HIV-1 InfectionPhase 2ANRS 160 RalFENCT02099474
Evaluation of Raltegravir During the Third Trimester of Pregnancy
A Phase 2 study testing Study of pharmacokinetic properties of raltegravir during the 3rd trimester of pregnancy in people with HIV-1 Infection and PREGNANCY, run by ANRS, Emerging Infectious Diseases at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- HIV-1 Infection, PREGNANCY
- What is being tested?
- Study of pharmacokinetic properties of raltegravir during the 3rd trimester of pregnancy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 83 participants
- Where
- 1 siteFrance
- Study dates
- 30 Jun 2014to Apr 2017
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of the Pharmacokinetic Properties and the Tolerance of Raltegravir During the Third Trimester of Pregnancy
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.
Read the detailed description
- Objectives
- 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.
- 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
- Methodology
- National multicenter pharmacokinetic study conducted among pregnant women infected by HIV-1 and exposed to raltegravir during pregnancy.
- 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).
- Conditions
- HIV-1 Infection, PREGNANCY
- Being tested
- Study of pharmacokinetic properties of raltegravir during the 3rd trimester of pregnancy
- Keywords
- HIV-1, HIV mother to child prevention, Raltegravir, Pharmacokinetic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Study of pharmacokinetic properties of raltegravir during the 3rd trimester of pregnancyOther
Also called raltegravir (Isentress®)
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)
| Study group | Role | What they receive |
|---|---|---|
| Raltegravir | Experimental | All women have been prescribed raltegravir before study participation. Receives: Other: Study of pharmacokinetic properties of raltegravir during the 3rd trimester of pregnancy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison of the AUC and raltegravir trough concentration during and after pregnancy
Measured: 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)
Secondary outcomes (7)
Estimation of placental transfer of raltegravir
Cmin, Cmax, AUC, t1/2 of raltegravir in newborns.
Measured: Up to 72 hours after delivery
Study of genetic polymorphism which could modify raltegravir concentrations
Measured: Up to 72 hours after delivery
Proportion of women having a viral load < 50 cp/mL at delivery
Measured: Up to 72 hours after delivery
Proportion of maternal-to-child HIV transmission
Measured: Up to 72 hours after delivery
Untimely stop of raltegravir for toxicity or intolerance
Measured: 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.
Measured: Month 6
Estimation of neonatal elimination of raltegravir
Cmin, Cmax, AUC, t1/2 of raltegravir in newborns.
Measured: Up to 72 hours after delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Mar 2014 (estimated)
- Study start30 Jun 2014
- Primary completionJan 2017
- Study completionApr 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HIV-1 InfectionStudies of the same condition, open and under way.
- More trials run by ANRS, Emerging Infectious DiseasesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 83 participants (actual)
Sponsor and investigators
- Lead sponsor
- ANRS, Emerging Infectious Diseases
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- JADE GHOSN, MD, Principal investigator, CHU Hôtel Dieu PARIS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02099474
- Sponsor's protocol ID
- ANRS 160 RalFE
- Other IDs
- 2013-004571-12
- Acronym
- ANRS 160 RalFE
- Status last verified
- Aug 2017
- First submitted
- 19 Mar 2014
- Last updated
- 22 Aug 2017
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 32661003
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Pharmacokinetic Properties and the Tolerance of Raltegravir During the Third Trimester of Pregnancy
- ClinicalTrials.gov ID
- NCT02099474
- Acronym / sponsor ID
- ANRS 160 RalFE / ANRS 160 RalFE
- Conditions
- HIV-1 Infection, PREGNANCY
- Keywords
- HIV-1, HIV mother to child prevention, Raltegravir, Pharmacokinetic
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 83 participants (actual)
- Lead sponsor
- ANRS, Emerging Infectious DiseasesOther government
- Study start
- 30 Jun 2014 (actual)
- Primary completion
- Jan 2017 (actual)
- Study completion
- Apr 2017 (actual)
- First posted
- 31 Mar 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
- Objectives
- 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.
- 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
- Methodology
- National multicenter pharmacokinetic study conducted among pregnant women infected by HIV-1 and exposed to raltegravir during pregnancy.
- 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).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Raltegravir | Experimental | Other: Study of pharmacokinetic properties of raltegravir during the 3rd trimester of pregnancyAll women have been prescribed raltegravir before study participation. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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)
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Study of pharmacokinetic properties of raltegravir during the 3rd trimester of pregnancyAlso: raltegravir (Isentress®)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 | Raltegravir |
Primary outcome
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)
7 secondary outcomes
Estimation of placental transfer of raltegravir
Time frame: Up to 72 hours after delivery
Study of genetic polymorphism which could modify raltegravir concentrations
Time frame: Up to 72 hours after delivery
Proportion of women having a viral load < 50 cp/mL at delivery
Time frame: Up to 72 hours after delivery
Proportion of maternal-to-child HIV transmission
Time frame: Up to 72 hours after delivery
Untimely stop of raltegravir for toxicity or intolerance
Time frame: 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.
Time frame: Month 6
Estimation of neonatal elimination of raltegravir
Time frame: Up to 72 hours after delivery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Aug 2017.
- Derived from this study: PubMed 32661003Zheng 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
JADE GHOSN, MD principal investigator
CHU Hôtel Dieu PARIS
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Study of pharmacokinetic properties of raltegravir during the 3rd trimester of pregnancy in people with HIV-1 Infection and PREGNANCY, run by ANRS, Emerging Infectious Diseases at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02099474, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Aug 2017.