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Viral and Antiretroviral Dynamics in HIV-1 Mother-to-Child Transmission Fluids

NCT ID: NCT03284645

Last Updated: 2020-10-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

194 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-12-22

Study Completion Date

2020-09-17

Brief Summary

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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.

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Detailed Description

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Conditions

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Human Immunodeficiency Virus Infection

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

Tenofovir Disoproxil Fumarate (TDF) 300 mg + Lamivudine (3TC) 300 mg + Efavirenz (EFV) 600 mg

Intervention Type DRUG

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 mg

Intervention Type DRUG

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 daily

Intervention Type DRUG

Fixed-dose combination of 300 mg AZT and 150 mg 3TC taken twice daily, plus 600 mg EFV taken 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.

Tenofovir Disoproxil Fumarate (TDF) 300 mg + Lamivudine (3TC) 300 mg + Efavirenz (EFV) 600 mg

Intervention Type DRUG

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 mg

Intervention Type DRUG

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 daily

Intervention Type DRUG

Fixed-dose combination of 300 mg AZT and 150 mg 3TC taken twice daily, plus 600 mg EFV taken 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.

Tenofovir Disoproxil Fumarate (TDF) 300 mg + Lamivudine (3TC) 300 mg + Efavirenz (EFV) 600 mg

Intervention Type DRUG

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 mg

Intervention Type DRUG

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 daily

Intervention Type DRUG

Fixed-dose combination of 300 mg AZT and 150 mg 3TC taken twice daily, plus 600 mg EFV taken once daily.

Interventions

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Tenofovir Disoproxil Fumarate (TDF) 300 mg + Lamivudine (3TC) 300 mg + Efavirenz (EFV) 600 mg

Fixed-dose combination of 300 mg TDF, 300 mg 3TC and 600 mg EFV taken once daily.

Intervention Type DRUG

Abacavir (ABC) 600 mg + Lamivudine (3TC) 300 mg + Efavirenz (EFV) 600 mg

Fixed-dose combination of 600 mg ABC, 300 mg 3TC and 600 mg EFV taken once daily.

Intervention Type DRUG

Zidovudine (AZT) 300 mg + Lamivudine (3TC) 150 mg twice daily + Efavirenz (EFV) 600 mg once daily

Fixed-dose combination of 300 mg AZT and 150 mg 3TC taken twice daily, plus 600 mg EFV taken once daily.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* ≥ 18 years old
* Planned exclusive breastfeeding until 6 months of age
* Able to understand study information and comply with follow-up schedule

Exclusion Criteria

* Severe maternal or infant illness
* Planned exclusive formula feeding
* Taking medication with known or uncertain interaction with study drugs
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Federal Medical Centre, Makurdi

UNKNOWN

Sponsor Role collaborator

University of Liverpool

OTHER

Sponsor Role collaborator

University of California, San Diego

OTHER

Sponsor Role collaborator

London School of Hygiene and Tropical Medicine

OTHER

Sponsor Role collaborator

Obafemi Awolowo University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Adeniyi Olagunju, PhD

Role: PRINCIPAL_INVESTIGATOR

Obafemi Awolowo University, Nigeria

Locations

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St. Monica's Hospital

Adikpo, Benue State, Nigeria

Site Status

St. Thomas' Hospital

Ihugh, Benue State, Nigeria

Site Status

Bishop Murray Medical Centre

Makurdi, Benue State, Nigeria

Site Status

Federal Medical Centre

Makurdi, Benue State, Nigeria

Site Status

Countries

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Nigeria

References

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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

Reference Type BACKGROUND

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.

Reference Type DERIVED
PMID: 38934229 (View on PubMed)

Related Links

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https://wellcomeopenresearch.org/articles/4-34/v1

Wellcome Open Research

Other Identifiers

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NHREC/01/01/2007-05/06/2017

Identifier Type: -

Identifier Source: org_study_id

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