Ignite Creation Date:
2024-05-05 @ 9:57 AM
Last Modification Date:
2024-10-26 @ 9:02 AM
Study NCT ID:
NCT00000888
Status:
COMPLETED
Last Update Posted:
2021-10-29
First Post:
1999-11-02
Brief Title:
Safety and Effectiveness of Ritonavir Plus Lamivudine Plus Zidovudine in HIV-Infected Pregnant Women and Their Babies
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 Ritonavir Co-Administered With Lamivudine 3TC and Zidovudine ZDV in HIV-1-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 it is safe and effective to give ritonavir RTV plus lamivudine 3TC plus zidovudine ZDV to HIV-infected pregnant women during pregnancy and to their babies after birth
Pregnant women who are HIV-positive are at risk of giving HIV to their babies during pregnancy or delivery It is important to learn how to prevent HIV-positive pregnant women from giving HIV to their babies RTV and ZDV have been shown to be safe and effective against HIV in adults The combination of 3 anti-HIV drugs RTV 3TC and ZDV may help prevent HIV infection from mother to infant but studies are needed to determine whether they are safe and effective during pregnancy
Pregnant women who are HIV-positive are at risk of giving HIV to their babies during pregnancy or delivery It is important to learn how to prevent HIV-positive pregnant women from giving HIV to their babies RTV and ZDV have been shown to be safe and effective against HIV in adults The combination of 3 anti-HIV drugs RTV 3TC and ZDV may help prevent HIV infection from mother to infant but studies are needed to determine whether they are safe and effective during pregnancy
Detailed Description:
Controlled studies of the pharmacokinetics and safety of new drugs are critical to the development of alternative therapies for the prevention of perinatal transmission of HIV-1 The dosing regimen of RTV and ZDV used to treat pregnant women in this study has been shown to be safe and effective against HIV in adults Little is known about the metabolism and tolerance of these drugs during pregnancy and Phase I studies are needed to determine dosage safety and tolerance Protease inhibitors in combination with other antiretroviral drugs may help reduce the rate of perinatal transmission of HIV-1
Pregnant women start with RTV increasing gradually over a few days plus 3TC plus ZDV until active labor Intrapartum women receive RTV plus 3TC plus ZDV then postpartum after cord clamped until 12 weeks postpartum RTV plus 3TC plus ZDV AS PER AMENDMENT 2999 For maternal dosing one Combivir tablet containing 3TC and ZDV may be administered in place of the individual agents 3TC and ZDV During the intrapartum period Combivir is held and the patient follows intrapartum 3TCZDV dosing During the intrapartum period no RTV is given after the onset of active labor During the postpartum period RTV is begun as soon as oral intake is allowable following delivery During the postpartum period Combivir may be resumed All subjects who prematurely discontinue study treatment should continue to be followed for the duration of the study AS PER AMENDMENT 92899 During the intrapartum period RTV is given at the start of active labor Infants begin 3TC and ZDV as soon as oral intake is tolerated Infants participate in one of two cohorts The first four infants delivered Cohort 1 receive RTV as a single dose between Days 8 and 12 The next six infants delivered Cohort 2 start RTV at 2-3 days of life The dosing schedule is based on Cohort 1 drug pharmacokinetics data AS PER AMENDMENT 2999 Cohort 1 is expanded to seven motherinfant pairs AS PER AMENDMENT 92899 Cohort 1 is expanded to eight motherinfant pairs Both maternal and infant blood is drawn to assess drug pharmacokinetics Cervical secretions are collected to assess presence of virus In addition all placentas are examined by histopathology to determine the role of placenta on preterm delivery in women receiving combination antiretroviral therapy
Pregnant women start with RTV increasing gradually over a few days plus 3TC plus ZDV until active labor Intrapartum women receive RTV plus 3TC plus ZDV then postpartum after cord clamped until 12 weeks postpartum RTV plus 3TC plus ZDV AS PER AMENDMENT 2999 For maternal dosing one Combivir tablet containing 3TC and ZDV may be administered in place of the individual agents 3TC and ZDV During the intrapartum period Combivir is held and the patient follows intrapartum 3TCZDV dosing During the intrapartum period no RTV is given after the onset of active labor During the postpartum period RTV is begun as soon as oral intake is allowable following delivery During the postpartum period Combivir may be resumed All subjects who prematurely discontinue study treatment should continue to be followed for the duration of the study AS PER AMENDMENT 92899 During the intrapartum period RTV is given at the start of active labor Infants begin 3TC and ZDV as soon as oral intake is tolerated Infants participate in one of two cohorts The first four infants delivered Cohort 1 receive RTV as a single dose between Days 8 and 12 The next six infants delivered Cohort 2 start RTV at 2-3 days of life The dosing schedule is based on Cohort 1 drug pharmacokinetics data AS PER AMENDMENT 2999 Cohort 1 is expanded to seven motherinfant pairs AS PER AMENDMENT 92899 Cohort 1 is expanded to eight motherinfant pairs Both maternal and infant blood is drawn to assess drug pharmacokinetics Cervical secretions are collected to assess presence of virus In addition all placentas are examined by histopathology to determine the role of placenta on preterm delivery in women receiving combination antiretroviral therapy
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 354 | Registry Identifier | DAIDS ES | None |
| 10604 | REGISTRY | None | None |