Ignite Creation Date:
2024-05-05 @ 11:39 AM
Last Modification Date:
2024-10-26 @ 9:11 AM
Study NCT ID:
NCT00100568
Status:
COMPLETED
Last Update Posted:
2013-09-06
First Post:
2005-01-03
Brief Title:
Efavirenz and LamivudineZidovudine for Treatment-Naive HIV Infected Adults in Senegal
Sponsor:
National Institute of Allergy and Infectious Diseases NIAID
Organization:
National Institute of Allergy and Infectious Diseases NIAID
Study Overview
Official Title:
A Pilot Study of Safety Effectiveness and Adherence of LamivudineZidovudine and Efavirenz 3TCZDV EFV to Treat HIV-1 Infection in Senegal
Status:
COMPLETED
Status Verified Date:
2013-09
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 and effectiveness of the anti-HIV drugs efavirenz and lamivudinezidovudine given to treatment-naive HIV-infected people in Dakar Senegal
Detailed Description:
Despite a relatively low prevalence of HIV infection all HIV subtypes have been documented in Senegal Data on mutations that confer resistance to antiretroviral ARV drugs are limited to HIV subtype B adherence data are also limited The study will evaluate the safety and efficacy of an ARV regimen given to treatment-naive HIV infected adults and adolescents The study will also examine the characteristics of virologic failure and adherence in this treatment group Participants will be recruited at two sites in Dakar Senegal
This study will last 96 weeks At study entry all participants will be given an ARV regimen of lamivudinezidovudine twice daily and efavirenz once daily If toxicity or treatment failure occurs some participants may require changes in their ARV regimens There will be 14 study visits during the study a physical exam blood collection and sociodemographic and medication history assessments will occur at each visit Participants will also be asked to complete quality-of-life and adherence questionnaires An off-study visit will occur at approximately one month after Week 96 with assessments and procedures similar to visits during the study
This study will last 96 weeks At study entry all participants will be given an ARV regimen of lamivudinezidovudine twice daily and efavirenz once daily If toxicity or treatment failure occurs some participants may require changes in their ARV regimens There will be 14 study visits during the study a physical exam blood collection and sociodemographic and medication history assessments will occur at each visit Participants will also be asked to complete quality-of-life and adherence questionnaires An off-study visit will occur at approximately one month after Week 96 with assessments and procedures similar to visits during the study
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 |
|---|---|---|---|
| SN-CIPRA-001 | None | None | None |
| 10412 | REGISTRY | DAIDS-ES | None |