Ignite Creation Date:
2024-05-05 @ 5:22 PM
Last Modification Date:
2024-10-26 @ 9:31 AM
Study NCT ID:
NCT00442962
Status:
COMPLETED
Last Update Posted:
2018-10-12
First Post:
2007-03-02
Brief Title:
HIV Treatment Reinitiation in Women Who Received Anti-HIV Drugs to Prevent Mother-to-Child Transmission of HIV
Sponsor:
Advancing Clinical Therapeutics Globally for HIVAIDS and Other Infections
Organization:
Advancing Clinical Therapeutics Globally for HIVAIDS and Other Infections
Study Overview
Official Title:
The Effect of Prior Short Course Combination Antiretroviral Therapy Administered for the Prevention of Mother-to-Child Transmission pMTCT of HIV-1 on Subsequent Treatment Efficacy in Treatment-Nearly Naive Participants
Status:
COMPLETED
Status Verified Date:
2018-09
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:
Nearly Naive
Brief Summary:
The purpose of this study is to determine if pregnancy-limited short-term combination HIV treatment regimens -- which were used solely for the prevention of mother to child transmission of HIV and discontinued postpartum -- decreases the effectiveness of a standard initial regimen of anti-HIV drugs when subsequent treatment is needed
Detailed Description:
Stopping and restarting highly active antiretroviral therapy HAART is not generally recommended because it has the potential to allow drug-resistant HIV to emerge However to prevent mother-to-child transmission MTCT HIV infected women who are pregnant are temporarily put on HAART even if HIV treatment is not indicated at the time It is unknown if such short-term therapy affects the viral response to HAART later when permanent therapy is clinically indicated The purpose of this study is to determine if HAART taken to prevent MTCT during pregnancy has an effect on the ability of a standard initial regimen of HAART to suppress HIV viral load
Study follow-up will last for 48 weeks per participant Participants will take a daily regimen of efavirenz and emtricitabinetenofovir disoproxil fumarate There will be 8 clinical visits in this study visits will occur at baseline and at Weeks 2 4 8 16 24 36 and 48 At each visit a physical exam blood and urine collection and pregnancy tests will occur At some visits adherence quality-of-life and birth control interviews will be completed
Enrollment in this study will last until 47 participants have joined or until December 31 2009 whichever comes later
Study follow-up will last for 48 weeks per participant Participants will take a daily regimen of efavirenz and emtricitabinetenofovir disoproxil fumarate There will be 8 clinical visits in this study visits will occur at baseline and at Weeks 2 4 8 16 24 36 and 48 At each visit a physical exam blood and urine collection and pregnancy tests will occur At some visits adherence quality-of-life and birth control interviews will be completed
Enrollment in this study will last until 47 participants have joined or until December 31 2009 whichever comes later
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 |
|---|---|---|---|
| 1U01AI068636 | NIH | None | httpsreporternihgovquickSearch1U01AI068636 |