Ignite Creation Date:
2024-05-05 @ 5:16 PM
Last Modification Date:
2024-10-26 @ 9:30 AM
Study NCT ID:
NCT00424814
Status:
COMPLETED
Last Update Posted:
2013-07-18
First Post:
2007-01-19
Brief Title:
Prevention of HIV1 Mother to Child Transmission Without Nucleoside Analogue Reverse Transcriptase Inhibitors in the Pre-partum Phase ANRS 135 Primeva
Sponsor:
ANRS Emerging Infectious Diseases
Organization:
ANRS Emerging Infectious Diseases
Study Overview
Official Title:
Prevention of HIV1 Mother to Child Transmission Without Nucleoside Analogue Reverse Transcriptase Inhibitors in the Pre-partum Phase A Multicenter Randomised Phase IIIII Open Label Study With a Group of 100 Pregnant Women Receiving LopinavirRitonavir and a Group of 50 Receiving LopinavirRitonavir Plus Zidovudine and Lamivudine ANRS 135 Primeva
Status:
COMPLETED
Status Verified Date:
2013-07
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:
In the pre-partum phase the use of antiretroviral therapy for the mother during the last trimester of pregnancy is mandatory The use of HAART during pregnancy usually two nucleosides analogues and a protease inhibitor exposes the mother and the child to cumulate toxicities related to both families The aim of this study is to assess the use of a boosted protease inhibitor without nucleoside analogue during the pre-partum phase for women with no indication of antiretroviral therapy for their own
Detailed Description:
Recent data from the French perinatal cohort and others indicate that HIV-RNA levels at delivery correlate with risk of transmission among women treated with antiretroviral agents Most of these treatments include zidovudine alone or in combination Mitochondrial toxicity related to nucleoside analogues exposure zidovudine and lamivudine has been reported in adults and in infants with in utero exposure to these drugs In addition biological markers of genotoxicity on nuclear DNA have recently been shown in exposed newborn These issues raised the concern of the riskbenefit of multiple therapy in the context of mother to child transmission for women who do not meet the standard criteria for antiretroviral therapy In women with CD4350 and VL30 000 copiesml a treatment with lopinavirritonavir should achieve a rapid control of HIV1 viremia below 1000 copiesml without harm in term of resistance In this study we would like to assess under strict control the safety and efficacy of such regimen compared to the same boosted PI zidovudine and lamivudine as standard regimen The treatment will start at 26 weeks of gestation and the follow up will include safety and efficacy parameters as well as pharmacokinetics in plasma and genital tract for the women bloodcord ratio testing for ARV resistance Women will stop their treatment after delivery Infants will be closely monitored up to 24 months with HIV DNA and HIVRNA-PCR for HIV testing and biochemical and haematology usual safety evaluation In addition frozen samples will be collected for specific evaluation of nucleoside analogue foetal mitochondrial and nuclear DNA interactions
In term of transmission safety the end point would be to reach a viral load below 200 copies after 8 weeks of treatment In case of failure this would allow a sufficient delay for a treatment modification ie addition of NRTI and an elective caesarian could be programmed
In term of transmission safety the end point would be to reach a viral load below 200 copies after 8 weeks of treatment In case of failure this would allow a sufficient delay for a treatment modification ie addition of NRTI and an elective caesarian could be programmed
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 |
|---|---|---|---|
| ANRS 135 PRIMEVA | None | None | None |