Human Immunodeficiency Virus InfectionVADICTNCT03284645
Viral and Antiretroviral Dynamics in HIV-1 Mother-to-Child Transmission Fluids
An observational study of Human Immunodeficiency Virus Infection, run by Obafemi Awolowo University at 4 sites in Nigeria.
Trial summary
More than 150,000 babies became infected with HIV in 2015 alone. When HIV drugs are started before or early in pregnancy, HIV positive women can give birth to HIV negative baby. This is possible because HIV drugs can reduce the amount of the virus in the body to the extent that they become undetectable by the time of… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Human Immunodeficiency Virus Infection
- What is being tested?
- Tenofovir Disoproxil Fumarate (TDF) 300 mg + Lamivudine (3TC) 300 mg + Efavirenz (EFV) 600 mg, Abacavir (ABC) 600 mg + Lamivudine (3TC) 300 mg + Efavirenz (EFV) 600 mg and Zidovudine (AZT) 300 mg + Lamivudine (3TC) 150 mg twice daily + Efavirenz (EFV) 600 mg once daily
- How many people
- 194 participants
- Where
- 4 sitesNigeria
- Study dates
- 22 Dec 2017to 17 Sep 2020
- 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: This is cohort study of HIV positive pregnant or recently postpartum women receiving WHO recommended first-line ART regimen. Pregnant women and nursing mothers initiating ART < 4 months before delivery (n = 60) and < 6 weeks postpartum (n = 60), respectively, and a comparison group of pregnant women who initiated ART ≥ 4 months before delivery (n = 120) will be recruited from four hospitals providing PMTCT services in Nigeria.
Who may be able to join
- ≥ 18 years old
- Planned exclusive breastfeeding until 6 months of age
- Able to understand study information and comply with follow-up schedule
Who cannot join
- Severe maternal or infant illness
- Planned exclusive formula feeding
- Taking medication with known or uncertain interaction with study drugs
Trial locations and contacts
4 sites in 1 country.
Nigeria4 sites
St. Monica's Hospital
Adikpo, Benue State
St. Thomas' Hospital
Ihugh, Benue State
Bishop Murray Medical Centre
Makurdi, Benue State
Federal Medical Centre
Makurdi, Benue State
About this study
Official title: Investigating Influence of Pregnancy-induced Changes in Antiretroviral Pharmacokinetics, Together With Polymorphisms in Drug Disposition Genes, on Viral Decay Dynamics in HIV Positive Women Starting Therapy Late in Pregnancy and Postpartum
More than 150,000 babies became infected with HIV in 2015 alone. When HIV drugs are started before or early in pregnancy, HIV positive women can give birth to HIV negative baby. This is possible because HIV drugs can reduce the amount of the virus in the body to the extent that they become undetectable by the time of delivery and during the breastfeeding period. However, some women do not start taking these drugs on time because they become infected during pregnancy or lactation. This leads to detectable virus at the time of delivery and puts the baby at risk of becoming infected. Also, the amounts of HIV drugs in the body have to be at certain levels for them to work effectively. But findings from some research have recently showed that pregnancy increases the rate at which the body removes some HIV drugs used to prevent the transfer of HIV from mother to child. While this may not cause any problem in women with no detectable virus before pregnancy, it may affect the rate at which the HIV virus is removed from the body in those starting treatment late and may put the baby at risk. This project will investigate whether the changes in drug exposure caused by pregnancy or other factors have any effect on the rate at which the HIV virus is removed from the body. HIV positive pregnant women and those who recently delivered will be recruited from different hospitals and follow up will be until breastfeeding ends. The investigators will not be involved in treatment decisions and the primary care provider will be responsible for prescribing antiretroviral regimen based on current guidelines. Samples will be collected to measure levels of the virus and the drugs in three fluids that transfer the virus to the baby: blood, genital fluid, and breastmilk. The HIV status of the babies will be monitored until they stop breastfeeding.
- Conditions
- Human Immunodeficiency Virus Infection
- Being tested
- Tenofovir Disoproxil Fumarate (TDF) 300 mg + Lamivudine (3TC) 300 mg + Efavirenz (EFV) 600 mg, Abacavir (ABC) 600 mg + Lamivudine (3TC) 300 mg + Efavirenz (EFV) 600 mg, Zidovudine (AZT) 300 mg + Lamivudine (3TC) 150 mg twice daily + Efavirenz (EFV) 600 mg once daily
- Medical subject headings
- Acquired Immunodeficiency Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tenofovir Disoproxil Fumarate (TDF) 300 mg + Lamivudine (3TC) 300 mg + Efavirenz (EFV) 600 mgDrug
Fixed-dose combination of 300 mg TDF, 300 mg 3TC and 600 mg EFV taken once daily.
Abacavir (ABC) 600 mg + Lamivudine (3TC) 300 mg + Efavirenz (EFV) 600 mgDrug
Fixed-dose combination of 600 mg ABC, 300 mg 3TC and 600 mg EFV taken once daily.
Zidovudine (AZT) 300 mg + Lamivudine (3TC) 150 mg twice daily + Efavirenz (EFV) 600 mg once dailyDrug
Fixed-dose combination of 300 mg AZT and 150 mg 3TC taken twice daily, plus 600 mg EFV taken once daily.
| Study group | Role | What they receive |
|---|---|---|
| ART Before or Early in Pregnancy | HIV positive pregnant women who started antiretroviral therapy (ART) before or early in pregnancy for prevention of mother-to-child transmission of HIV and for their own health. Receives: Drug: Tenofovir Disoproxil Fumarate (TDF) 300 mg + Lamivudine (3TC) 300 mg + Efavirenz (EFV) 600 mg; Drug: Abacavir (ABC) 600 mg + Lamivudine (3TC) 300 mg + Efavirenz (EFV) 600 mg; Drug: Zidovudine (AZT) 300 mg + Lamivudine (3TC) 150 mg twice daily + Efavirenz (EFV) 600 mg once daily | |
| ART Started Third Trimester | HIV positive pregnant women starting antiretroviral therapy (ART) during the third trimester of pregnancy for prevention of mother-to-child transmission of HIV and for their own health. Receives: Drug: Tenofovir Disoproxil Fumarate (TDF) 300 mg + Lamivudine (3TC) 300 mg + Efavirenz (EFV) 600 mg; Drug: Abacavir (ABC) 600 mg + Lamivudine (3TC) 300 mg + Efavirenz (EFV) 600 mg; Drug: Zidovudine (AZT) 300 mg + Lamivudine (3TC) 150 mg twice daily + Efavirenz (EFV) 600 mg once daily | |
| ART Started Postpartum | HIV positive women starting antiretroviral therapy (ART) after delivery for prevention of mother-to-child transmission of HIV and for their own health. Receives: Drug: Tenofovir Disoproxil Fumarate (TDF) 300 mg + Lamivudine (3TC) 300 mg + Efavirenz (EFV) 600 mg; Drug: Abacavir (ABC) 600 mg + Lamivudine (3TC) 300 mg + Efavirenz (EFV) 600 mg; Drug: Zidovudine (AZT) 300 mg + Lamivudine (3TC) 150 mg twice daily + Efavirenz (EFV) 600 mg once daily |
What is being measured
The primary outcome is the main question the study is designed to answer.
Polymorphisms in antiretrovirals disposition genes
Measured: At study enrolment
Minimum plasma drug concentration (Cmin)
Measured: At 2-3 months before delivery and at 10-12 weeks postpartum
Maximum plasma drug concentration (Cmax)
Measured: At 2-3 months before delivery and at 10-12 weeks postpartum
Area under the concentration-time curve (AUC)
Measured: At 2-3 months before delivery and at 10-12 weeks postpartum
Clearance over systemic availability (Cl/F)
Measured: At 2-3 months before delivery and at 10-12 weeks postpartum
HIV-1 viral load (RNA & DNA) in plasma
Measured: Through study completion (1-2 monthly)
HIV-1 viral load (RNA & DNA) in breastmilk
Measured: From 6 weeks postpartum through study completion (1-2 monthly)
HIV-1 viral load (RNA & DNA) in CVF
Measured: From week 28 to delivery (monthly)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2017
- Study start22 Dec 2017
- Primary completion31 Dec 2019
- Study completion17 Sep 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Human Immunodeficiency Virus InfectionStudies 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
- 194 participants (actual)
Sponsor and investigators
- Lead sponsor
- Obafemi Awolowo University
- Sponsor type
- University, hospital or other
- Collaborators
- Federal Medical Centre, Makurdi, University of Liverpool, University of California, San Diego, London School of Hygiene and Tropical Medicine
- Responsible party
- Sponsor
- Investigators
- Adeniyi Olagunju, PhD, Principal investigator, Obafemi Awolowo University, Nigeria
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03284645
- Sponsor's protocol ID
- NHREC/01/01/2007-05/06/2017
- Acronym
- VADICT
- Status last verified
- Oct 2020
- First submitted
- 2 Sep 2017
- Last updated
- 14 Oct 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Olagunju A, Anweh D, Okafor O et al. Viral and antiretroviral dynamics in HIV mother-to-child transmission fluids (VADICT) - Protocol and data analysis plan for a cohort study [version 1; referees: awaiting peer review]. Wellcome Open Res 2019, 4:34
Eniayewu O, Akinloye A, Shenkoya B, Azuka U, Bolaji O, Adejuyigbe E, Owen A, Olagunju A. Prenatal efavirenz exposure is independently associated with maternal, but not fetal CYP2B6 genotype. Pharmacogenet Genomics. 2024 Oct 1;34(8):253-260. doi: 10.1097/FPC.0000000000000542. Epub 2024 Jun 24.
PubMed 38934229Eniayewu O, Azuka U, Ogah J, Adejuyigbe E, Bolaji O, Olagunju A. Pharmacogenetics of Efavirenz Exposure in Cervicovaginal Fluid during Pregnancy and Postpartum. Clin Pharmacol Ther. 2024 Oct;116(4):1062-1070. doi: 10.1002/cpt.3343. Epub 2024 Jun 10.
PubMed 38859656
Study at a glance
From the registry record, last updated by the sponsor on 14 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigating Influence of Pregnancy-induced Changes in Antiretroviral Pharmacokinetics, Together With Polymorphisms in Drug Disposition Genes, on Viral Decay Dynamics in HIV Positive Women Starting Therapy Late in Pregnancy and Postpartum
- ClinicalTrials.gov ID
- NCT03284645
- Acronym / sponsor ID
- VADICT / NHREC/01/01/2007-05/06/2017
- Conditions
- Human Immunodeficiency Virus Infection
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 194 participants (actual)
- Lead sponsor
- Obafemi Awolowo UniversityUniversity, hospital or other
- Collaborators
- Federal Medical Centre, Makurdi, University of Liverpool, University of California, San Diego, London School of Hygiene and Tropical Medicine
- Study start
- 22 Dec 2017 (actual)
- Primary completion
- 31 Dec 2019 (actual)
- Study completion
- 17 Sep 2020 (actual)
- First posted
- 15 Sep 2017 (actual)
- 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.
More than 150,000 babies became infected with HIV in 2015 alone. When HIV drugs are started before or early in pregnancy, HIV positive women can give birth to HIV negative baby. This is possible because HIV drugs can reduce the amount of the virus in the body to the extent that they become undetectable by the time of delivery and during the breastfeeding period. However, some women do not start taking these drugs on time because they become infected during pregnancy or lactation. This leads to detectable virus at the time of delivery and puts the baby at risk of becoming infected. Also, the amounts of HIV drugs in the body have to be at certain levels for them to work effectively. But findings from some research have recently showed that pregnancy increases the rate at which the body removes some HIV drugs used to prevent the transfer of HIV from mother to child. While this may not cause any problem in women with no detectable virus before pregnancy, it may affect the rate at which the HIV virus is removed from the body in those starting treatment late and may put the baby at risk. This project will investigate whether the changes in drug exposure caused by pregnancy or other factors have any effect on the rate at which the HIV virus is removed from the body. HIV positive pregnant women and those who recently delivered will be recruited from different hospitals and follow up will be until breastfeeding ends. The investigators will not be involved in treatment decisions and the primary care provider will be responsible for prescribing antiretroviral regimen based on current guidelines. Samples will be collected to measure levels of the virus and the drugs in three fluids that transfer the virus to the baby: blood, genital fluid, and breastmilk. The HIV status of the babies will be monitored until they stop breastfeeding.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| ART Before or Early in Pregnancy | – | Drug: Tenofovir Disoproxil Fumarate (TDF) 300 mg + Lamivudine (3TC) 300 mg + Efavirenz (EFV) 600 mg, Drug: Abacavir (ABC) 600 mg + Lamivudine (3TC) 300 mg + Efavirenz (EFV) 600 mg, Drug: Zidovudine (AZT) 300 mg + Lamivudine (3TC) 150 mg twice daily + Efavirenz (EFV) 600 mg once dailyHIV positive pregnant women who started antiretroviral therapy (ART) before or early in pregnancy for prevention of mother-to-child transmission of HIV and for their own health. |
| ART Started Third Trimester | – | Drug: Tenofovir Disoproxil Fumarate (TDF) 300 mg + Lamivudine (3TC) 300 mg + Efavirenz (EFV) 600 mg, Drug: Abacavir (ABC) 600 mg + Lamivudine (3TC) 300 mg + Efavirenz (EFV) 600 mg, Drug: Zidovudine (AZT) 300 mg + Lamivudine (3TC) 150 mg twice daily + Efavirenz (EFV) 600 mg once dailyHIV positive pregnant women starting antiretroviral therapy (ART) during the third trimester of pregnancy for prevention of mother-to-child transmission of HIV and for their own health. |
| ART Started Postpartum | – | Drug: Tenofovir Disoproxil Fumarate (TDF) 300 mg + Lamivudine (3TC) 300 mg + Efavirenz (EFV) 600 mg, Drug: Abacavir (ABC) 600 mg + Lamivudine (3TC) 300 mg + Efavirenz (EFV) 600 mg, Drug: Zidovudine (AZT) 300 mg + Lamivudine (3TC) 150 mg twice daily + Efavirenz (EFV) 600 mg once dailyHIV positive women starting antiretroviral therapy (ART) after delivery for prevention of mother-to-child transmission of HIV and for their own health. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- This is cohort study of HIV positive pregnant or recently postpartum women receiving WHO recommended first-line ART regimen. Pregnant women and nursing mothers initiating ART < 4 months before delivery (n = 60) and < 6 weeks postpartum (n = 60), respectively, and a comparison group of pregnant women who initiated ART ≥ 4 months before delivery (n = 120) will be recruited from four hospitals providing PMTCT services in Nigeria.
Key inclusion criteria (3 listed)
- ≥ 18 years old
- Planned exclusive breastfeeding until 6 months of age
- Able to understand study information and comply with follow-up schedule
Key exclusion criteria (3 listed)
- Severe maternal or infant illness
- Planned exclusive formula feeding
- Taking medication with known or uncertain interaction with study drugs
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 |
|---|---|---|
| Tenofovir Disoproxil Fumarate (TDF) 300 mg + Lamivudine (3TC) 300 mg + Efavirenz (EFV) 600 mgFixed-dose combination of 300 mg TDF, 300 mg 3TC and 600 mg EFV taken once daily. | Drug | ART Before or Early in Pregnancy, ART Started Postpartum, ART Started Third Trimester |
| Abacavir (ABC) 600 mg + Lamivudine (3TC) 300 mg + Efavirenz (EFV) 600 mgFixed-dose combination of 600 mg ABC, 300 mg 3TC and 600 mg EFV taken once daily. | Drug | ART Before or Early in Pregnancy, ART Started Postpartum, ART Started Third Trimester |
| Zidovudine (AZT) 300 mg + Lamivudine (3TC) 150 mg twice daily + Efavirenz (EFV) 600 mg once dailyFixed-dose combination of 300 mg AZT and 150 mg 3TC taken twice daily, plus 600 mg EFV taken once daily. | Drug | ART Before or Early in Pregnancy, ART Started Postpartum, ART Started Third Trimester |
Primary outcome
Polymorphisms in antiretrovirals disposition genes
Time frame: At study enrolment
Minimum plasma drug concentration (Cmin)
Time frame: At 2-3 months before delivery and at 10-12 weeks postpartum
Maximum plasma drug concentration (Cmax)
Time frame: At 2-3 months before delivery and at 10-12 weeks postpartum
Area under the concentration-time curve (AUC)
Time frame: At 2-3 months before delivery and at 10-12 weeks postpartum
Clearance over systemic availability (Cl/F)
Time frame: At 2-3 months before delivery and at 10-12 weeks postpartum
HIV-1 viral load (RNA & DNA) in plasma
Time frame: Through study completion (1-2 monthly)
HIV-1 viral load (RNA & DNA) in breastmilk
Time frame: From 6 weeks postpartum through study completion (1-2 monthly)
HIV-1 viral load (RNA & DNA) in CVF
Time frame: From week 28 to delivery (monthly)
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 14 Oct 2020.
- BackgroundOlagunju A, Anweh D, Okafor O et al. Viral and antiretroviral dynamics in HIV mother-to-child transmission fluids (VADICT) - Protocol and data analysis plan for a cohort study [version 1; referees: awaiting peer review]. Wellcome Open Res 2019, 4:34
- Derived from this study: PubMed 38934229Eniayewu O, Akinloye A, Shenkoya B, Azuka U, Bolaji O, Adejuyigbe E, Owen A, Olagunju A. Prenatal efavirenz exposure is independently associated with maternal, but not fetal CYP2B6 genotype. Pharmacogenet Genomics. 2024 Oct 1;34(8):253-260. doi: 10.1097/FPC.0000000000000542. Epub 2024 Jun 24.
- Derived from this study: PubMed 38859656Eniayewu O, Azuka U, Ogah J, Adejuyigbe E, Bolaji O, Olagunju A. Pharmacogenetics of Efavirenz Exposure in Cervicovaginal Fluid during Pregnancy and Postpartum. Clin Pharmacol Ther. 2024 Oct;116(4):1062-1070. doi: 10.1002/cpt.3343. Epub 2024 Jun 10.
- Wellcome Open ResearchLink provided by the sponsor.
- Individual participant dataSharing planned: No
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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, PhD principal investigator
Obafemi Awolowo University, Nigeria
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Human Immunodeficiency Virus Infection, run by Obafemi Awolowo University at 4 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 3 inclusion and 3 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 14 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 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?
Polymorphisms in antiretrovirals disposition genes (time frame: At study enrolment). 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 NCT03284645, which also lists 3 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 14 Oct 2020.