Ignite Creation Date:
2024-05-05 @ 11:37 AM
Last Modification Date:
2024-10-26 @ 9:11 AM
Study NCT ID:
NCT00099632
Status:
COMPLETED
Last Update Posted:
2021-11-04
First Post:
2004-12-17
Brief Title:
Comparison of Three Anti-HIV Regimens to Prevent Nevirapine Resistance in Women Who Take Nevirapine During Pregnancy
Sponsor:
National Institute of Allergy and Infectious Diseases NIAID
Organization:
National Institute of Allergy and Infectious Diseases NIAID
Study Overview
Official Title:
Maintaining Options for Mothers Study MOMS A Phase II Randomized Comparison of Three Antiretroviral Strategies Administered for 7 or 21 Days to Reduce the Emergence of Nevirapine Resistant HIV-1 Following a Single Intrapartum Dose of Nevirapine
Status:
COMPLETED
Status Verified Date:
2019-01
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:
HIV infected pregnant women may take single-dose nevirapine SD NVP prior to giving birth to prevent mother-to-child transmission MTCT of HIV However SD NVP may cause NVP resistance in the mother potentially ruling out some treatment options in the future The purpose of this study is to determine which of three anti-HIV drug regimens most effectively reduces the development of maternal NVP resistance in HIV infected pregnant women The effectiveness of short-term 7 day therapy versus long-term 21-day therapy regimens will also be compared
The study hypotheses are 1 intrapartum SD NVP with a 21-day course of antiretroviral therapy ART results in less frequent selection of NVP-resistant HIV-1 variants than intrapartum SD NVP with a 7-day course of ART and 2 a 7- or 21-day course of lamivudinezidovudine 3TCZDV emtricitabinetenofovir disoproxil fumarate FTCTDF or lopinavirritonavir LPVr following SD NVP will not select nucleoside reverse transcriptase inhibitor NRTI- or protease inhibitor PI- resistant HIV-1 variants
The study hypotheses are 1 intrapartum SD NVP with a 21-day course of antiretroviral therapy ART results in less frequent selection of NVP-resistant HIV-1 variants than intrapartum SD NVP with a 7-day course of ART and 2 a 7- or 21-day course of lamivudinezidovudine 3TCZDV emtricitabinetenofovir disoproxil fumarate FTCTDF or lopinavirritonavir LPVr following SD NVP will not select nucleoside reverse transcriptase inhibitor NRTI- or protease inhibitor PI- resistant HIV-1 variants
Detailed Description:
A major disadvantage of giving SD NVP is the potential for maternal development of NVP resistance and additional resistance to other nonnucleoside reverse transcriptase inhibitors NNRTI in the mother as a result future treatment options may be limited for these HIV infected women The purpose of the study is to determine which of three ART regimens most effectively deters the development of maternal NVP resistance in HIV infected pregnant women postpartum This study also compared the effectiveness of short-term versus long-term ART in discouraging the development of maternal NVP resistance
Some mothers in this study received ZDV monotherapy prior to SD NVP administration initiation of ZDV monotherapy was at the discretion of the site investigator and was be provided by this study Randomization was stratified by receipt of ZDV monotherapy during the pregnancy
Prior to labor mothers were randomly assigned to receive SD NVP at the onset of labor and one of three postpartum ART regimens 3TCZDV FTCTDF and LPVr In addition participants were randomly assigned to receive 7 or 21 days of their assigned postpartum treatment
Mothers were followed for 96 weeks following delivery there were 11 study visits for mothers during the study At the onset of labor medical and medication history a targeted physical exam and an obstetrical exam occurred Additional physical exams occurred on Day 1 and Weeks 1 and 3 Blood collection occurred at 8 study visits between Weeks 3 and 96 Infants were followed for up to 96 weeks after birth there were 8 study visits for infants during the study Infants who had ever been breastfed had study visits at Weeks 16 24 48 and 96 and at about 1 and 2 years of age A physical exam medication history and blood collection occurred at each infant visit Mothers and infants could be prescribed continuing ART but such ART was be provided by this study
Some mothers in this study received ZDV monotherapy prior to SD NVP administration initiation of ZDV monotherapy was at the discretion of the site investigator and was be provided by this study Randomization was stratified by receipt of ZDV monotherapy during the pregnancy
Prior to labor mothers were randomly assigned to receive SD NVP at the onset of labor and one of three postpartum ART regimens 3TCZDV FTCTDF and LPVr In addition participants were randomly assigned to receive 7 or 21 days of their assigned postpartum treatment
Mothers were followed for 96 weeks following delivery there were 11 study visits for mothers during the study At the onset of labor medical and medication history a targeted physical exam and an obstetrical exam occurred Additional physical exams occurred on Day 1 and Weeks 1 and 3 Blood collection occurred at 8 study visits between Weeks 3 and 96 Infants were followed for up to 96 weeks after birth there were 8 study visits for infants during the study Infants who had ever been breastfed had study visits at Weeks 16 24 48 and 96 and at about 1 and 2 years of age A physical exam medication history and blood collection occurred at each infant visit Mothers and infants could be prescribed continuing ART but such ART was be provided by this 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 |
|---|---|---|---|
| 10127 | REGISTRY | None | None |
| ACTG A5207 | None | None | None |
| MOMS | Registry Identifier | DAIDS ES | None |