Ignite Creation Date:
2024-05-05 @ 11:20 AM
Last Modification Date:
2024-10-26 @ 9:02 AM
Study NCT ID:
NCT00000878
Status:
COMPLETED
Last Update Posted:
2021-10-29
First Post:
1999-11-02
Brief Title:
A Study to Evaluate the Safety and Tolerance of Stavudine d4T in Combination With 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 III Open-Label Study to Evaluate the Safety Tolerance and Pharmacokinetics of Stavudine d4T in Combination With 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 evaluate the safety and tolerance of 2 anti-HIV drugs d4T and 3TC given in combination to HIV-positive pregnant women and their infants
Most HIV-positive pregnant women usually take the anti-HIV drug zidovudine ZDV to treat HIV and reduce the chances of giving HIV to their babies It recently has been shown that a combination of drugs may be more effective than ZDV alone This study tests the effectiveness of combinations of ZDV d4T and 3TC
Most HIV-positive pregnant women usually take the anti-HIV drug zidovudine ZDV to treat HIV and reduce the chances of giving HIV to their babies It recently has been shown that a combination of drugs may be more effective than ZDV alone This study tests the effectiveness of combinations of ZDV d4T and 3TC
Detailed Description:
New antiretroviral agents or combinations are sought that are as efficacious as ZDV and that would be effective in reducing the rate of vertical transmission of HIV in women who have been long-term recipients of ZDV d4T is a good candidate drug It is a thymidine nucleoside analogue that inhibits replication of HIV at concentrations similar to those of ZDV which have anti-HIV activity The demonstrated safety profile of d4T the ease of administration and most importantly preliminary efficacy data especially in combination with 3TC make this an excellent candidate combination for a Phase I perinatal trial
Two cohorts of women and infants are enrolled in this study The first five motherinfant pairs enrolled comprise Group I Mothers enrolled in this group must allow their infants to receive ZDV Eight motherinfant pairs are then enrolled in Group II Group II infants are allocated into two groups those whose mothers allow the administration of ZDV Group IIA and those whose mothers do not Group IIB
Group I
Women
Beginning at a minimum of 14 weeks gestation
1 Oral d4T until the start of active labor
2 Oral 3TC
At the start of active labor defined as regular uterine contractions resulting in cervical dilation 3-4 cm and effacement 50-60 and during delivery
1 d4T administered IV as a loading dose followed by a continuous infusion until the umbilical cord is clamped
2 Oral 3TC if patients previous dose of 3TC was administered at least 05h prior to onset of labor and additional dose of 3TC is administered and the time until next dose is scheduled accordingly
Infants
1 d4T as a single oral dose on Day 6 - 2 days and on Day 42 this dose can be given between Days 35 and 42 inclusive
2 Oral ZDV or IV if unable to take oral dosing for 6 weeks beginning a maximum of 12 hours after birth
3 3TC for 6 weeks beginning a maximum of 12 hours after birth
Group II
Women
Beginning at a minimum of 14 weeks gestation
1 Oral d4T until the umbilical cord is clamped
2 Oral 3TC
At the start of active labor and through delivery
Oral d4T and 3TC as above If the last doses of d4T and 3TC were given at least 05 hours prior to onset of active labor an additional dose of d4T and 3TC is given and repeated every 12 hours
Infant Group IIA
1 d4T as a single oral dose on Day 6 - 2 days and on Day 42 this dose can be given between Days 35 and 42 inclusive
2 Oral ZDV or IV if unable to tolerate oral dosing for 6 weeks beginning a maximum of 12 hours after birth
3 3TC for 6 weeks beginning a maximum of 12 hours after birth
Infant Group IIB
Beginning a maximum of 12 hours after birth
1 d4T for 6 weeks
2 3TC for 6 weeks AS PER AMENDMENT 91597 If tolerated infants continue on protocol treatment to 6 weeks of age At 6 weeks infants should receive standard care including PCP prophylaxis from an HIV specialistpediatrician HIV-infected infants are offered ACTG trial enrollment or open-label treatment based on best clinical judgment of their physician AS PER AMENDMENT 21999 Patients who prematurely discontinue study treatment should continue to be followed on study for the duration of the study
Two cohorts of women and infants are enrolled in this study The first five motherinfant pairs enrolled comprise Group I Mothers enrolled in this group must allow their infants to receive ZDV Eight motherinfant pairs are then enrolled in Group II Group II infants are allocated into two groups those whose mothers allow the administration of ZDV Group IIA and those whose mothers do not Group IIB
Group I
Women
Beginning at a minimum of 14 weeks gestation
1 Oral d4T until the start of active labor
2 Oral 3TC
At the start of active labor defined as regular uterine contractions resulting in cervical dilation 3-4 cm and effacement 50-60 and during delivery
1 d4T administered IV as a loading dose followed by a continuous infusion until the umbilical cord is clamped
2 Oral 3TC if patients previous dose of 3TC was administered at least 05h prior to onset of labor and additional dose of 3TC is administered and the time until next dose is scheduled accordingly
Infants
1 d4T as a single oral dose on Day 6 - 2 days and on Day 42 this dose can be given between Days 35 and 42 inclusive
2 Oral ZDV or IV if unable to take oral dosing for 6 weeks beginning a maximum of 12 hours after birth
3 3TC for 6 weeks beginning a maximum of 12 hours after birth
Group II
Women
Beginning at a minimum of 14 weeks gestation
1 Oral d4T until the umbilical cord is clamped
2 Oral 3TC
At the start of active labor and through delivery
Oral d4T and 3TC as above If the last doses of d4T and 3TC were given at least 05 hours prior to onset of active labor an additional dose of d4T and 3TC is given and repeated every 12 hours
Infant Group IIA
1 d4T as a single oral dose on Day 6 - 2 days and on Day 42 this dose can be given between Days 35 and 42 inclusive
2 Oral ZDV or IV if unable to tolerate oral dosing for 6 weeks beginning a maximum of 12 hours after birth
3 3TC for 6 weeks beginning a maximum of 12 hours after birth
Infant Group IIB
Beginning a maximum of 12 hours after birth
1 d4T for 6 weeks
2 3TC for 6 weeks AS PER AMENDMENT 91597 If tolerated infants continue on protocol treatment to 6 weeks of age At 6 weeks infants should receive standard care including PCP prophylaxis from an HIV specialistpediatrician HIV-infected infants are offered ACTG trial enrollment or open-label treatment based on best clinical judgment of their physician AS PER AMENDMENT 21999 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 |
|---|---|---|---|
| PACTG 332 | Registry Identifier | DAIDS ES | None |
| 11304 | REGISTRY | None | None |