MedTrace Logo

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

NCT03284645 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 194

Last updated 2020-10-14

No results posted yet for this study

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 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

Interventions

DRUG

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.

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.

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.

Sponsors & Collaborators

  • Federal Medical Centre, Makurdi

    collaborator UNKNOWN

  • University of Liverpool

    collaborator OTHER

  • University of California, San Diego

    collaborator OTHER

  • London School of Hygiene and Tropical Medicine

    collaborator OTHER

  • Obafemi Awolowo University

    lead OTHER

Principal Investigators

  • Adeniyi Olagunju, PhD · Obafemi Awolowo University, Nigeria

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-12-22
Primary Completion
2019-12-31
Completion
2020-09-17
FDA Drug
Yes

Countries

  • Nigeria

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03284645 on ClinicalTrials.gov