Ignite Creation Date:
2024-05-05 @ 4:56 PM
Last Modification Date:
2024-10-26 @ 9:25 AM
Study NCT ID:
NCT00341393
Status:
COMPLETED
Last Update Posted:
2017-07-02
First Post:
2006-06-19
Brief Title:
Validation of System for Monitoring the Effectiveness of Antiretroviral Therapy in HIV-Infected Patients in Africa
Sponsor:
National Institute of Allergy and Infectious Diseases NIAID
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
Validation of Algorithm for Monitoring the Virological Efficacy of Antiretroviral Therapy in Africa
Status:
COMPLETED
Status Verified Date:
2007-11-15
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:
This study will evaluate a system for predicting the effectiveness of antiretroviral treatment in African HIV clinics where standard testing methods for measuring viral load such as RNA polymerase chain reaction are not available or affordable Without accurate tests to monitor viral load treatment decisions often are based on insufficient clinical and immunologic information This study will see if combined analysis of patients antiretroviral treatment history adherence to treatment clinical findings and simple laboratory tests can predict whether their treatment is effectively lowering their viral load An effective monitoring system such as this could reduce the number of patients kept on ineffective treatments for prolonged periods of time as well as reduce the development of drug resistance
HIV-infected patients 18 years of age and older who are being followed in the Adult Infectious Disease Clinic at Makerere University Kampala Uganda and who have been taking antiretroviral treatment for more than 6 months may be eligible for this study
Participants medical charts are reviewed and their medical history is taken including questions about their treatment history adherence to treatment and changes in symptoms A blood sample is drawn to determine viral load CD4 and CBC counts and if necessary anti-viral resistance
HIV-infected patients 18 years of age and older who are being followed in the Adult Infectious Disease Clinic at Makerere University Kampala Uganda and who have been taking antiretroviral treatment for more than 6 months may be eligible for this study
Participants medical charts are reviewed and their medical history is taken including questions about their treatment history adherence to treatment and changes in symptoms A blood sample is drawn to determine viral load CD4 and CBC counts and if necessary anti-viral resistance
Detailed Description:
Routine virological monitoring of HIV-infected patients on antiretroviral therapy ART is not currently affordable or available in most African HIV clinics using standard methods such as RNA polymerase chain reaction PCR Alternative cheaper technologies to quantify the viral load are still awaited Therefore the majority of patients are monitored just clinically and sometimes immunologically Decisions about switching to second-line ART for treatment failure are based upon insensitive for virological failure clinical and immunological criteria such as those suggested by the World Health Organization WHO
We hypothesize that using a combination of detailed treatment and adherence history and changes in clinical and laboratory parameters virological failure or success may be predicted in the majority of patients taking ART in a typical African HIV clinic Using a monitoring algorithm in which patients are classified according to their likelihood of failure it would be possible to reduce the number of viral loads required by an ART clinic while at the same time increasing the detection of those failing virologically enabling a switch to a new effective regimen earlier than would be possible using the WHO criteria
Therefore the protocol team proposes a cross-sectional study of patients being treated in a busy African HIV clinic We will include protease-inhibitor PI-naive patients who are on first-line non-nucleoside reverse transcriptase inhibitors NNRTI based ART and have been on treatment for more than 6 months Each patient will undergo a structured interview have their notes reviewed and have blood taken for complete blood count CD4 viral load and genotypic and phenotypic anti-viral resistance testing if necessary
Treatment adherence clinical and laboratory parameters would then be individually and collectively assessed for their ability to predict virological failure using various statistical procedures including a classification and regression tree CART analysis From this the monitoring algorithm would be refined Its performance would then be compared against the current WHO recommendations for switching therapy to see what proportion of patients failing virologically could be switched earlier using this system and at what extra cost
Such a monitoring system could reduce the number of patients being allowed to fail their first-line regimens for prolonged periods of time for an affordable increase in cost This could therefore reduce the evolution and transmission of drug resistance and significantly prolong the effectiveness of the roll out of ART in Africa
We hypothesize that using a combination of detailed treatment and adherence history and changes in clinical and laboratory parameters virological failure or success may be predicted in the majority of patients taking ART in a typical African HIV clinic Using a monitoring algorithm in which patients are classified according to their likelihood of failure it would be possible to reduce the number of viral loads required by an ART clinic while at the same time increasing the detection of those failing virologically enabling a switch to a new effective regimen earlier than would be possible using the WHO criteria
Therefore the protocol team proposes a cross-sectional study of patients being treated in a busy African HIV clinic We will include protease-inhibitor PI-naive patients who are on first-line non-nucleoside reverse transcriptase inhibitors NNRTI based ART and have been on treatment for more than 6 months Each patient will undergo a structured interview have their notes reviewed and have blood taken for complete blood count CD4 viral load and genotypic and phenotypic anti-viral resistance testing if necessary
Treatment adherence clinical and laboratory parameters would then be individually and collectively assessed for their ability to predict virological failure using various statistical procedures including a classification and regression tree CART analysis From this the monitoring algorithm would be refined Its performance would then be compared against the current WHO recommendations for switching therapy to see what proportion of patients failing virologically could be switched earlier using this system and at what extra cost
Such a monitoring system could reduce the number of patients being allowed to fail their first-line regimens for prolonged periods of time for an affordable increase in cost This could therefore reduce the evolution and transmission of drug resistance and significantly prolong the effectiveness of the roll out of ART in Africa
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 |
|---|---|---|---|
| 06-I-N101 | None | None | None |