Ignite Creation Date:
2024-05-05 @ 11:39 AM
Last Modification Date:
2024-10-26 @ 9:11 AM
Study NCT ID:
NCT00109590
Status:
COMPLETED
Last Update Posted:
2021-11-05
First Post:
2005-04-29
Brief Title:
Reducing the Incidence of Nevirapine Resistance Mutations in Pregnant HIV Infected Women Who Receive Anti-HIV Drugs Prior to and After Giving Birth
Sponsor:
National Institute of Allergy and Infectious Diseases NIAID
Organization:
National Institute of Allergy and Infectious Diseases NIAID
Study Overview
Official Title:
Phase II Study of the Pharmacokinetics of Nevirapine and the Incidence of Nevirapine Resistance Mutations in HIV-Infected Women Receiving a Single Intrapartum Dose of Nevirapine With the Concomitant Administration of ZidovudineDidanosine or ZidovudineDidanosineLopinavirRitonavir
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:
The purpose of this study is to determine which of 3 different anti-HIV drug regimens given to HIV infected pregnant women during and after their pregnancies is most effective in reducing the incidence of nevirapine NVP resistance mutations Blood levels of NVP and lopinavirritonavir LPVr will also be studied
Study hypothesis NVP resistance following single-dose NVP can be prevented with the concomitant administration of additional antiretroviral therapy ART
Study hypothesis NVP resistance following single-dose NVP can be prevented with the concomitant administration of additional antiretroviral therapy ART
Detailed Description:
A single dose of nevirapine SD-NVP given to an HIV infected pregnant woman in labor followed by a single dose to her infant had been shown to be a simple and effective means of reducing mother-to-child transmission MTCT of HIV among women who had not received antiretroviral ART during pregnancy However development of NVP and other nonnucleoside reverse transcriptase inhibitor NNRTI-resistant virus was a concern An optimal ART regimen that can prevent selection of resistant virus while efficiently preventing MTCT was needed This study evaluated 3 different ART strategies for preventing the development of NVP resistance in HIV infected pregnant women and compared the incidence of NVP resistance mutations postpartum observed with each regimen to the incidence among historical controls NVP and LPVr pharmacokinetics PK were also evaluated in this study
Participants were randomly assigned to one of three study arms All study participants received a single dose of oral NVP at the onset of labor and oral zidovudine ZDV at the onset of labor and every three hours during labor Arm A LPVr x 7d participants received enteric-coated didanosine ddI and LPVr orally twice daily beginning at the onset of labor and continuing through 7 days postpartum oral ZDV was also taken twice daily for 7 days postpartum Arm B no LPVr participants received enteric-coated ddI beginning at the onset of labor and continued through 30 days postpartum oral ZDV was also taken twice daily for 30 days postpartum Arm C LPVr x 30d participants received enteric-coated ddI and LPVr orally twice daily beginning at the onset of labor and continued through 30 days postpartum oral ZDV was also taken twice daily for 30 days postpartum
All women were followed for at least 24 weeks postpartum Women with resistance mutations identified within 8 weeks postpartum were to be followed until 72 weeks postpartum to evaluate the persistence of the mutations All infants were followed until at least 12 weeks of age HIV-infected infants were to be followed until 24 weeks of age There were 11 study visits for women at day 10 21 and 30 and week 5 6 8 12 24 36 48 and 72 Medical history assessment a physical exam and blood collection occurred at all visits Blood collection for PK studies occurred at Days 10 21 and 30 All women were asked to complete an adherence questionnaire at Day 10 women assigned to Arms A LPVr x 7d and B no LPVr were also asked to complete an adherence questionnaire at Day 30 There were 6 study visits for infants at birth - 48 hours day 21 week 5 12 16 and 24 Medical history assessment and a physical exam occurred at most visits blood collection occurred at all visits
Data and specimens for the historical control comparison group were obtained from the PHPT-2 trial in which five of the P1032 study sites had participated between 2001 and 2003 PHPT-2 was a study of the efficacy of SD-NVP to prevent MTCT among women who received ZDV after 27 weeks gestation but no postpartum ART Criteria for inclusion in the historical comparison group included receipt of SD-NVP a CD4 count of more than 250 cells per cubic millimeter within 30 days of screening or entry and the availability of plasma samples at 10 days or 6 weeks post-partum
Lallement M Jourdain G Le Coeur S et al Single-dose perinatal nevirapine plus standard zidovudine to prevent mother-to-child transmission of HIV-1 in Thailand N Engl J Med 2004 351217-28
Participants were randomly assigned to one of three study arms All study participants received a single dose of oral NVP at the onset of labor and oral zidovudine ZDV at the onset of labor and every three hours during labor Arm A LPVr x 7d participants received enteric-coated didanosine ddI and LPVr orally twice daily beginning at the onset of labor and continuing through 7 days postpartum oral ZDV was also taken twice daily for 7 days postpartum Arm B no LPVr participants received enteric-coated ddI beginning at the onset of labor and continued through 30 days postpartum oral ZDV was also taken twice daily for 30 days postpartum Arm C LPVr x 30d participants received enteric-coated ddI and LPVr orally twice daily beginning at the onset of labor and continued through 30 days postpartum oral ZDV was also taken twice daily for 30 days postpartum
All women were followed for at least 24 weeks postpartum Women with resistance mutations identified within 8 weeks postpartum were to be followed until 72 weeks postpartum to evaluate the persistence of the mutations All infants were followed until at least 12 weeks of age HIV-infected infants were to be followed until 24 weeks of age There were 11 study visits for women at day 10 21 and 30 and week 5 6 8 12 24 36 48 and 72 Medical history assessment a physical exam and blood collection occurred at all visits Blood collection for PK studies occurred at Days 10 21 and 30 All women were asked to complete an adherence questionnaire at Day 10 women assigned to Arms A LPVr x 7d and B no LPVr were also asked to complete an adherence questionnaire at Day 30 There were 6 study visits for infants at birth - 48 hours day 21 week 5 12 16 and 24 Medical history assessment and a physical exam occurred at most visits blood collection occurred at all visits
Data and specimens for the historical control comparison group were obtained from the PHPT-2 trial in which five of the P1032 study sites had participated between 2001 and 2003 PHPT-2 was a study of the efficacy of SD-NVP to prevent MTCT among women who received ZDV after 27 weeks gestation but no postpartum ART Criteria for inclusion in the historical comparison group included receipt of SD-NVP a CD4 count of more than 250 cells per cubic millimeter within 30 days of screening or entry and the availability of plasma samples at 10 days or 6 weeks post-partum
Lallement M Jourdain G Le Coeur S et al Single-dose perinatal nevirapine plus standard zidovudine to prevent mother-to-child transmission of HIV-1 in Thailand N Engl J Med 2004 351217-28
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 |
|---|---|---|---|
| PACTG P1032 | Registry Identifier | DAIDS ES | None |
| 10137 | REGISTRY | None | None |