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NCT Number: NCT03284645

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

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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Key information

Conditions

Human Immunodeficiency Virus Infection Acquired Immunodeficiency Syndrome Blood-Borne Infections Communicable Diseases Genital Diseases HIV Infections Immune System Diseases Immunologic Deficiency Syndromes Infections Lentivirus Infections RNA Virus Infections Retroviridae Infections Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Slow Virus Diseases Urogenital Diseases Virus Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

St. Monica's Hospital, Adikpo, Benue State, Nigeria

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

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

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

Drug

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

Primary outcomes

  1. Polymorphisms in antiretrovirals disposition genes

    Time frame: At study enrolment

  2. Minimum plasma drug concentration (Cmin)

    Time frame: At 2-3 months before delivery and at 10-12 weeks postpartum

  3. Maximum plasma drug concentration (Cmax)

    Time frame: At 2-3 months before delivery and at 10-12 weeks postpartum

  4. Area under the concentration-time curve (AUC)

    Time frame: At 2-3 months before delivery and at 10-12 weeks postpartum

  5. Clearance over systemic availability (Cl/F)

    Time frame: At 2-3 months before delivery and at 10-12 weeks postpartum

  6. HIV-1 viral load (RNA & DNA) in plasma

    Time frame: Through study completion (1-2 monthly)

  7. HIV-1 viral load (RNA & DNA) in breastmilk

    Time frame: From 6 weeks postpartum through study completion (1-2 monthly)

  8. HIV-1 viral load (RNA & DNA) in CVF

    Time frame: From week 28 to delivery (monthly)

Sponsors and collaborators

Lead sponsor

Obafemi Awolowo University

Other

Collaborators

  • Federal Medical Centre, Makurdi
  • London School of Hygiene and Tropical Medicine
  • University of California, San Diego
  • University of Liverpool

Registry information

Official study 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

Acronym: VADICT

Important dates

Study start
2017
Primary completion
2019
Study completion
2020
First posted
Sep 15, 2017
Registry last updated
Oct 14, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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