A Prospective, Observational Study of Pregnancy Outcomes Among Women Exposed to Truvada for PrEP Indication
A Prospective, Observational Study of Pregnancy Outcomes Among Women Exposed to Truvada for PrEP Indication Nested in the Antiretroviral Pregnancy Registry
This is a prospective, observational study to describe pregnancy outcomes among HIV-1 uninfected pregnant women who are taking emtricitabine (FTC)/tenofovir disoproxil fumarate (TDF) (Truvada®) for a pre-exposure prophylaxis (PrEP) indication nested in the Antiretroviral Pregnancy Registry (APR).
Information on subjects is provided to the APR prospectively (prior to the outcome of the pregnancy being known) through their healthcare provider, with follow-up obtained from the healthcare provider following determination of the pregnancy outcome.
Studieoversigt
Status
Betingelser
Undersøgelsestype
Tilmelding (Faktiske)
Kontakter og lokationer
Studiesteder
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North Carolina
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Wilmington, North Carolina, Forenede Stater, 28405
- Antiretroviral Pregnancy Registry
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
- Barn
- Voksen
- Ældre voksen
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Prøveudtagningsmetode
Studiebefolkning
Number of Subjects and Subject Selection: 400 HIV-1 uninfected women who are exposed to FTC/TDF for PrEP during pregnancy stratified into 200 who decide to continue and 200 who choose to discontinue FTC/TDF for PrEP. A propensity score-matched comparison group of equal size (400 women) of HIV-positive pregnant women taking antiretrovirals.
All evaluable subjects enrolled into the APR who fulfill the inclusion criteria for the target cohort will be selected. Every year at the time of building the annual report for this study, a propensity score matched comparison group will be selected on a 1:1 ratio among all pregnant women on antiretrovirals.
Beskrivelse
Key Inclusion Criteria:
- Pregnant women
- Part of the prospective arm of the APR Target Group Inclusion Criteria
- HIV-1 Negative
- Choosing to remain on FTC/TDF for PrEP during pregnancy or,
- Choosing to discontinue FTC/TDF for PrEP during pregnancy Comparison Group Inclusion Criteria
- HIV-1 Positive
- On antiretroviral therapy
Key Exclusion Criteria:
- This is an observational nested study and will monitor all reported exposures without intervention/exclusion.
Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Kohorter og interventioner
Gruppe / kohorte |
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FTC/TDF for PrEP
The study has one target prospective cohort defined as HIV-1 negative women who had been prescribed FTC/TDF for pre-exposure prophylaxis (PrEP); with two strata: a) those who continue to take FTC/TDF for PrEP during their pregnancy, and b) those who decide to stop FTC/TDF for PrEP during pregnancy.
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ARV population
The study has one comparison cohort defined as HIV-positive women who were on any antiretroviral (ARV) medication at the time the pregnancy was detected.
This is a propensity score matched retrospective cohort selected from the prospective arm of the APR.
This cohort is assembled retrospectively in order to appropriately match the subjects by calendar time and the correlates of exposure, with exposure being defined as being on FTC/TDF for PrEP vs being exposed to other ARVs.
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
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Presence or absence of congenital malformations among infants born to HIV-1 uninfected women on FTC/TDF for PrEP
Tidsramme: Year 1
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Year 1
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Sekundære resultatmål
Resultatmål |
Tidsramme |
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Pregnancy outcomes in HIV-1 uninfected women who choose to continue or discontinue FTC/TDF for PrEP during their pregnancy as well as HIV-infected women treated with antiretrovirals
Tidsramme: Years 1, 2, and 3
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Years 1, 2, and 3
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Samarbejdspartnere og efterforskere
Sponsor
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- GS-US-276-0101
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