Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 2013-004571-12 | EudraCT Number |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The purpose of this study is to assess the evolution of raltegravir concentration in the mother (between the 3rd trimester of pregnancy and one month post-delivery) and her neonate, when this drug is used to prevent mother-to-child HIV-1 transmission as part of a combined antiretroviral regimen.
Objectives
Principal objective
Secondary objectives
Methodology
Statistical method
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Raltegravir | Experimental | All women have been prescribed raltegravir before study participation. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Study of pharmacokinetic properties of raltegravir during the 3rd trimester of pregnancy | Other | Introduction of a catheter for performing 5 blood samples in pregnant women infected by HIV-1, before the raltegravir intake, 0.5, 3, 8 and 12 hours after the intake at each of two visits (between 30 and 37 weeks of amenorrhea, and 4 to 6 weeks after delivery) |
| Measure | Description | Time Frame |
|---|---|---|
| Comparison of the AUC and raltegravir trough concentration during and after pregnancy | 5 samples: before the drug intake, 0.5, 3, 8 and 12 hours after the intake at each of the 2 visits (between 30 and 37 weeks of amenorrhea, and 4 to 6 weeks after delivery) |
| Measure | Description | Time Frame |
|---|---|---|
| Estimation of placental transfer of raltegravir | Cmin, Cmax, AUC, t1/2 of raltegravir in newborns. | Up to 72 hours after delivery |
| Study of genetic polymorphism which could modify raltegravir concentrations |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| JADE GHOSN, MD | CHU Hôtel Dieu PARIS | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU Hôtel Dieu | Paris | 75004 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32661003 | Derived | Zheng Y, Hirt D, Delmas S, Lui G, Benaboud S, Lechedanec J, Treluyer JM, Chenevier-Gobeaux C, Arezes E, Gelley A, Amri I, Urien S, Bouazza N, Foissac F, Warszawski J, Ghosn J. Effect of Pregnancy on Unbound Raltegravir Concentrations in the ANRS 160 RalFe Trial. Antimicrob Agents Chemother. 2020 Sep 21;64(10):e00759-20. doi: 10.1128/AAC.00759-20. Print 2020 Sep 21. |
Not provided
Not provided
| Type | Date | Date Unknown |
|---|---|---|
| Release | Nov 5, 2021 | |
| Reset | Jan 7, 2022 |
Not provided
Not provided
| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Nov 5, 2021 | Jan 7, 2022 |
| ID | Term |
|---|---|
| D000068898 | Raltegravir Potassium |
| ID | Term |
|---|---|
| D011760 | Pyrrolidinones |
| D011759 | Pyrrolidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
|
| Up to 72 hours after delivery |
| Proportion of women having a viral load < 50 cp/mL at delivery | Up to 72 hours after delivery |
| Proportion of maternal-to-child HIV transmission | Up to 72 hours after delivery |
| Untimely stop of raltegravir for toxicity or intolerance | Up to 72 hours after delivery |
| Clinical and biological anomaly occurring during the third trimester of pregnancy and during the first 6 months of life of the neonate. | Number of newborns with adverse events as a measure of safety and tolerability. Newborns will be followed up to 24 weeks of age. | Month 6 |
| Estimation of neonatal elimination of raltegravir | Cmin, Cmax, AUC, t1/2 of raltegravir in newborns. | Up to 72 hours after delivery |