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Evaluation of Raltegravir During the Third Trimester of Pregnancy (ANRS 160 RalFE)

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2014 by French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS)
Sponsor:
Information provided by (Responsible Party):
French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS)
ClinicalTrials.gov Identifier:
NCT02099474
First received: March 19, 2014
Last updated: October 28, 2014
Last verified: October 2014
  Purpose

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.


Condition Intervention Phase
HIV-1 Infection
PREGNANCY
Other: Study of pharmacokinetic properties of raltegravir during the 3rd trimester of pregnancy
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Pharmacokinetics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Evaluation of the Pharmacokinetic Properties and the Tolerance of Raltegravir During the Third Trimester of Pregnancy

Resource links provided by NLM:


Further study details as provided by French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS):

Primary Outcome Measures:
  • Comparison of the AUC and raltegravir trough concentration during and after pregnancy [ Time Frame: 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) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Estimation of placental transfer of raltegravir [ Time Frame: Up to 72 hours after delivery ] [ Designated as safety issue: No ]
    Cmin, Cmax, AUC, t1/2 of raltegravir in newborns.

  • Study of genetic polymorphism which could modify raltegravir concentrations [ Time Frame: Up to 72 hours after delivery ] [ Designated as safety issue: No ]
  • Proportion of women having a viral load < 50 cp/mL at delivery [ Time Frame: Up to 72 hours after delivery ] [ Designated as safety issue: No ]
  • Proportion of maternal-to-child HIV transmission [ Time Frame: Up to 72 hours after delivery ] [ Designated as safety issue: No ]
  • Untimely stop of raltegravir for toxicity or intolerance [ Time Frame: Up to 72 hours after delivery ] [ Designated as safety issue: No ]
  • Clinical and biological anomaly occurring during the third trimester of pregnancy and during the first 6 months of life of the neonate. [ Time Frame: Month 6 ] [ Designated as safety issue: No ]
    Number of newborns with adverse events as a measure of safety and tolerability. Newborns will be followed up to 24 weeks of age.

  • Estimation of neonatal elimination of raltegravir [ Time Frame: Up to 72 hours after delivery ] [ Designated as safety issue: No ]
    Cmin, Cmax, AUC, t1/2 of raltegravir in newborns.


Estimated Enrollment: 72
Study Start Date: July 2014
Estimated Study Completion Date: September 2016
Estimated Primary Completion Date: March 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Raltegravir
All women have been prescribed raltegravir before study participation.
Other: Study of pharmacokinetic properties of raltegravir during the 3rd trimester of pregnancy
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)
Other Name: raltegravir (Isentress®)

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02099474

Contacts
Contact: Jade GHOSN, MD 33 1 42348836 jade.ghosn@htd.aphp.fr
Contact: Sandrine DELMAS 33 1 49595316

Locations
France
CHU Hôtel Dieu Recruiting
Paris, France, 75004
Contact: JADE GHOSN, MD    33 1 42348836      
Sponsors and Collaborators
French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS)
Investigators
Principal Investigator: JADE GHOSN, MD CHU Hôtel Dieu PARIS
  More Information

No publications provided

Responsible Party: French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS)
ClinicalTrials.gov Identifier: NCT02099474     History of Changes
Other Study ID Numbers: ANRS 160 RalFE, 2013-004571-12
Study First Received: March 19, 2014
Last Updated: October 28, 2014
Health Authority: France: Agence Nationale de Sécurité du Médicament et des produits de santé

Keywords provided by French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS):
HIV-1
HIV mother to child prevention
Raltegravir
Pharmacokinetic

ClinicalTrials.gov processed this record on November 25, 2014