemophilia as the second-line drug
3 Study design
1 Patients Enrollment
2 Patients enrolled in the study sign consent form
3 Select an optimized background therapyOBT for each subject
4 Randomization patients are randomly assigned to MK-0518 400 mg twice daily plus OBT group or placebo plus OBT group each group concludes at least 50 subjects
5 Data collection for each patient detection of HIV viral load and CD4 T lymphocyte count is done at screening and at weeks4 8 12 16 and 24 The safety profile of MK-0518 is monitored according to patients complaints and the results of physical and laboratory examinations
6 Endpoints of study The primary endpoint is the the safety and tolerability of MK-0518 400 mg bid compared to placebo both in combination with OBTThe secondary endpoint is antiretroviral activity of MK-0518 400 mg bid compared to placebo both in combination with OBT
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