Ignite Creation Date:
2024-05-05 @ 5:12 PM
Last Modification Date:
2024-10-26 @ 9:29 AM
Study NCT ID:
NCT00409591
Status:
TERMINATED
Last Update Posted:
2016-01-28
First Post:
2006-12-08
Brief Title:
MaternalInfant Peripartum NVP Versus Infant Only Peripartum NVP or Maternal LPVr in Addition to Standard ZDV Prophylaxis for the Prevention of Perinatal PMTCT HIV in Thailand
Sponsor:
Institut de Recherche pour le Developpement
Organization:
Institut de Recherche pour le Developpement
Study Overview
Official Title:
Maternal and Infant Peripartum Nevirapine Versus Infant Only Peripartum Nevirapine or Maternal LopinavirRitonavir in Addition to Standard Zidovudine Prophylaxis for the Prevention of Perinatal HIV in Thailand
Status:
TERMINATED
Status Verified Date:
2016-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Change in National PMTCT guidelines in Thailand
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PHPT-5
Brief Summary:
The purpose of this study is to compare the efficacy of two doses of nevirapine NVP given only to the infants or lopinavirritonavir LPVr from 28 weeks gestation with single dose SD NVP given to the mothers plus two doses to the infants in addition to zidovudine ZDV prophylaxis from 28 weeks gestation and for one week of ZDV in neonates for the prevention of mother-to-child transmission of HIV-1
Detailed Description:
Multicenter placebo-controlled double blind clinical trial where non immunocompromised women receiving the ZDV prophylaxis regimen from 28 weeks gestation as recommended in Thailand will be randomized to one of two arms
Arm 1 NVP-NVP
In women one NVP 200 mg tablet at onset of labor
In neonates NVP oral suspension 6 mg in the delivery room immediately after birth plus a second dose between 48 and 72 hours
Arm 2 PL-NVP
In women one placebo tablet at onset of labor
In neonates NVP oral suspension 6 mg in the delivery room immediately after birth plus a second dose between 48 and 72 hours
Arm 3 LPVr
In women LPVr 400100 mg bid from 28 weeks gestation until delivery
women in Arm 1 will also receive 7-day ZDV 300mg bid plus 3TC 150mg bid from delivery women in Arm 2 will also receive 7-day ZDV3TC Placebo from delivery If the new born weight less than 2500 g nevirapine will be administered 2 mg1 kg As per Thai Guideline
All infants will receive ZDV for at least one week Follow-up of women and infants is carried out on an outpatient basis except for delivery and the first three days after delivery Mothers and infants are followed-up for 24 months after delivery
Note The study was stopped and data unblinded upon DSMB recommendations in September 2010 because of changes in Thai PMTCT guidelines recommending use of HAART in all HIV infected pregnant women regardless of their CD4 count At the time of unblinding 435 pregnant women had been enrolled and follow-up of these women and their children is continuing
Arm 1 NVP-NVP
In women one NVP 200 mg tablet at onset of labor
In neonates NVP oral suspension 6 mg in the delivery room immediately after birth plus a second dose between 48 and 72 hours
Arm 2 PL-NVP
In women one placebo tablet at onset of labor
In neonates NVP oral suspension 6 mg in the delivery room immediately after birth plus a second dose between 48 and 72 hours
Arm 3 LPVr
In women LPVr 400100 mg bid from 28 weeks gestation until delivery
women in Arm 1 will also receive 7-day ZDV 300mg bid plus 3TC 150mg bid from delivery women in Arm 2 will also receive 7-day ZDV3TC Placebo from delivery If the new born weight less than 2500 g nevirapine will be administered 2 mg1 kg As per Thai Guideline
All infants will receive ZDV for at least one week Follow-up of women and infants is carried out on an outpatient basis except for delivery and the first three days after delivery Mothers and infants are followed-up for 24 months after delivery
Note The study was stopped and data unblinded upon DSMB recommendations in September 2010 because of changes in Thai PMTCT guidelines recommending use of HAART in all HIV infected pregnant women regardless of their CD4 count At the time of unblinding 435 pregnant women had been enrolled and follow-up of these women and their children is continuing
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 |
|---|---|---|---|
| R01HD056953 | NIH | None | httpsreporternihgovquickSearchR01HD056953 |
| R01HD052461 | NIH | None | None |