Ignite Creation Date:
2024-05-05 @ 11:40 AM
Last Modification Date:
2024-10-26 @ 9:11 AM
Study NCT ID:
NCT00100594
Status:
COMPLETED
Last Update Posted:
2011-02-23
First Post:
2005-01-03
Brief Title:
Efavirenz and LamivudineZidovudine for Treatment-Naive HIV Infected People in Wenxi County Shanxi Province China
Sponsor:
National Institute of Allergy and Infectious Diseases NIAID
Organization:
National Institute of Allergy and Infectious Diseases NIAID
Study Overview
Official Title:
A Feasibility Study of LamivudineZidovudine 3TCZDV Plus Efavirenz EFV as Initial Therapy of HIV-1 Infected Patients in a Rural Area of China
Status:
COMPLETED
Status Verified Date:
2011-02
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:
The purpose of this study is to determine the safety effectiveness and tolerability of the anti-HIV drugs efavirenz and lamivudinezidovudine given to treatment-naive HIV infected people in Wenxi County Shanxi Province China
Detailed Description:
HIV infection in China has reached epidemic proportions especially in poor rural communities Among the infected are former commercial plasma donors who became infected through contaminated blood collection equipment This study will evaluate the safety efficacy and tolerability of an antiretroviral ARV regimen given to treatment-naive HIV infected adults Participants will be recruited in Wenxi County Shanxi Province
This study will last 1 year At study entry all study participants will be given an ARV regimen consisting of lamivudinezidovudine twice daily and efavirenz once daily There will be 11 study visits a physical exam blood collection and vital signs measurement will occur at all study visits Participants will also receive safe sex and adherence counseling at all visits Participants will be asked to complete an adherence questionnaire and will have their pills counted at most visits
This study will last 1 year At study entry all study participants will be given an ARV regimen consisting of lamivudinezidovudine twice daily and efavirenz once daily There will be 11 study visits a physical exam blood collection and vital signs measurement will occur at all study visits Participants will also receive safe sex and adherence counseling at all visits Participants will be asked to complete an adherence questionnaire and will have their pills counted at most visits
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