Ignite Creation Date:
2024-05-05 @ 11:22 AM
Last Modification Date:
2024-10-26 @ 9:02 AM
Study NCT ID:
NCT00000887
Status:
COMPLETED
Last Update Posted:
2021-10-29
First Post:
1999-11-02
Brief Title:
A Study to Evaluate the Safety and Tolerance of Nelfinavir NFV Given With Zidovudine ZDV and Lamivudine 3TC in HIV-Positive Pregnant Women and Their Infants
Sponsor:
National Institute of Allergy and Infectious Diseases NIAID
Organization:
National Institute of Allergy and Infectious Diseases NIAID
Study Overview
Official Title:
A Phase I Trial of the Safety Tolerance and Pharmacokinetics of Oral Nelfinavir Viracept Co-Administered With Zidovudine ZDV and Lamivudine 3TC in HIV Infected Pregnant Women and Their Infants
Status:
COMPLETED
Status Verified Date:
2021-10
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 see if giving nelfinavir NFV plus zidovudine ZDV plus lamivudine 3TC to HIV-positive pregnant women and their babies is safe This study will also look at how long these drugs stay in the blood
ZDV has been given to mothers in the past to reduce the chances of passing HIV on to their babies However better treatments are needed to further reduce these chances and to better suit the treatment needs of mothers and their children Taking a combination of anti-HIV drugs during pregnancy may be an answer
ZDV has been given to mothers in the past to reduce the chances of passing HIV on to their babies However better treatments are needed to further reduce these chances and to better suit the treatment needs of mothers and their children Taking a combination of anti-HIV drugs during pregnancy may be an answer
Detailed Description:
Despite the dramatic reduction of perinatal HIV transmission by the administration of ZDV to mother and infant new and more potent strategies are needed to further reduce perinatal transmission and better suit the diverse treatment needs of these patients Initiation of triple antiretroviral combinations during gestation particularly combinations that include drugs that cross the placenta such as 3TC may be the most effective in reducing maternal virus load to its lowest levels prior to delivery
Women receive nelfinavir plus 3TC plus ZDV antepartum Study Day 0 until onset of active labor through postpartum after cord clamped to 12 weeks AS PER AMENDMENT 102897 If patient presents in active labor with less than 1 hour to delivery time the institutional protocol for ZDV infusion during labor should be followed AS PER AMENDMENT 12699 For maternal dosing one Combivir tablet bid can be substituted for the individual formulation of 3TC and ZDV For mothers who receive Combivir during the antepartum period Combivir is held during labor and delivery and the separate formulations of ZDV and 3TC are used Patients who prematurely discontinue study treatment should continue to be followed on study for the duration of the study Full pharmacokinetic sampling is performed 10 to 15 days after start of therapy AS PER AMENDMENT 2700 10 to 15 days after study entry for women currently taking nelfinavir and again 5 to 6 weeks after delivery A maternal blood sample and cord blood sample is collected at birth for analysis of nelfinavir concentrations Maternal HIV RNA in plasma is monitored throughout the study Cervicovaginal secretions are collected at entry late gestation and postpartum to assess the presence of HIV A single pharmacokinetics sample is collected with each cervicovaginal secretion Serial CD4CD8 activation markers are measured in women during gestation and postpartum Infants receive nelfinavir plus 3TC plus ZDV beginning approximately 12 hours following birth and continuing for 6 weeks After birth several blood samples are collected from the infant for determination of washout kinetics of nelfinavir Full pharmacokinetics sampling is performed 5 to 8 days post birth and 5 to 6 weeks following multiple doses Pharmacokinetic samples are analyzed on the first six mother-infant pairs and dosing may be adjusted accordingly for the next cohort Agouron has agreed to make nelfinavir available to all interested study participants for a period of 6 months after the study via the patient assistance program
Women receive nelfinavir plus 3TC plus ZDV antepartum Study Day 0 until onset of active labor through postpartum after cord clamped to 12 weeks AS PER AMENDMENT 102897 If patient presents in active labor with less than 1 hour to delivery time the institutional protocol for ZDV infusion during labor should be followed AS PER AMENDMENT 12699 For maternal dosing one Combivir tablet bid can be substituted for the individual formulation of 3TC and ZDV For mothers who receive Combivir during the antepartum period Combivir is held during labor and delivery and the separate formulations of ZDV and 3TC are used Patients who prematurely discontinue study treatment should continue to be followed on study for the duration of the study Full pharmacokinetic sampling is performed 10 to 15 days after start of therapy AS PER AMENDMENT 2700 10 to 15 days after study entry for women currently taking nelfinavir and again 5 to 6 weeks after delivery A maternal blood sample and cord blood sample is collected at birth for analysis of nelfinavir concentrations Maternal HIV RNA in plasma is monitored throughout the study Cervicovaginal secretions are collected at entry late gestation and postpartum to assess the presence of HIV A single pharmacokinetics sample is collected with each cervicovaginal secretion Serial CD4CD8 activation markers are measured in women during gestation and postpartum Infants receive nelfinavir plus 3TC plus ZDV beginning approximately 12 hours following birth and continuing for 6 weeks After birth several blood samples are collected from the infant for determination of washout kinetics of nelfinavir Full pharmacokinetics sampling is performed 5 to 8 days post birth and 5 to 6 weeks following multiple doses Pharmacokinetic samples are analyzed on the first six mother-infant pairs and dosing may be adjusted accordingly for the next cohort Agouron has agreed to make nelfinavir available to all interested study participants for a period of 6 months after the study via the patient assistance program
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 353 | Registry Identifier | DAIDS ES | None |
| 10603 | REGISTRY | None | None |