HIVNCT02269462
A Study to Evaluate the Effects of Genetic Factors on the Pharmacokinetics of Antiretroviral Drugs During Pregnancy and Lactation
An observational study of HIV and Pregnancy, run by Adeniyi Olagunju at 3 sites in Nigeria.
Trial summary
Mother-to-child transmission of HIV (MTCT) during pregnancy and breastfeeding is prevented with maternal antiretroviral drugs (ARV) and infant nevirapine post-exposure prophylaxis (PEP). However, the pharmacokinetics of certain ARVs is associated with marked inter-individual variability. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- HIV, Pregnancy, Breastfeeding
- What is being tested?
- Efavirenz and Nevirapine
- How many people
- 460 participants
- Where
- 3 sitesNigeria
- Study dates
- Dec 2012to Nov 2013
- Phase
- Observational
- 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
Study population: HIV positive pregnant women and nursing mothers taking efavirenz or nevirapine as part of HAART to prevent mother-to-child transmission of HIV and/or for their own health and their breastfed infants.
Who may be able to join
- HIV positive
- breastfeeding
- enrolled in PMTCT programme
- started efavirenz- or nevirapine-containing regimen during pregnancy
Who cannot join
- exclusive replacement feeding
- mixed feeding before 6 months
- severe maternal or infant illness
- maternal or infant treatment with other drugs or herbal medication with known or uncertain interaction with study drug
Trial locations and contacts
3 sites in 1 country.
Nigeria3 sites
St Monica's Hospital
Adikpo, Benue State
Bishop Murray Medical Centre
Makurdi, Benue State
St Mary's Hospital
Okpoga, Benue State
About this study
Official title: Role of Pharmacogenetics in Efavirenz and Nevirapine Pharmacokinetics, Efficacy and Safety in Mother-infant Pairs During Pregnancy and Lactation
Mother-to-child transmission of HIV (MTCT) during pregnancy and breastfeeding is prevented with maternal antiretroviral drugs (ARV) and infant nevirapine post-exposure prophylaxis (PEP). However, the pharmacokinetics of certain ARVs is associated with marked inter-individual variability. This variability has been associated with single nucleotide polymorphisms (SNPs) in genes encoding metabolising enzymes, transporters and transcriptional regulators. Pregnancy is also associated with additional changes in pharmacokinetics. The resulting sub-therapeutic or supra-therapeutic drug exposures may have serious consequences for virological control, MTCT, emergence of drug resistance, and toxicity. Foetal and infant exposure to maternal ARV during pregnancy and breastfeeding is believed to play a role in the prevention of mother-to-child transmission of HIV (PMTCT). However, such exposures may also result in toxicity. For example, efavirenz is contraindicated in children less than 3 years old or 10kg but transferred to breastfed babies through breast milk. On the other hand, double exposure to nevirapine from breast milk and PEP may also predispose breastfed infants to nevirapine-associated toxicity.
In the proposed study, the influence of selected SNPs in certain drug disposition genes on the pharmacokinetics of efavirenz and nevirapine during pregnancy and lactation, as well as the level of infant exposure to both drugs through breast milk, will be studied. Mathematical models will be developed to predict potential dose optimisation strategies during pregnancy, and to predict infant exposure to maternal drugs through breast milk.
Read the detailed description
Study design: This is an observational study that will be conducted in two phases. In the preliminary phase, associations between selected SNPs in drug disposition genes and mid-dose plasma and breast milk efavirenz and nevirapine concentrations will be explored in an unselected cohort of HIV positive pregnant women and nursing mothers and their breastfed infants taking either drug as part of combination antiretroviral therapy for PMTCT. In the second phase, the SNP independently associated with the highest predictive power will be used to stratify pregnant women and mother-infant pairs into three groups: non-carriers, heterozygotes, and homozygotes. Randomly selected pregnant women or mother-infant pairs from each group were re-recruited and invited for the intensive pharmacokinetic phase.
Samples collection: In the preliminary phase, mid-dose paired dried blood spots (DBS) (and dried breast milk spots in nursing mothers) samples will be collected at a single, recorded time point post dose. In the intensive pharmacokinetic phase, DBS (and dried breast milk spots in nursing mothers) samples will be collected at multiple time points after an observed dose of efavirenz or nevirapine. Samples will be shipped at room temperature to the Department of Molecular and Clinical Pharmacology, University of Liverpool, United Kingdom for analysis.
DNA extraction and SNP genotyping: Genomic DNA will be extracted using available commercial kits in accordance with the manufacture's protocol and genotyping will be performed by allelic discrimination real-time polymerase chain reaction using TaqMan® chemistry-based assays.
Drug quantification and pharmacokinetic analysis: Liquid chromatography-mass spectrometry methods will be developed for the quantification of efavirenz and nevirapine in DBS and dried breast milk spots. Pharmacokinetic parameters will be determined using standard procedures.
- Conditions
- HIV, Pregnancy, Breastfeeding
- Being tested
- Efavirenz, Nevirapine
- Medical subject headings
- Breast Feeding
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EfavirenzDrug
600 mg once daily in combination with other drugs (e.g. tenofovir and emtricitabine)
NevirapineDrug
200 mg twice daily in combination with other drugs (e.g. tenofovir and emtricitabine)
| Study group | Role | What they receive |
|---|---|---|
| Pregnant women - efavirenz | Pregnant women taking 600 mg efavirenz daily as part of combination antiretroviral therapy for PMTCT and for their own health Receives: Drug: Efavirenz | |
| Nursing mothers - efavirenz | Nursing mothers taking 600 mg efavirenz daily as part of combination antiretroviral therapy for PMTCT and for their own health and their breastfed babies Receives: Drug: Efavirenz | |
| Pregnant women - nevirapine | Pregnant women taking 200 mg nevirapine twice daily as part of combination antiretroviral therapy for PMTCT and for their own health Receives: Drug: Nevirapine | |
| Nursing mothers - nevirapine | Nursing mothers taking 200 mg nevirapine twice daily as part of combination antiretroviral therapy for PMTCT and for their own health and their breastfed babies Receives: Drug: Nevirapine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clearance over systemic availability (Cl/F) during pregnancy.
Measured: Patients will be followed for an average of 6 months for the preliminary and intensive pharmacokinetic phase which will occur mainly between the second and third trimester of pregnancy.
Area under the concentration-time curve (AUC0-24 for efavirenz, AUC0-12 for nevirapine) during pregnancy.
Measured: Patients will be followed for an average of 6 months for the preliminary and intensive pharmacokinetic phase which will occur mainly between the second and third trimester of pregnancy.
Minimum plasma drug concentration (Cmin) during pregnancy.
Measured: Patients will be followed for an average of 6 months for the preliminary and intensive pharmacokinetic phase which will occur mainly between the second and third trimester of pregnancy.
Maximum plasma drug concentration (Cmax) during pregnancy.
Measured: Patients will be followed for an average of 6 months for the preliminary and intensive pharmacokinetic phase which will occur mainly between the second and third trimester of pregnancy.
Plasma and breast milk clearance over systemic availability (Cl/F) during lactation.
Measured: Pharmacokinetic visits in the preliminary or intensive pharmacokinetic phase will occur mainly from 1 week to 26 weeks postpartum.
Plasma and breast milk area under the concentration-time curve (AUC0-24 for efavirenz, AUC0-12 for nevirapine) during lactation.
Measured: Pharmacokinetic visits in the preliminary or intensive pharmacokinetic phase will occur mainly from 1 week to 26 weeks postpartum.
Plasma and breast milk minimum drug concentration (Cmin) during lactation.
Measured: Pharmacokinetic visits in the preliminary or intensive pharmacokinetic phase will occur mainly from 1 week to 26 weeks postpartum.
Plasma and breast milk maximum plasma drug concentration (Cmax) during lactation.
Measured: Pharmacokinetic visits in the preliminary or intensive pharmacokinetic phase will occur mainly from 1 week to 26 weeks postpartum.
Secondary outcomes (2)
Rate of mother-to-child transmission of HIV.
Measured: Infants will be followed up from birth until 18 months of age when all exposure to breastfeeding would have stopped.
Effect of pregnancy on CD4 count change (immunological recovery).
Measured: CD4 counts will be determined every 6 months during pregnancy and postpartum, starting from recruitmnent.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Oct 2014 (estimated)
- Study startDec 2012
- Primary completionOct 2013
- Study completionNov 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for HIVStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 460 participants (actual)
Sponsor and investigators
- Lead sponsor
- Adeniyi Olagunju
- Sponsor type
- University, hospital or other
- Collaborators
- University of Liverpool, Obafemi Awolowo University Teaching Hospital
- Responsible party
- Sponsor-investigator, Adeniyi Olagunju, Obafemi Awolowo University
- Investigators
- Adeniyi Olagunju, Principal investigator, Obafemi Awolowo University, NigeriaAndrew Owen, PhD, Principal investigator, University of Liverpool, United Kingdom
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02269462
- Sponsor's protocol ID
- BC60000
- Status last verified
- Sep 2017
- First submitted
- 2 Oct 2014
- Last updated
- 6 Sep 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
Olagunju A, Bolaji OO, Amara A, Waitt C, Else L, Soyinka J, Adeagbo B, Adejuyigbe E, Siccardi M, Back D, Owen A, Khoo S. Development, validation and clinical application of a novel method for the quantification of efavirenz in dried breast milk spots using LC-MS/MS. J Antimicrob Chemother. 2015 Feb;70(2):555-61. doi: 10.1093/jac/dku420. Epub 2014 Oct 17.
PubMed 25326089Olagunju A, Amara A, Waitt C, Else L, Penchala SD, Bolaji O, Soyinka J, Siccardi M, Back D, Owen A, Khoo S. Validation and clinical application of a method to quantify nevirapine in dried blood spots and dried breast-milk spots. J Antimicrob Chemother. 2015 Oct;70(10):2816-22. doi: 10.1093/jac/dkv174. Epub 2015 Jun 24.
PubMed 26108608Olagunju A, Bolaji O, Amara A, Else L, Okafor O, Adejuyigbe E, Oyigboja J, Back D, Khoo S, Owen A. Pharmacogenetics of pregnancy-induced changes in efavirenz pharmacokinetics. Clin Pharmacol Ther. 2015 Mar;97(3):298-306. doi: 10.1002/cpt.43. Epub 2015 Jan 20.
PubMed 25669165Olagunju A, Bolaji O, Amara A, Waitt C, Else L, Adejuyigbe E, Siccardi M, Back D, Khoo S, Owen A. Breast milk pharmacokinetics of efavirenz and breastfed infants' exposure in genetically defined subgroups of mother-infant pairs: an observational study. Clin Infect Dis. 2015 Aug 1;61(3):453-63. doi: 10.1093/cid/civ317. Epub 2015 Apr 16.
PubMed 25882300Olagunju A, Bolaji O, Neary M, Back D, Khoo S, Owen A. Pregnancy affects nevirapine pharmacokinetics: evidence from a CYP2B6 genotype-guided observational study. Pharmacogenet Genomics. 2016 Aug;26(8):381-9. doi: 10.1097/FPC.0000000000000227.
PubMed 27195527Olagunju A, Khoo S, Owen A. Pharmacogenetics of nevirapine excretion into breast milk and infants' exposure through breast milk versus postexposure prophylaxis. Pharmacogenomics. 2016 Jun;17(8):891-906. doi: 10.2217/pgs-2015-0016. Epub 2016 Jun 7.
PubMed 27268507Waitt C, Diliiy Penchala S, Olagunju A, Amara A, Else L, Lamorde M, Khoo S. Development, validation and clinical application of a method for the simultaneous quantification of lamivudine, emtricitabine and tenofovir in dried blood and dried breast milk spots using LC-MS/MS. J Chromatogr B Analyt Technol Biomed Life Sci. 2017 Aug 15;1060:300-307. doi: 10.1016/j.jchromb.2017.06.012. Epub 2017 Jun 17.
PubMed 28651173
Study at a glance
From the registry record, last updated by the sponsor on 6 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role of Pharmacogenetics in Efavirenz and Nevirapine Pharmacokinetics, Efficacy and Safety in Mother-infant Pairs During Pregnancy and Lactation
- ClinicalTrials.gov ID
- NCT02269462
- Acronym / sponsor ID
- BC60000
- Conditions
- HIV, Pregnancy, Breastfeeding
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 460 participants (actual)
- Lead sponsor
- Adeniyi OlagunjuUniversity, hospital or other
- Collaborators
- University of Liverpool, Obafemi Awolowo University Teaching Hospital
- Study start
- Dec 2012
- Primary completion
- Oct 2013 (actual)
- Study completion
- Nov 2013 (actual)
- First posted
- 21 Oct 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.
Mother-to-child transmission of HIV (MTCT) during pregnancy and breastfeeding is prevented with maternal antiretroviral drugs (ARV) and infant nevirapine post-exposure prophylaxis (PEP). However, the pharmacokinetics of certain ARVs is associated with marked inter-individual variability. This variability has been associated with single nucleotide polymorphisms (SNPs) in genes encoding metabolising enzymes, transporters and transcriptional regulators. Pregnancy is also associated with additional changes in pharmacokinetics. The resulting sub-therapeutic or supra-therapeutic drug exposures may have serious consequences for virological control, MTCT, emergence of drug resistance, and toxicity. Foetal and infant exposure to maternal ARV during pregnancy and breastfeeding is believed to play a role in the prevention of mother-to-child transmission of HIV (PMTCT). However, such exposures may also result in toxicity. For example, efavirenz is contraindicated in children less than 3 years old or 10kg but transferred to breastfed babies through breast milk. On the other hand, double exposure to nevirapine from breast milk and PEP may also predispose breastfed infants to nevirapine-associated toxicity.
In the proposed study, the influence of selected SNPs in certain drug disposition genes on the pharmacokinetics of efavirenz and nevirapine during pregnancy and lactation, as well as the level of infant exposure to both drugs through breast milk, will be studied. Mathematical models will be developed to predict potential dose optimisation strategies during pregnancy, and to predict infant exposure to maternal drugs through breast milk.
Detailed description
Study design: This is an observational study that will be conducted in two phases. In the preliminary phase, associations between selected SNPs in drug disposition genes and mid-dose plasma and breast milk efavirenz and nevirapine concentrations will be explored in an unselected cohort of HIV positive pregnant women and nursing mothers and their breastfed infants taking either drug as part of combination antiretroviral therapy for PMTCT. In the second phase, the SNP independently associated with the highest predictive power will be used to stratify pregnant women and mother-infant pairs into three groups: non-carriers, heterozygotes, and homozygotes. Randomly selected pregnant women or mother-infant pairs from each group were re-recruited and invited for the intensive pharmacokinetic phase.
Samples collection: In the preliminary phase, mid-dose paired dried blood spots (DBS) (and dried breast milk spots in nursing mothers) samples will be collected at a single, recorded time point post dose. In the intensive pharmacokinetic phase, DBS (and dried breast milk spots in nursing mothers) samples will be collected at multiple time points after an observed dose of efavirenz or nevirapine. Samples will be shipped at room temperature to the Department of Molecular and Clinical Pharmacology, University of Liverpool, United Kingdom for analysis.
DNA extraction and SNP genotyping: Genomic DNA will be extracted using available commercial kits in accordance with the manufacture's protocol and genotyping will be performed by allelic discrimination real-time polymerase chain reaction using TaqMan® chemistry-based assays.
Drug quantification and pharmacokinetic analysis: Liquid chromatography-mass spectrometry methods will be developed for the quantification of efavirenz and nevirapine in DBS and dried breast milk spots. Pharmacokinetic parameters will be determined using standard procedures.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Pregnant women - efavirenz | – | Drug: EfavirenzPregnant women taking 600 mg efavirenz daily as part of combination antiretroviral therapy for PMTCT and for their own health |
| Nursing mothers - efavirenz | – | Drug: EfavirenzNursing mothers taking 600 mg efavirenz daily as part of combination antiretroviral therapy for PMTCT and for their own health and their breastfed babies |
| Pregnant women - nevirapine | – | Drug: NevirapinePregnant women taking 200 mg nevirapine twice daily as part of combination antiretroviral therapy for PMTCT and for their own health |
| Nursing mothers - nevirapine | – | Drug: NevirapineNursing mothers taking 200 mg nevirapine twice daily as part of combination antiretroviral therapy for PMTCT and for their own health and their breastfed babies |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- HIV positive pregnant women and nursing mothers taking efavirenz or nevirapine as part of HAART to prevent mother-to-child transmission of HIV and/or for their own health and their breastfed infants.
Key inclusion criteria (4 listed)
- HIV positive
- breastfeeding
- enrolled in PMTCT programme
- started efavirenz- or nevirapine-containing regimen during pregnancy
Key exclusion criteria (4 listed)
- exclusive replacement feeding
- mixed feeding before 6 months
- severe maternal or infant illness
- maternal or infant treatment with other drugs or herbal medication with known or uncertain interaction with study drug
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 |
|---|---|---|
| Efavirenz600 mg once daily in combination with other drugs (e.g. tenofovir and emtricitabine) | Drug | Nursing mothers - efavirenz, Pregnant women - efavirenz |
| Nevirapine200 mg twice daily in combination with other drugs (e.g. tenofovir and emtricitabine) | Drug | Nursing mothers - nevirapine, Pregnant women - nevirapine |
Primary outcome
Clearance over systemic availability (Cl/F) during pregnancy.
Time frame: Patients will be followed for an average of 6 months for the preliminary and intensive pharmacokinetic phase which will occur mainly between the second and third trimester of pregnancy.
Area under the concentration-time curve (AUC0-24 for efavirenz, AUC0-12 for nevirapine) during pregnancy.
Time frame: Patients will be followed for an average of 6 months for the preliminary and intensive pharmacokinetic phase which will occur mainly between the second and third trimester of pregnancy.
Minimum plasma drug concentration (Cmin) during pregnancy.
Time frame: Patients will be followed for an average of 6 months for the preliminary and intensive pharmacokinetic phase which will occur mainly between the second and third trimester of pregnancy.
Maximum plasma drug concentration (Cmax) during pregnancy.
Time frame: Patients will be followed for an average of 6 months for the preliminary and intensive pharmacokinetic phase which will occur mainly between the second and third trimester of pregnancy.
Plasma and breast milk clearance over systemic availability (Cl/F) during lactation.
Time frame: Pharmacokinetic visits in the preliminary or intensive pharmacokinetic phase will occur mainly from 1 week to 26 weeks postpartum.
Plasma and breast milk area under the concentration-time curve (AUC0-24 for efavirenz, AUC0-12 for nevirapine) during lactation.
Time frame: Pharmacokinetic visits in the preliminary or intensive pharmacokinetic phase will occur mainly from 1 week to 26 weeks postpartum.
Plasma and breast milk minimum drug concentration (Cmin) during lactation.
Time frame: Pharmacokinetic visits in the preliminary or intensive pharmacokinetic phase will occur mainly from 1 week to 26 weeks postpartum.
Plasma and breast milk maximum plasma drug concentration (Cmax) during lactation.
Time frame: Pharmacokinetic visits in the preliminary or intensive pharmacokinetic phase will occur mainly from 1 week to 26 weeks postpartum.
2 secondary outcomes
Rate of mother-to-child transmission of HIV.
Time frame: Infants will be followed up from birth until 18 months of age when all exposure to breastfeeding would have stopped.
Effect of pregnancy on CD4 count change (immunological recovery).
Time frame: CD4 counts will be determined every 6 months during pregnancy and postpartum, starting from recruitmnent.
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 6 Sep 2017.
- Results publication: PubMed 25326089Olagunju A, Bolaji OO, Amara A, Waitt C, Else L, Soyinka J, Adeagbo B, Adejuyigbe E, Siccardi M, Back D, Owen A, Khoo S. Development, validation and clinical application of a novel method for the quantification of efavirenz in dried breast milk spots using LC-MS/MS. J Antimicrob Chemother. 2015 Feb;70(2):555-61. doi: 10.1093/jac/dku420. Epub 2014 Oct 17.
- Results publication: PubMed 26108608Olagunju A, Amara A, Waitt C, Else L, Penchala SD, Bolaji O, Soyinka J, Siccardi M, Back D, Owen A, Khoo S. Validation and clinical application of a method to quantify nevirapine in dried blood spots and dried breast-milk spots. J Antimicrob Chemother. 2015 Oct;70(10):2816-22. doi: 10.1093/jac/dkv174. Epub 2015 Jun 24.
- Results publication: PubMed 25669165Olagunju A, Bolaji O, Amara A, Else L, Okafor O, Adejuyigbe E, Oyigboja J, Back D, Khoo S, Owen A. Pharmacogenetics of pregnancy-induced changes in efavirenz pharmacokinetics. Clin Pharmacol Ther. 2015 Mar;97(3):298-306. doi: 10.1002/cpt.43. Epub 2015 Jan 20.
- Results publication: PubMed 25882300Olagunju A, Bolaji O, Amara A, Waitt C, Else L, Adejuyigbe E, Siccardi M, Back D, Khoo S, Owen A. Breast milk pharmacokinetics of efavirenz and breastfed infants' exposure in genetically defined subgroups of mother-infant pairs: an observational study. Clin Infect Dis. 2015 Aug 1;61(3):453-63. doi: 10.1093/cid/civ317. Epub 2015 Apr 16.
- Results publication: PubMed 27195527Olagunju A, Bolaji O, Neary M, Back D, Khoo S, Owen A. Pregnancy affects nevirapine pharmacokinetics: evidence from a CYP2B6 genotype-guided observational study. Pharmacogenet Genomics. 2016 Aug;26(8):381-9. doi: 10.1097/FPC.0000000000000227.
- Results publication: PubMed 27268507Olagunju A, Khoo S, Owen A. Pharmacogenetics of nevirapine excretion into breast milk and infants' exposure through breast milk versus postexposure prophylaxis. Pharmacogenomics. 2016 Jun;17(8):891-906. doi: 10.2217/pgs-2015-0016. Epub 2016 Jun 7.
- Results publication: PubMed 28651173Waitt C, Diliiy Penchala S, Olagunju A, Amara A, Else L, Lamorde M, Khoo S. Development, validation and clinical application of a method for the simultaneous quantification of lamivudine, emtricitabine and tenofovir in dried blood and dried breast milk spots using LC-MS/MS. J Chromatogr B Analyt Technol Biomed Life Sci. 2017 Aug 15;1060:300-307. doi: 10.1016/j.jchromb.2017.06.012. Epub 2017 Jun 17.
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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.
Adeniyi Olagunju principal investigator
Obafemi Awolowo University, Nigeria
Andrew Owen, PhD principal investigator
University of Liverpool, United Kingdom
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of HIV and Pregnancy, run by Adeniyi Olagunju at 3 sites in Nigeria.
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 4 inclusion and 4 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 6 Sep 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Nigeria. 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.
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?
Clearance over systemic availability (Cl/F) during pregnancy. (time frame: Patients will be followed for an average of 6 months for the preliminary and intensive pharmacokinetic phase which will occur mainly between the second and third trimester of pregnancy.). The study lists 8 primary outcomes in all. 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 NCT02269462, which also lists 7 linked publications.
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 6 Sep 2017.