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Ensayos clínicos

Ensayos clínicos

Study of Effects of Tenofovir on Bone Health and Kidneys During Pregnancy and Breastfeeding

Patrocinador(es) del estudio: National Institute of Allergy and Infectious Diseases (NIAID)
Números de identificación: NCT01066858, P1084s (PROMISE)
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Propósito del estudio

The purpose of this study is to look at the effects of tenofovir disoproxil fumarate (an anti-HIV medication) on the bone health and kidneys of women with HIV during pregnancy and while breastfeeding. The study will also look at the changes in overall health, bone health and how the kidneys work in the infants of these women.

Afección:Fase:
Infecciones por el VIH
Fase 4

Detalles del estudio

A small number of adults (who are not pregnant) and children who take anti-HIV medications

develop problems with their kidneys and with the strength of their bones. These problems may

be more common when tenofovir disoproxil fumarate (TDF) is used. Studies about these bone

and kidney effects have not been done in pregnant and breastfeeding women and their infants.



This is a substudy of a larger study (IMPAACT 1077 PROMISE [Promoting Maternal and Infant

Survival Everywhere]) to evaluate the safety of anti-HIV medications used in pregnancy and

during breastfeeding. Only participants in the larger study randomly assigned to receive

maternal tenofovir disoproxil fumarate (TDF) or no maternal TDF during pregnancy or during

breastfeeding will be enrolled in this substudy.



This substudy will look at three groups of participants:



- An antepartum exposure group to look at the effects of TDF during pregnancy (about 450

women-infant pairs)



- A postpartum exposure group to look at the effects of TDF during breastfeeding (about

600 women-infant pairs)



- An antepartum and postpartum group to look at the effects of TDF during both pregnancy

and breastfeeding on mothers and their infants



All mother-infant pairs in the substudy will be followed for 74 weeks after delivery. During

this time, the women and their infants will have medical checkups and tests. The tests will

include tests of blood, urine, cord blood, and breast milk. Some of the women and infants

will have a special x-ray called a dual energy e-ray absorptiometry (DXA) scan to measure

bone strength. The timing of the tests—at enrollment, at delivery, at 6, 10, 26, or 74

weeks—will vary dependent on which part of this substudy women and infants are enrolled in.

Those in charge of the substudy will try to schedule medical visits and tests at the same

time as tests scheduled for the larger IMPAACT 1077 study.A small number of adults (who are not pregnant) and children who take anti-HIV medications

develop problems with their kidneys and with the strength of their bones. These problems may

be more common when tenofovir disoproxil fumarate (TDF) is used. Studies about these bone

and kidney effects have not been done in pregnant and breastfeeding women and their infants.



This is a substudy of a larger study (IMPAACT 1077 PROMISE [Promoting Maternal and Infant

Survival Everywhere]) to evaluate the safety of anti-HIV medications used in pregnancy and

during breastfeeding. Only participants in the larger study randomly assigned to receive

maternal tenofovir disoproxil fumarate (TDF) or no maternal TDF during pregnancy or during

breastfeeding will be enrolled in this substudy.



This substudy will look at three groups of participants:



- An antepartum exposure group to look at the effects of TDF during pregnancy (about 450

women-infant pairs)



- A postpartum exposure group to look at the effects of TDF during breastfeeding (about

600 women-infant pairs)



- An antepartum and postpartum group to look at the effects of TDF during both pregnancy

and breastfeeding on mothers and their infants



All mother-infant pairs in the substudy will be followed for 74 weeks after delivery. During

this time, the women and their infants will have medical checkups and tests. The tests will

include tests of blood, urine, cord blood, and breast milk. Some of the women and infants

will have a special x-ray called a dual energy e-ray absorptiometry (DXA) scan to measure

bone strength. The timing of the tests—at enrollment, at delivery, at 6, 10, 26, or 74

weeks—will vary dependent on which part of this substudy women and infants are enrolled in.

Those in charge of the substudy will try to schedule medical visits and tests at the same

time as tests scheduled for the larger IMPAACT 1077 study.

Criterios de inclusión

    AP part of study (TDF exposure during pregnancy) :
    • Mother-infant pair enrolled in 1077BA or 1077FA
    • Mother is Hepatitis B surface antigen positive
    • Enrolled in the substudy up to the Week 2 visit of 1077BA/1077FA (within 21 days
    after 1077BA/1077FA study entry) and prior to the start of labor
    • Willing and able to provide written informed consent to participate in this substudy

Criterios de exclusión

    :
    • None listed
    PP part of substudy (TDF exposure during breastfeeding) Inclusion Criteria
    • Mother and their infant enrolled in 1077BP
    • Participating at an African clinical site with access to a DXA scanner
    • Enrolled in the substudy within 12 days of delivery, on same day as enrollment in
    1077BP
    • Willing and able to provide written informed consent to participate in this substudy

Centros de estudio/contactos

Malawi

    College of Med. JHU CRS, Blantyre, Malawi

    University of North Carolina Lilongwe CRS, Lilongwe, Malawi

Gauteng

    Soweto IMPAACT CRS, Johannesburg, Gauteng, South Africa

    Shandukani Research CRS, Johannesburg, Gauteng, 2001, South Africa

KwaZulu-Natal

    Durban Paediatric HIV CRS, Durban, KwaZulu-Natal, 4001, South Africa

    CAPRISA Umlazi CRS, Umlazi, KwaZulu-Natal, 4066, South Africa

    Stellenbosch Univ. CRS, Cape Town, KwaZulu-Natal, 7505, South Africa

Mpigi

    MU-JHU Research Collaboration CRS, Kampala, Mpigi, 7505, Uganda

    St Mary's CRS, Chitungwiza, Mpigi, 7505, Zimbabwe

    Seke North CRS, Chitungwiza, Mpigi, 7505, Zimbabwe

    UZ-Parirenyatwa CRS, Harare, Mpigi, 7505, Zimbabwe

Actualizado: 26 de abril del 2013

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