Ignite Creation Date:
2024-05-05 @ 11:07 AM
Last Modification Date:
2024-10-26 @ 9:02 AM
Study NCT ID:
NCT00000944
Status:
COMPLETED
Last Update Posted:
2021-10-29
First Post:
1999-11-02
Brief Title:
A Study to Evaluate the Safety and Tolerance of Combination Anti-HIV Drug Therapy Indinavir Lamivudine and Zidovudine 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 Indinavir Co-Administered With Lamivudine 3TC and Zidovudine ZDV in HIV-1-Infected Pregnant Women During Gestation and Post Partum and in Their Infants Post Maternal Dosing
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 determine if a combination anti-HIV drug treatment regimen of indinavir plus lamivudine 3TC plus zidovudine ZDV is effective in treating HIV and in reducing the chances of passing HIV from mother to child This study will also examine if this combination is well tolerated by HIV-positive pregnant women and if a combination of 3TC plus ZDV is safe for newborns
Previous studies in adults and children have shown that indinavir plus 3TC plus ZDV can reduce the amount of HIV in the blood Most HIV-positive pregnant women usually take ZDV to treat HIV and to reduce the chances of giving HIV to their babies The combination of drugs in this study may be more effective than ZDV alone
Previous studies in adults and children have shown that indinavir plus 3TC plus ZDV can reduce the amount of HIV in the blood Most HIV-positive pregnant women usually take ZDV to treat HIV and to reduce the chances of giving HIV to their babies The combination of drugs in this study may be more effective than ZDV alone
Detailed Description:
Despite the dramatic reduction of perinatal HIV transmission following the administration of ZDV to mothers and infants new more effective strategies are needed An increasing number of women may require combination antiretroviral therapy for their own disease because they may be resistant to ZDV may have high viral loads or may have previously transmitted HIV to an infant while on ZDV monotherapy The initiation of triple combination therapy including a protease inhibitor indinavir during gestation may be the most effective in reducing maternal virus load prior to delivery thereby potentially benefitting both mother and child
Women
Antepartum until active labor Indinavir plus 3TC plus ZDV Intrapartum active labor until cord clamping 3TC plus ZDV Postpartum after cord clamped to 12 weeks Indinavir plus 3TC plus ZDV
Infants
3TC plus ZDV as soon as oral intake is tolerated preferably within 12 hours of birth and continuing for 6 weeks
AS PER AMENDMENT 12799 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
Women
Antepartum until active labor Indinavir plus 3TC plus ZDV Intrapartum active labor until cord clamping 3TC plus ZDV Postpartum after cord clamped to 12 weeks Indinavir plus 3TC plus ZDV
Infants
3TC plus ZDV as soon as oral intake is tolerated preferably within 12 hours of birth and continuing for 6 weeks
AS PER AMENDMENT 12799 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
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 |
|---|---|---|---|
| 10606 | REGISTRY | DAIDS ES Registry Number | None |
| PACTG 358 | None | None | None |