An observational study in Human Immunodeficiency Virus Infection, sponsored by Obafemi Awolowo University. Completed at 4 sites in Nigeria. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-10-14.
Sponsored by Obafemi Awolowo University · Observational
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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.
3,037 studies on the registry are indexed under Acquired Immunodeficiency Syndrome; 307 are open to participants now.
This study's enrollment of 194 is below the median of 289 across 504 observational studies indexed under Acquired Immunodeficiency Syndrome.
Browse Acquired Immunodeficiency Syndrome studies →Obafemi Awolowo University is the lead sponsor of 16 studies on the registry; none are open to participants now.
Compared within Acquired Immunodeficiency Syndrome, the registry's first condition term, which may not be this study's main condition. Counted across the registry records on this site, refreshed daily. How we classify →
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
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.
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
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.
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
HIV positive women starting antiretroviral therapy (ART) after delivery for prevention of mother-to-child transmission of HIV and for their own health.
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
Drug page: Tenofovir
Fixed-dose combination of 300 mg TDF, 300 mg 3TC and 600 mg EFV taken once daily.
Drug page: Abacavir
Fixed-dose combination of 600 mg ABC, 300 mg 3TC and 600 mg EFV taken once daily.
Drug page: Zidovudine
Fixed-dose combination of 300 mg AZT and 150 mg 3TC taken twice daily, plus 600 mg EFV taken once daily.
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)
Plan to share: No
Ran from Dec 2017 to primary completion in Dec 2019, 24 months.
Of 165 non-industry observational studies under Acquired Immunodeficiency Syndrome, half reached primary completion within 46 months of starting (the median), counting those still running; a quarter within 22 and three quarters within 83. This study's 24 months is below that.
Counting every sponsor, half of 177 studies reached it within 44 months; a quarter within 19 and three quarters within 79.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Oct 2020. You cannot join it, but the record below documents what was studied.
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Acquired Immunodeficiency Syndrome →
Obafemi Awolowo University