Ignite Creation Date:
2024-05-05 @ 11:50 AM
Last Modification Date:
2024-10-26 @ 9:14 AM
Study NCT ID:
NCT00144183
Status:
COMPLETED
Last Update Posted:
2013-11-03
First Post:
2005-09-02
Brief Title:
A Study of Single Dose Nevirapine NVP Combined With Combivir for the Prevention of Mother to Child Transmission pMTCT - Treatment Options Preservation Study TOPS
Sponsor:
Boehringer Ingelheim
Organization:
Boehringer Ingelheim
Study Overview
Official Title:
An Open-label Study Evaluating the Resistance Profile of Single Dose NevirapineNVP When Combined With a 4 or 7 Day Course of Combivir ZDV3TC Compared to Single Dose Nevirapine for the Prevention of Mother to Child Transmission pMTCT of HIV - Treatment Options Preservation Study TOPS
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 whether a regimen of single dose nevirapine combined with either 4 or 7 days of Combivir compared to a regimen of single dose nevirapine for the prevention of mother to child transmission can reduce the rate of development of drug resistant mutations of HIV-1 in HIV-1 infected pregnant women who have not received antiretroviral therapy previously
Detailed Description:
An open-label randomised multicentre study to determine whether a regimen of single dose nevirapine combined with either 4 or 7 days of Combivir compared to a regimen of single dose nevirapine for the prevention of mother to child transmission can reduce the rate of development of drug resistant mutations of HIV-1 in HIV-1 infected pregnant women who have not received antiretroviral therapy previously
An interim analysis of the first 61 patients showed that a clinical and statistical difference exists between the occurrence of HIV-1 NNRTI resistant mutations in the single dose nevirapine only arm 50 and the two other combination arms 9 These findings partially answered the objectives outlined in the initial objectives Consequently enrolment onto the single dose nevirapine arm was terminated The objective of the trial was modified to compare whether either the 4 or the 7 day combination of ZDV3TC and nevirapine would result in any significant reduction in the incidence of nevirapine resistance
Study Hypothesis
Evaluations of HIV-1 resistance patterns in trials of pMTCT have demonstrated nevirapine resistant HIV-1 isolates in approximately 15-20 of mothers 4-6 weeks after receiving either a single or two dose 200mg nevirapine regimen Although the ability to detect these genotypic mutations decreases to 0 by about 18 months it is not clear whether this resistance is clinically significantHIVNET 012
Empirically then it would seem useful to develop a strategy to diminish the emergence of this early resistance therefore this study is proposed to evaluate whether the effect of 4 or 7 days of 3TC ZDV added to a single dose nevirapine regimen for the prevention of MTCT will prevent the emergence of resistance to nevirapine
Comparisons
ACTG 076 Thai PETRA HIVNET 006012 SAINT
An interim analysis of the first 61 patients showed that a clinical and statistical difference exists between the occurrence of HIV-1 NNRTI resistant mutations in the single dose nevirapine only arm 50 and the two other combination arms 9 These findings partially answered the objectives outlined in the initial objectives Consequently enrolment onto the single dose nevirapine arm was terminated The objective of the trial was modified to compare whether either the 4 or the 7 day combination of ZDV3TC and nevirapine would result in any significant reduction in the incidence of nevirapine resistance
Study Hypothesis
Evaluations of HIV-1 resistance patterns in trials of pMTCT have demonstrated nevirapine resistant HIV-1 isolates in approximately 15-20 of mothers 4-6 weeks after receiving either a single or two dose 200mg nevirapine regimen Although the ability to detect these genotypic mutations decreases to 0 by about 18 months it is not clear whether this resistance is clinically significantHIVNET 012
Empirically then it would seem useful to develop a strategy to diminish the emergence of this early resistance therefore this study is proposed to evaluate whether the effect of 4 or 7 days of 3TC ZDV added to a single dose nevirapine regimen for the prevention of MTCT will prevent the emergence of resistance to nevirapine
Comparisons
ACTG 076 Thai PETRA HIVNET 006012 SAINT
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 |
|---|---|---|---|
| MCCN219821958 | None | None | None |