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

This study is currently recruiting participants.
Verified March 2013 by National Institute of Allergy and Infectious Diseases (NIAID)
Sponsor:
Collaborators:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Gilead Sciences
Information provided by (Responsible Party):
National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier:
NCT01066858
First received: February 9, 2010
Last updated: March 18, 2013
Last verified: March 2013
History of Changes

February 9, 2010
March 18, 2013
March 2011
Not Provided
  • Antepartum Component: Creatinine clearance (CrCl) [ Time Frame: For women and infants: at delivery/birth, up to Week 1 ] [ Designated as safety issue: No ]
  • Antepartum Component: Bone resorption (Dpyr) [ Time Frame: For women and infants: at delivery/birth, up to Week 1 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • Antepartum Component: Length-for-age Z-score [ Time Frame: For infants: at delivery/birth, up to Week 1 and Week 26 ] [ Designated as safety issue: No ]
  • Postpartum Component: CrCl [ Time Frame: For women: at postpartum entry (delivery/birth, up to Week 1) and Week 74; for infants: at Week 26 ] [ Designated as safety issue: No ]
  • Postpartum Component: Dpyr [ Time Frame: For women: at Week 74; for infants: at Week 26 ] [ Designated as safety issue: No ]
  • Postpartum Component: Lumbar spine BMD via DXA [ Time Frame: For women: at postpartum entry (delivery/birth, up to Week 1) and Week 74 ] [ Designated as safety issue: No ]
  • Postpartum Component: Lumbar spine BMC via DXA [ Time Frame: For infants: at Week 26 ] [ Designated as safety issue: No ]
  • Postpartum Component: Length-for-age Z-score [ Time Frame: For infants: at postpartum entry (delivery/birth, up to Week 1) and Week 26 ] [ Designated as safety issue: No ]
  • Creatinine clearance (CrCl) [ Time Frame: For women: At antepartum randomization, delivery, and 26 weeks postpartum; For infants: At delivery and 26 weeks ] [ Designated as safety issue: No ]
  • Bone resorption (Dpyr) [ Time Frame: For Women: At delivery and 26 weeks postpartum; For infants: At delivery and 26 weeks ] [ Designated as safety issue: No ]
  • Total lumbar spine bone mineral density (LS BMD) via dual energy e-ray absorptiometry (DXA) [ Time Frame: For Women: At delivery and 26 weeks postpartum ] [ Designated as safety issue: Yes ]
  • Total lumbar spine bone mineral content (LS BMC) and whole body bone mineral content (WB BMC) [ Time Frame: For infants: at birth; LS BMC at 26 weeks ] [ Designated as safety issue: No ]
  • Infant growth as defined by length-for-age Z-score [ Time Frame: For infants: At birth and 26 weeks ] [ Designated as safety issue: No ]
  • LS BMC [ Time Frame: For infants (the breastfeeding exposure group): At 26 weeks ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01066858 on ClinicalTrials.gov Archive Site
  • CrCl [ Time Frame: For women: Weeks 6, 26, and 74; for infants: at Weeks 10, 26, and 74 ] [ Designated as safety issue: No ]
  • BMD [ Time Frame: For women: at delivery and change in hip BMD from delivery to Week 74 ] [ Designated as safety issue: No ]
  • Dpyr [ Time Frame: For women: at Weeks 6, 26, and 74; for infants: at Weeks 10, 26, and 74 ] [ Designated as safety issue: No ]
  • Mineral composition of breast milk [ Time Frame: For women: at Weeks 1, 6, 26, and 74 ] [ Designated as safety issue: No ]
  • Lumbar spine BMC [ Time Frame: For infants: Week 26 ] [ Designated as safety issue: No ]
  • Infant growth [ Time Frame: For infants: at Weeks 10 and 74 ] [ Designated as safety issue: No ]
  • Concentration of hormonal growth factors (for infants) [ Time Frame: For infants: at birth and Weeks 10, 26, and 74 ] [ Designated as safety issue: No ]
  • CrCl [ Time Frame: For women: at 6 weeks (mothers only) and 74 weeks; for infants: at 10 weeks and 74 weeks ] [ Designated as safety issue: No ]
  • Hip BMD [ Time Frame: For women: at delivery and change in hip BMD from delivery to 26 weeks and 74 weeks ] [ Designated as safety issue: Yes ]
  • LS BMD [ Time Frame: For women: at 74 weeks and change in LS BMD from delivery to 74 weeks for breastfeeding exposure group ] [ Designated as safety issue: Yes ]
  • Dpyr [ Time Frame: For women: at 6 weeks (mothers only) and 74 weeks; for infants: at 10 weeks and 74 weeks ] [ Designated as safety issue: No ]
  • Mineral composition of breast milk [ Time Frame: For women: at 1 week, 6 weeks, and 26 weeks ] [ Designated as safety issue: No ]
  • LS BMC [ Time Frame: For infants: 74 weeks ] [ Designated as safety issue: Yes ]
  • Infant growth [ Time Frame: For infants: at 10 weeks and 74 weeks ] [ Designated as safety issue: No ]
  • Concentration of hormonal growth factors (for infants) [ Time Frame: For infants: at birth, 10 weeks, 26 weeks, and 74 weeks ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Study of Effects of Tenofovir on Bone Health and Kidneys During Pregnancy and Breastfeeding
Maternal and Infant Monitoring for Evidence of Toxicity Related to Tenofovir Exposure: The Bone and Kidney Health Substudy of the IMPAACT 1077 PROMISE Protocol (Promoting Maternal and Infant Survival Everywhere)

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:

  • An antepartum exposure group to look at the effects of TDF during pregnancy
  • A postpartum exposure group to look at the effects of TDF during breastfeeding

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.
Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample

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.
HIV Infections
Drug: Tenofovir disoproxil fumarate (TDF)
Some participants will receive varying doses of TDF during pregnancy or breastfeeding as part of the larger study (IMPAACT 1077 PROMISE).
  • Maternal/infant antepartum exposure
    • HIV-infected women exposed to TDF during pregnancy
    • Infants of HIV-infected women exposed to TDF during pregnancy
    Intervention: Drug: Tenofovir disoproxil fumarate (TDF)
  • Maternal/infant postpartum exposure
    • HIV-infected women exposed to TDF while breastfeeding
    • Infants of HIV-infected women exposed to TDF while breastfeeding
    Intervention: Drug: Tenofovir disoproxil fumarate (TDF)
  • Maternal/infant antepartum no exposure
    • HIV-infected women not exposed to TDF during pregnancy
    • Infants of HIV-infected women not exposed to TDF during pregnancy
  • Maternal/infant postpartum no exposure
    • HIV-infected women not exposed to TDF during breastfeeding
    • Infants of HIV-infected women not exposed to TDF during breastfeeding

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
875
Not Provided
Not Provided

Antepartum (AP) Part of Study (TDF Exposure During Pregnancy)

Inclusion Criteria:

  • Mother-infant pair enrolled in 1077BA or 1077FA
  • At a clinical site that has been approved as a P1084s DXA site
  • 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

Exclusion Criteria:

  • None

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:

  • Mother and their infant enrolled in 1077BP
  • At a clinical site that has been approved as a P1084s DXA site
  • Enrolled in the substudy within 6 to 14 days of delivery, on the same day as enrollment in 1077BP
  • Willing and able to provide written informed consent to participate in this substudy

Exclusion Criteria:

  • TDF exposure during pregnancy [NOTE: TDF use for up to 12 days beginning at labor allowed]
  • Enrolled in the AP part of P1084s
Both
Not Provided
No
Not Provided
India,   Malawi,   South Africa,   Tanzania,   Uganda,   Zambia,   Zimbabwe
 
NCT01066858
P1084s (PROMISE), 10790, IMPAACT P1084s
Yes
National Institute of Allergy and Infectious Diseases (NIAID)
National Institute of Allergy and Infectious Diseases (NIAID)
  • Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
  • Gilead Sciences
Study Chair: George K. Siberry, MD, MPH NICHD/NIH
Study Chair: Lynda Stranix-Chibanda, MBChB, MMED University of Zimbabwe
National Institute of Allergy and Infectious Diseases (NIAID)
March 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP