Ignite Creation Date:
2024-05-05 @ 11:28 AM
Last Modification Date:
2024-10-26 @ 9:08 AM
Study NCT ID:
NCT00059384
Status:
COMPLETED
Last Update Posted:
2008-09-17
First Post:
2003-04-23
Brief Title:
Alternative Dosing Strategy for Anti-HIV Drugs
Sponsor:
National Institute of Allergy and Infectious Diseases NIAID
Organization:
National Institute of Allergy and Infectious Diseases NIAID
Study Overview
Official Title:
Concentration-Controlled Antiretroviral Therapy in Persons Experiencing Persistent Viremia
Status:
COMPLETED
Status Verified Date:
2007-07
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:
Anti-HIV drugs are usually given to patients at fixed standardized doses This study will investigate alternative ways of dosing anti-HIV drugs to improve viral control
Study hypothesis The optimal dosage regimen required to obtain the maximum benefit from antiretroviral therapy is achieved with strategies that control for pharmacokinetic and pharmacodynamic variability among patients
Study hypothesis The optimal dosage regimen required to obtain the maximum benefit from antiretroviral therapy is achieved with strategies that control for pharmacokinetic and pharmacodynamic variability among patients
Detailed Description:
While optimism for the benefits of antiretroviral therapy remain justified the response to therapy varies widely This variability arises because of differences among patients in virologic immunologic behavioral and pharmacologic factors all of which impact therapeutic success
Antiretroviral agents are presently administered to adults in standard fixed doses However the same dose does not produce the same systemic and intracellular concentrations in all patients Recent research has shown that adjusting the doses of antiretroviral agents to achieve target concentrations in plasma is associated with an improved anti-HIV response compared with standard dose therapy This study will extend the paradigm of concentration-controlled therapy to develop intensified pharmacologic regimens for patients experiencing persistent viremia while receiving antiretroviral therapy
Two approaches will be investigated 1 a regimen that targets concentrations of each antiretroviral drug between the 50th and 75th percentile of expected concentrations in adults and 2 a novel regimen in which the target concentrations are based upon a desired ratio between phenotypic drug susceptibility IC90 and the concentrations of pharmacologically active moieties specifically intracellular nucleoside triphosphates and unbound protease and nonnucleoside inhibitors
Participants will be randomized to either one of the investigational approaches Cohort II or to a control group receiving standard dose therapy Cohort I There are two study visits in the first month after the first month study visits are scheduled monthly for five additional months Study visits include laboratory tests of virologic and immunologic parameters pharmacokinetic sampling and adherence counseling and monitoring
Antiretroviral agents are presently administered to adults in standard fixed doses However the same dose does not produce the same systemic and intracellular concentrations in all patients Recent research has shown that adjusting the doses of antiretroviral agents to achieve target concentrations in plasma is associated with an improved anti-HIV response compared with standard dose therapy This study will extend the paradigm of concentration-controlled therapy to develop intensified pharmacologic regimens for patients experiencing persistent viremia while receiving antiretroviral therapy
Two approaches will be investigated 1 a regimen that targets concentrations of each antiretroviral drug between the 50th and 75th percentile of expected concentrations in adults and 2 a novel regimen in which the target concentrations are based upon a desired ratio between phenotypic drug susceptibility IC90 and the concentrations of pharmacologically active moieties specifically intracellular nucleoside triphosphates and unbound protease and nonnucleoside inhibitors
Participants will be randomized to either one of the investigational approaches Cohort II or to a control group receiving standard dose therapy Cohort I There are two study visits in the first month after the first month study visits are scheduled monthly for five additional months Study visits include laboratory tests of virologic and immunologic parameters pharmacokinetic sampling and adherence counseling and monitoring
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 |
|---|---|---|---|
| 5M01RR000400-340420 | None | None | None |
| 3M01RR000400-34S1A20420รบ | None | None | None |