An observational study in HIV Infections, sponsored by National Institute of Allergy and Infectious Diseases (NIAID). Completed at 11 sites in 4 countries. Per ClinicalTrials.gov, last updated 2022-09-23.
Sponsored by National Institute of Allergy and Infectious Diseases (NIAID) · Observational
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.
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 two groups of participants:
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.
4,258 studies on the registry are indexed under HIV Infections; 240 are open to participants now.
This study's enrollment of 1,765 is above the median of 200 across 713 observational studies indexed under HIV Infections.
Browse HIV Infections studies →National Institute of Allergy and Infectious Diseases (NIAID) is the lead sponsor of 2,401 studies on the registry; 179 are open to participants now.
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For antepartum (AP) exposure part of P1084s: Mother/infant pairs enrolled in the antepartum components of 1077BF or 1077FF (1077BA and 1077FA respectively) at African clinical sites approved as P1084s DXA sites.
For postpartum (PP) exposure part of P1084s: Mothers and their infants enrolled in the postpartum component of 1077BF (107BP) at African clinical sites approved as P1084s DXA sites.
Antepartum (AP) Part of Study (TDF Exposure During Pregnancy)
Inclusion Criteria:
Exclusion Criteria:
Postpartum (PP) Part of Substudy (TDF Exposure During Breastfeeding) (Note: this applies only to the new enrollment to P1084s, i.e., those who were not enrolled to P1084s while on the AP component)
Inclusion Criteria:
Exclusion Criteria:
* HIV-infected women exposed to TDF during pregnancy * Infants of HIV-infected women exposed to TDF during pregnancy
Drug: Tenofovir disoproxil fumarate (TDF)
* HIV-infected women exposed to TDF while breastfeeding * Infants of HIV-infected women exposed to TDF while breastfeeding
Drug: Tenofovir disoproxil fumarate (TDF)
* HIV-infected women not exposed to TDF during pregnancy * Infants of HIV-infected women not exposed to TDF during pregnancy
* HIV-infected women not exposed to TDF during breastfeeding * Infants of HIV-infected women not exposed to TDF during breastfeeding
Some participants will receive varying doses of TDF during pregnancy or breastfeeding as part of the larger study (IMPAACT 1077 PROMISE).
Antepartum Component: Creatinine clearance (CrCl)
Antepartum Component: Creatinine clearance (CrCl)
Time frame: For women and infants: at delivery/birth, up to Week 1
Antepartum Component: Bone resorption (Dpyr)
Antepartum Component: Bone resorption (Dpyr)
Time frame: For women and infants: at delivery/birth, up to Week 1
Antepartum Component: Lumbar spine bone mineral density (BMD) via dual energy e-ray absorptiometry (DXA)
Antepartum Component: Lumbar spine bone mineral density (BMD) via dual energy e-ray absorptiometry (DXA)
Time frame: For women: at delivery/birth, up to Week 1
Antepartum Component: Lumbar spine bone mineral content (BMC) and whole body BMC via DXA
Antepartum Component: Lumbar spine bone mineral content (BMC) and whole body BMC via DXA
Time frame: For infants: at delivery/birth, up to Week 1
Antepartum Component: Length-for-age Z-score
Antepartum Component: Length-for-age Z-score
Time frame: For infants: at delivery/birth, up to Week 1 and Week 26
Postpartum Component: CrCl
Postpartum Component: CrCl
Time frame: For women: at postpartum entry (delivery/birth, up to Week 1) and Week 74; for infants: at Week 26
Postpartum Component: Dpyr
Postpartum Component: Dpyr
Time frame: For women: at Week 74; for infants: at Week 26
Postpartum Component: Lumbar spine BMD via DXA
Postpartum Component: Lumbar spine BMD via DXA
Time frame: For women: at postpartum entry (delivery/birth, up to Week 1) and Week 74
Postpartum Component: Lumbar spine BMC via DXA
Postpartum Component: Lumbar spine BMC via DXA
Time frame: For infants: at Week 26
Postpartum Component: Length-for-age Z-score
Postpartum Component: Length-for-age Z-score
Time frame: For infants: at postpartum entry (delivery/birth, up to Week 1) and Week 26
CrCl
CrCl
Time frame: For women: Weeks 6, 26, and 74; for infants: at Weeks 10, 26, and 74
BMD
BMD
Time frame: For women: at delivery and change in hip BMD from delivery to Week 74
Dpyr
Dpyr
Time frame: For women: at Weeks 6, 26, and 74; for infants: at Weeks 10, 26, and 74
Mineral composition of breast milk
Mineral composition of breast milk
Time frame: For women: at Weeks 1, 6, 26, and 74
Lumbar spine BMC
Lumbar spine BMC
Time frame: For infants: Week 26
Infant growth
Infant growth
Time frame: For infants: at Weeks 10 and 74
Concentration of hormonal growth factors (for infants)
Concentration of hormonal growth factors (for infants)
Time frame: For infants: at birth and Weeks 10, 26, and 74
This study is completed, as verified in Sep 2022. You cannot join it, but the record below documents what was studied.
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National Institute of Allergy and Infectious Diseases (NIAID)