Ignite Creation Date:
2024-05-05 @ 11:45 AM
Last Modification Date:
2024-10-26 @ 9:12 AM
Study NCT ID:
NCT00120510
Status:
COMPLETED
Last Update Posted:
2014-10-15
First Post:
2005-07-14
Brief Title:
Early Versus Standard Start of Anti-HIV Therapy for Treatment-Naive Adults in Haiti
Sponsor:
National Institute of Allergy and Infectious Diseases NIAID
Organization:
National Institute of Allergy and Infectious Diseases NIAID
Study Overview
Official Title:
A Randomized Clinical Trial to Determine the Efficacy of Early Versus Standard Antiretroviral Therapy in HIV Infected Adults With CD4 T Cell Counts Between 200 and 350 Cellsmm3
Status:
COMPLETED
Status Verified Date:
2014-10
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 treatment consisting of lamivudinezidovudine 3TCZDV and efavirenz EFV is the current standard of care for initial treatment of HIV in most areas of the world The purpose of this study is to determine the best time to start this anti-HIV treatment in treatment-naive adults in Haiti
Detailed Description:
In many parts of the world initial standard of care for HIV includes 3TCZDV and the non-nucleoside reverse transcriptase inhibitor EFV However it is unclear if early CD4 count less than 350 cellsmm3 or delayed CD4 count less than 200 cellsmm3 therapy initiation leads to improved survival This study will determine the most appropriate time to initiate ART in HIV infected individuals in Haiti The study will enroll patients from the Haitian Study Group on Kaposis Sarcoma and Opportunistic Infections GHESKIO Centers Some participants in this study will have active pulmonary tuberculosis TB
This study will last at least 3 years Participants will be randomly assigned to one of two groups at study entry Group A participants will receive 3TCZDV twice daily and EFV once daily at study enrollment Participants receiving TB therapy at the time of enrollment may be observed for 2 weeks prior to beginning early therapy Dosage adjustment of EFV may be necessary for participants receiving rifampin as part of their TB therapy Group B participants will receive 3TCZDV twice daily and EFV once daily when they develop clinical AIDS or their CD4 count drops below 200 cellsmm3 WHO Stage IV Directly observed therapy will be used for the first two months of treatment for every participant
Group A participants will have 14 study visits after beginning treatment the visits will occur at Months 1 2 3 and every 3 months thereafter Medical and medication history physical exams and contraceptive counseling for women will occur at all visits HIV counseling blood collection and HIV staging will occur at most visits At some study visits Group A participants will be asked to complete quality of life and adherence questionnaires Group B participants will have 14 study visits after study entry and will begin treatment when they meet WHO criteria Assessments will be the same as for Group A Any participant who fails the first-line regimen during the study will switch to a second-line ART regimen
This study will last at least 3 years Participants will be randomly assigned to one of two groups at study entry Group A participants will receive 3TCZDV twice daily and EFV once daily at study enrollment Participants receiving TB therapy at the time of enrollment may be observed for 2 weeks prior to beginning early therapy Dosage adjustment of EFV may be necessary for participants receiving rifampin as part of their TB therapy Group B participants will receive 3TCZDV twice daily and EFV once daily when they develop clinical AIDS or their CD4 count drops below 200 cellsmm3 WHO Stage IV Directly observed therapy will be used for the first two months of treatment for every participant
Group A participants will have 14 study visits after beginning treatment the visits will occur at Months 1 2 3 and every 3 months thereafter Medical and medication history physical exams and contraceptive counseling for women will occur at all visits HIV counseling blood collection and HIV staging will occur at most visits At some study visits Group A participants will be asked to complete quality of life and adherence questionnaires Group B participants will have 14 study visits after study entry and will begin treatment when they meet WHO criteria Assessments will be the same as for Group A Any participant who fails the first-line regimen during the study will switch to a second-line ART regimen
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 |
|---|---|---|---|
| 10403 | REGISTRY | DAIDS ES number | httpsreporternihgovquickSearch5K24AI051966-03 |
| 5K24AI051966-03 | NIH | None | None |