Ignite Creation Date:
2024-05-05 @ 11:50 AM
Last Modification Date:
2024-10-26 @ 9:14 AM
Study NCT ID:
NCT00144157
Status:
COMPLETED
Last Update Posted:
2013-11-14
First Post:
2005-09-02
Brief Title:
Open Label Study of NVPCBV Treatment in Women Who Have Received sdNVP for the pMTCT of HIV
Sponsor:
Boehringer Ingelheim
Organization:
Boehringer Ingelheim
Study Overview
Official Title:
An Open-Label Study of Nevirapine Plus Combivir ZDV3TC Treatment in Women Who Have Previously Received a Nevirapine Regimen for the Prevention of Mother to Child Transmission pMTCT of HIV-1
Status:
COMPLETED
Status Verified Date:
2013-11
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:
To determine the response to treatment with NVP ZDV and 3TC in HIV positive women who previously received NVP for the prevention of mother to child transmission
Detailed Description:
An open-label single arm multicentre study to determine the virologic and immunologic responsiveness of women who previously received a regimen of nevirapine for the prevention of MTCT to a regimen of nevirapine and ZDV3TC treatment As well as to evaluate the proportion of patients who fail this treatment at 24 and 48 weeks and to evaluate the resistance profile of HIV isolates from patients who fail nevirapine and ZDV3TC treatment
Study Hypothesis
When a drug leading to selection of a resistant viral population is withdrawn the original wildtype virus over time becomes the predominant virus again However low frequency below level of detection of drug resistant viral sub-populations may be retained which could mean that the drug resistant variant might reappear rapidly should the same drug be reintroduced as part of combination therapy at a later stageTherefore this study is proposed to evaluate whether there is an impact of single dose nevirapine for the prevention of MTCT on the subsequent response to a standard HAART regimen that contains nevirapine
Comparisons
trial 11001090
Study Hypothesis
When a drug leading to selection of a resistant viral population is withdrawn the original wildtype virus over time becomes the predominant virus again However low frequency below level of detection of drug resistant viral sub-populations may be retained which could mean that the drug resistant variant might reappear rapidly should the same drug be reintroduced as part of combination therapy at a later stageTherefore this study is proposed to evaluate whether there is an impact of single dose nevirapine for the prevention of MTCT on the subsequent response to a standard HAART regimen that contains nevirapine
Comparisons
trial 11001090
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