Ignite Creation Date:
2024-05-05 @ 11:31 AM
Last Modification Date:
2024-10-26 @ 9:09 AM
Study NCT ID:
NCT00076804
Status:
TERMINATED
Last Update Posted:
2015-03-27
First Post:
2004-02-03
Brief Title:
Helping HIV Infected Patients in South Africa Adhere to Drug Regimens
Sponsor:
Johns Hopkins University
Organization:
Johns Hopkins University
Study Overview
Official Title:
DOT-HAART for HIV-Infected South African Adults
Status:
TERMINATED
Status Verified Date:
2015-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
DSMB stopped trial for futility
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Three or more anti-HIV drugs are taken in combination as part of a treatment regimen These drug regimens must be closely followed in order to be successful Having a support person watch a patient take his or her anti-HIV drugs each day may help a patient follow his or her regimen This study will see if patient-chosen treatment supporters help patients take HIV medicines correctly and improve their health
Study hypothesis The mean change in CD4 count at 12 and 24 months will be significantly higher in the directly observed therapy-highly active antiretroviral therapy DOT-HAART arm as compared to the self-administered arm
Study hypothesis The mean change in CD4 count at 12 and 24 months will be significantly higher in the directly observed therapy-highly active antiretroviral therapy DOT-HAART arm as compared to the self-administered arm
Detailed Description:
South Africa has one of the worst and fastest growing HIV epidemics in the world Highly active antiretroviral therapy HAART has been shown both at the individual and public health levels to reduce morbidity mortality and vertical and possibly horizontal HIV transmission However expenses feasibility long-term adherence and effective delivery of HAART remain formidable barriers particularly in developing nations Recently international initiatives have provided hope for widespread use of HAART at affordable cost in sub-Saharan Africa Simplified once-daily HAART regimens with directly observed therapy DOT may help to achieve high levels of treatment adherence a key component for long-term viral suppression and treatment success Peer advocates have been used to improve adherence with medical therapies in a variety of settings This study will evaluate the effectiveness and feasibility of DOT using patient-nominated peer supervisors to improve adherence to HAART in HIV infected adults in South Africa
Participants will be randomly assigned to either Peer-DOT-HAART or self-administration of a once-daily combination of the Western Cape Province ART program medications for 24 months Study measures will include CD4 cell count and HIV viral load adherence questionnaires genotypic HAART resistance testing and incidence of new or recurrent opportunistic infections
Participants will be randomly assigned to either Peer-DOT-HAART or self-administration of a once-daily combination of the Western Cape Province ART program medications for 24 months Study measures will include CD4 cell count and HIV viral load adherence questionnaires genotypic HAART resistance testing and incidence of new or recurrent opportunistic infections
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 |
|---|---|---|---|
| 1R01AI055359-01A1 | NIH | None | httpsreporternihgovquickSearch1R01AI055359-01A1 |