Ignite Creation Date:
2024-05-05 @ 11:23 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00017719
Status:
COMPLETED
Last Update Posted:
2021-11-01
First Post:
2001-06-08
Brief Title:
Combination Treatment With and Without Protease Inhibitors for Women Who Begin Therapy for HIV Infection During Pregnancy
Sponsor:
National Institute of Allergy and Infectious Diseases NIAID
Organization:
National Institute of Allergy and Infectious Diseases NIAID
Study Overview
Official Title:
Randomized Trial of Protease Inhibitor-Including vs Protease Inhibitor-Sparing Regimens for Women Who Initiate Therapy of HIV Infection During Pregnancy
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 best anti-HIV treatment regimen for pregnant women is not known Protease inhibitors PIs are often used but they have side effects that may be harmful for pregnant women It is not known if treatment regimens that do not include PIs are as effective in pregnant women as those that include PIs This trial will compare two anti-HIV treatment plans one with and one without PIs in women who start HIV treatment during pregnancy The study will evaluate the effects of the anti-HIV drugs on the developing infant and prevention of mother-to-child HIV transmission during pregnancy
Detailed Description:
The optimal treatment strategy for women who initiate antiretroviral therapy during pregnancy is not known Although PI-based antiretroviral regimens are prescribed with increasing frequency among pregnant women the efficacy and safety of this approach is unknown Pregnant women are at increased risk for glucose intolerance and insulin resistance PIs are associated with glucose intolerance Physiologic differences between pregnant women and nonpregnant adults may alter the pharmacokinetics of antiretroviral regimens Fetal safety considerations and effects on perinatal HIV transmission must also be considered when selecting an antiretroviral regimen for pregnant women This trial will compare PI-based and PI-sparing antiretroviral regimens for women initiating antiretroviral therapy in pregnancy
Women will be stratified on the basis of viral load 50000 or less copiesml or greater than 50000 copiesml and gestational age at entry 20 or less weeks or greater than 20 weeks and then randomized to one of two treatment groups Group A will receive the PI nelfinavir NFV with zidovudine ZDV and lamivudine d4T Group B will receive nevirapine NVP with ZDV and d4T Women will have clinic visits for physical and obstetrical examinations at 2 4 6 and 8 weeks after entry and then every 4 weeks until delivery After delivery infants in both groups may receive ZDV until they are 6 weeks old Infants are evaluated for safety and to test the infants blood for HIV-1 at birth and at Weeks 2 8 16 and 24
Women will continue on assigned antiretroviral therapy postpartum and will have 11 postpartum clinic visits over a period of 2 years Blood samples from women will be evaluated for safety and for virologic pharmacokinetic and metabolic studies The first 12 women randomized to Group A will undergo a 4-hour pharmacokinetic profile at 32 to 36 weeks gestation and at 8 weeks postpartum to determine the timing of the nelfinavir trough The first 20 women randomized to Group B will undergo an 8-hour pharmacokinetic profile at either 16 to 24 weeks or 32 to 36 weeks gestation and then again at 8 weeks postpartum to characterize pharmacokinetics of nevirapine at steady state in pregnancy and in the postpartum period
Women will be stratified on the basis of viral load 50000 or less copiesml or greater than 50000 copiesml and gestational age at entry 20 or less weeks or greater than 20 weeks and then randomized to one of two treatment groups Group A will receive the PI nelfinavir NFV with zidovudine ZDV and lamivudine d4T Group B will receive nevirapine NVP with ZDV and d4T Women will have clinic visits for physical and obstetrical examinations at 2 4 6 and 8 weeks after entry and then every 4 weeks until delivery After delivery infants in both groups may receive ZDV until they are 6 weeks old Infants are evaluated for safety and to test the infants blood for HIV-1 at birth and at Weeks 2 8 16 and 24
Women will continue on assigned antiretroviral therapy postpartum and will have 11 postpartum clinic visits over a period of 2 years Blood samples from women will be evaluated for safety and for virologic pharmacokinetic and metabolic studies The first 12 women randomized to Group A will undergo a 4-hour pharmacokinetic profile at 32 to 36 weeks gestation and at 8 weeks postpartum to determine the timing of the nelfinavir trough The first 20 women randomized to Group B will undergo an 8-hour pharmacokinetic profile at either 16 to 24 weeks or 32 to 36 weeks gestation and then again at 8 weeks postpartum to characterize pharmacokinetics of nevirapine at steady state in pregnancy and in the postpartum period
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 |
|---|---|---|---|
| 10192 | REGISTRY | None | None |
| ACTG P1022 | None | None | None |
| PACTG P1022 | Registry Identifier | DAIDS ES | None |