Ignite Creation Date:
2024-05-05 @ 9:55 PM
Last Modification Date:
2024-10-26 @ 10:11 AM
Study NCT ID:
NCT00993031
Status:
COMPLETED
Last Update Posted:
2019-05-14
First Post:
2009-10-08
Brief Title:
Protease Inhibitors to Reduce Malaria Morbidity in HIV-Infected Pregnant Women
Sponsor:
University of California San Francisco
Organization:
University of California San Francisco
Study Overview
Official Title:
Protease Inhibitors to Reduce Malaria Morbidity in HIV-Infected Pregnant Women
Status:
COMPLETED
Status Verified Date:
2019-04
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:
PROMOTE-PIs
Brief Summary:
This study is an open-label single site randomized controlled trial comparing protease inhibitor PI-based antiretroviral therapy ART to non-PI based ART for HIV-infected pregnant and breastfeeding women of all CD4 cell counts at high risk of malaria The study is designed to test the hypothesis that pregnant women receiving a PI-based ART regimen will have lower risk of placental malaria compared to pregnant women receiving a non-PI based ART regimen The primary study endpoint of the study is placental malaria This study also enrolls the infants of these women at the time of delivery
Detailed Description:
The study site will be the Tororo district hospital campus situated in Eastern Uganda an area of high malaria transmission Using convenience sampling we will enroll 500 HIV-infected pregnant women and their infants from the Tororo community Eligible women between 12-28 weeks gestation will be randomized at enrollment to receive either a PI- based or an NNRTI-based ART regimen after stratification by gravidity G1 versus G2 and gestational age 24 weeks versus 24 weeks at enrollment
Treatment group A will receive Zidovudine 300mg Lamivudine 150mg Lopinavirritonavir 200mg50mg Treatment group B will receive Zidovudine 300mg Lamivudine 150mg Efavirenz 600mg
At enrollment all study participants will receive a long lasting ITN and as available a basic care package including a safe water vessel multivitamins and condoms as per current standard of care for HIV-infected pregnant women in Uganda if they have not already received these interventions from the referral site Two ITNs will be provided for each mother-infant pair Participants will receive all routine and acute medical care at a designated study clinic open 7 days a week from 8 am to 5 pm If medical care is needed after hours participants will be instructed to come to Tororo District Hospital premises where the study clinic is located and request that the study physician on-call be contacted They will be followed up from the time of enrollment during pregnancy and through the cessation of breastfeeding seen monthly for routine assessments and laboratory evaluations Following delivery the infants of enrolled women will be followed until 6 weeks following the cessation of breastfeeding but not beyond 58 weeks of life Study participants will be followed closely for adverse events potentially due to study drugs and for malaria and HIV treatment outcomes During the follow-up period all patients presenting to the clinic with a new episode of fever will undergo standard evaluation history physical examination and Giemsa-stained blood smear for the diagnosis of malaria
Women will receive the study treatment from the time of study entry and randomization 12-28 weeks gestation until 1 week following the cessation of breastfeeding but no longer than 1 year 1 week postpartum If a subject experiences a toxicity endpoint ART will be changed to provide antiviral activity prior to delivery Exclusive breastfeeding will be encouraged until 24 weeks postpartum which is the standard of care in Uganda As per updated WHO guidelines women will be encouraged to introduce food at 6 months of life and continue breastfeeding until 1 year of life Women will be counseled to wean over the course of 1 month and continue antiretrovirals for at least 1 week following weaning Furthermore if an infant is found to be HIV-infected Uganda MOH and WHO guidelines recommend the continuation of breastfeeding until 2 years of life and daily TS All women will receive daily oral trimethoprimsulfamethoxazole TS per Ugandan MOH guidelines
Per Ugandan MOH guidelines all newborns will receive nevirapine syrup 10mgml starting within 12 hours after birth for 6 weeks daily oral TS from 6 weeks of life until 6 weeks following the cessation of breastfeeding and their mothers will be instructed on ITN use for their infants
Treatment group A will receive Zidovudine 300mg Lamivudine 150mg Lopinavirritonavir 200mg50mg Treatment group B will receive Zidovudine 300mg Lamivudine 150mg Efavirenz 600mg
At enrollment all study participants will receive a long lasting ITN and as available a basic care package including a safe water vessel multivitamins and condoms as per current standard of care for HIV-infected pregnant women in Uganda if they have not already received these interventions from the referral site Two ITNs will be provided for each mother-infant pair Participants will receive all routine and acute medical care at a designated study clinic open 7 days a week from 8 am to 5 pm If medical care is needed after hours participants will be instructed to come to Tororo District Hospital premises where the study clinic is located and request that the study physician on-call be contacted They will be followed up from the time of enrollment during pregnancy and through the cessation of breastfeeding seen monthly for routine assessments and laboratory evaluations Following delivery the infants of enrolled women will be followed until 6 weeks following the cessation of breastfeeding but not beyond 58 weeks of life Study participants will be followed closely for adverse events potentially due to study drugs and for malaria and HIV treatment outcomes During the follow-up period all patients presenting to the clinic with a new episode of fever will undergo standard evaluation history physical examination and Giemsa-stained blood smear for the diagnosis of malaria
Women will receive the study treatment from the time of study entry and randomization 12-28 weeks gestation until 1 week following the cessation of breastfeeding but no longer than 1 year 1 week postpartum If a subject experiences a toxicity endpoint ART will be changed to provide antiviral activity prior to delivery Exclusive breastfeeding will be encouraged until 24 weeks postpartum which is the standard of care in Uganda As per updated WHO guidelines women will be encouraged to introduce food at 6 months of life and continue breastfeeding until 1 year of life Women will be counseled to wean over the course of 1 month and continue antiretrovirals for at least 1 week following weaning Furthermore if an infant is found to be HIV-infected Uganda MOH and WHO guidelines recommend the continuation of breastfeeding until 2 years of life and daily TS All women will receive daily oral trimethoprimsulfamethoxazole TS per Ugandan MOH guidelines
Per Ugandan MOH guidelines all newborns will receive nevirapine syrup 10mgml starting within 12 hours after birth for 6 weeks daily oral TS from 6 weeks of life until 6 weeks following the cessation of breastfeeding and their mothers will be instructed on ITN use for their infants
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 |
|---|---|---|---|
| H5741-34342 and 10-02958 | OTHER | UCSF Committee on Human Research | httpsreporternihgovquickSearchP01HD059454 |
| P01HD059454 | NIH | None | None |
| 2009-141 | OTHER | None | None |
| HS-670 | OTHER | None | None |
| 592ESRNDADID-092009 | OTHER | None | None |