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Evaluation of Raltegravir During the Third Trimester of Pregnancy

Information source: French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS)
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: HIV-1 Infection; PREGNANCY

Intervention: Study of pharmacokinetic properties of raltegravir during the 3rd trimester of pregnancy (Other)

Phase: Phase 2

Status: Recruiting

Sponsored by: French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS)

Official(s) and/or principal investigator(s):
JADE GHOSN, MD, Principal Investigator, Affiliation: CHU Hôtel Dieu PARIS

Overall contact:
Jade GHOSN, MD, Phone: 33 1 42348836, Email: jade.ghosn@htd.aphp.fr

Summary

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.

Clinical Details

Official title: Evaluation of the Pharmacokinetic Properties and the Tolerance of Raltegravir During the Third Trimester of Pregnancy

Study design: Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Comparison of the AUC and raltegravir trough concentration during and after pregnancy

Secondary outcome:

Estimation of placental transfer of raltegravir

Study of genetic polymorphism which could modify raltegravir concentrations

Proportion of women having a viral load < 50 cp/mL at delivery

Proportion of maternal-to-child HIV transmission

Untimely stop of raltegravir for toxicity or intolerance

Clinical and biological anomaly occurring during the third trimester of pregnancy and during the first 6 months of life of the neonate.

Estimation of neonatal elimination of raltegravir

Detailed description: 1. Objectives 1. Principal objective

- To study pharmacokinetic properties of raltegravir in pregnant women infected

by HIV-1, during the third trimester of pregnancy (between 30 and 37 weeks of amenorrhea) and 1 month after childbirth (between W4 and W6 postpartum), as well as in their neonate. 2. Secondary objectives

- Estimate the frequency of women receiving raltegravir and having indetectable

viral load at delivery (and those having a strictly indetectable viral load, with no signal under the threshold of the technique used).

- Describe the tolerance to raltegravir in pregnant women during the third

trimester and in her neonates 2. Methodology

- National multicenter pharmacokinetic study conducted among pregnant women infected

by HIV-1 and exposed to raltegravir during pregnancy. 3. Statistical method

- Method of population pharmacokinetic with 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).

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Female.

Criteria:

Inclusion Criteria:

- Pregnant woman, between 30 and 37 weeks of amenorrhea

- 18 years old and over

- Infected by HIV-1

- Receiving a therapeutic combination, stable for at least 15 days before inclusion,

with raltegravir at the standard dose (400 mg twice daily) which the doctor plans to maintain till the end of pregnancy and at least one month after delivery

- Informed consent signed by mother and investigator (at the latest day of

pre-inclusion and before any examination conducted as part of research)

- Affiliated person or beneficiary of a social security system (medical aid of state or

AME is not a social security system)

- Participant agreeing to be registered in the national file of the people who

participate in biomedical researches Exclusion Criteria:

- Infected by HIV-2

- Under 18 years old

- Receiving therapeutic association with atazanavir (Reyataz®), fosamprenavir

(Telzir®), or efavirenz ( contained in Sustiva® and Atripla®)

- Currently using medication, drugs or alcohol which can interfere with the research:

rifampicine, phénobarbital, phénytoïne, topical gastrointestinal, antiacid and adsorbents

- Presenting a clinical situation or acute pathology incompatible with the realisation

of a pharmacokinetic study.

- Planned absence which could hinder research participation (travel abroad, moving,

imminent transfer ...)

- Participating in another research, except the French perinatal survey (ANRS CO1 EPF

or ANRS CO11 observatory), including an exclusion period still in progress at the pre-inclusion

- Person under guardianship, or deprived of freedom by a judicial or administrative

decision

Locations and Contacts

Jade GHOSN, MD, Phone: 33 1 42348836, Email: jade.ghosn@htd.aphp.fr

CHU Hôtel Dieu, Paris 75004, France; Recruiting
JADE GHOSN, MD, Phone: 33 1 42348836
Additional Information

Starting date: July 2014
Last updated: July 23, 2015

Page last updated: August 23, 2015

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