Ignite Creation Date:
2024-05-05 @ 11:35 AM
Last Modification Date:
2024-10-26 @ 9:10 AM
Study NCT ID:
NCT00080522
Status:
COMPLETED
Last Update Posted:
2007-09-18
First Post:
2004-04-06
Brief Title:
Strategies for Delivering Anti-HIV Therapy in South Africa
Sponsor:
National Institute of Allergy and Infectious Diseases NIAID
Organization:
National Institute of Allergy and Infectious Diseases NIAID
Study Overview
Official Title:
Safeguard the Household A Study of HIV Antiretroviral Therapy Treatment Strategies Appropriate for a Resource Poor Country
Status:
COMPLETED
Status Verified Date:
2007-08
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:
Providing effective anti-HIV therapy in developing countries is challenging This study will evaluate new strategies for delivering anti-HIV medications to people in South Africa These strategies include using specially trained nurses to administer therapy rather than doctors treating all HIV infected members of a household at the same time and having community members observe patients taking their medications
Detailed Description:
The benefit of antiretroviral therapy is well established but limited to wealthy nations A predefined simple sequence of treatment regimens focused on extending the durability of limited treatment options has the best potential to be implemented in resource poor countries South Africa has 15 of the worlds HIVAIDS patients and a limited number of physicians to treat them l per 1600 and less than 5 infectious diseases specialists HIV patient care in the primary care setting must therefore be delivered by personnel other than doctors Further treatment strategies should include entire households to ensure maximum adherence and minimize sharing of drugs
This study will have two parts The first part will compare a first-line antiretroviral therapy regimen administered and monitored by primary health care sisters nurses with the same regimen administered by doctors The second part of the study will determine if community-based directly observed therapy DOT is significantly superior to continued clinic-based treatment support for patients who have failed first-line therapy as measured by cumulative virology failure rate The project will also evaluate the cost and economic impact of a predetermined schedule of antiretroviral therapy treatment outcomes in terms of morbidity opportunistic and endemic infections and mortality and factors contributing to treatment failure including toxicity resistance compliance and treatment interruption
In Part 1 households will be randomly assigned to receive first-line antiretroviral therapy under the monitoring and care of either an HIV-trained medical doctor supported by adherence counselors or an HIV-trained primary health care sister nurse with training in diagnosis and treatment prescription Members of the household who are HIV infected will receive stavudine lamivudine and efavirenz nevirapine or nelfinavir may be used for special populations
Participants who fail first-line antiretroviral therapy in Part 1 of the study will be entered into Part 2 of the study Participants in Part 2 will receive zidovudine didanosine and lopinavirritonavir Participants will be randomly assigned to have their treatment monitored through either a clinic-based treatment support group or through community-based directly observed treatment DOT For the DOT arm a community member will observe therapy for at least one dose a day five days a week at the home or work of the participant
HIV infected children age 3 months to 16 years who live in a participating household will also be included in the study These children will receive first-line treatment with clinic visits monitored by either the assigned sister nurse or doctor along with their households In Part 2 children will be provided with a second-line treatment regimen with continued daily monitoring of doses in the household
The study will last 5 years
This study will have two parts The first part will compare a first-line antiretroviral therapy regimen administered and monitored by primary health care sisters nurses with the same regimen administered by doctors The second part of the study will determine if community-based directly observed therapy DOT is significantly superior to continued clinic-based treatment support for patients who have failed first-line therapy as measured by cumulative virology failure rate The project will also evaluate the cost and economic impact of a predetermined schedule of antiretroviral therapy treatment outcomes in terms of morbidity opportunistic and endemic infections and mortality and factors contributing to treatment failure including toxicity resistance compliance and treatment interruption
In Part 1 households will be randomly assigned to receive first-line antiretroviral therapy under the monitoring and care of either an HIV-trained medical doctor supported by adherence counselors or an HIV-trained primary health care sister nurse with training in diagnosis and treatment prescription Members of the household who are HIV infected will receive stavudine lamivudine and efavirenz nevirapine or nelfinavir may be used for special populations
Participants who fail first-line antiretroviral therapy in Part 1 of the study will be entered into Part 2 of the study Participants in Part 2 will receive zidovudine didanosine and lopinavirritonavir Participants will be randomly assigned to have their treatment monitored through either a clinic-based treatment support group or through community-based directly observed treatment DOT For the DOT arm a community member will observe therapy for at least one dose a day five days a week at the home or work of the participant
HIV infected children age 3 months to 16 years who live in a participating household will also be included in the study These children will receive first-line treatment with clinic visits monitored by either the assigned sister nurse or doctor along with their households In Part 2 children will be provided with a second-line treatment regimen with continued daily monitoring of doses in the household
The study will last 5 years
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 |
|---|---|---|---|
| 5U19AI053217-02 | NIH | None | httpsreporternihgovquickSearch5U19AI053217-02 |
| CIPRA-SA Project 1 | None | None | None |