MedTrace Logo

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

NCT01066858 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 1765

Last updated 2022-09-23

No results posted yet for this study

Summary

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.

Conditions

  • HIV Infections

Interventions

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).

Sponsors & Collaborators

  • Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

    collaborator NIH

  • Gilead Sciences

    collaborator INDUSTRY

  • National Institute of Allergy and Infectious Diseases (NIAID)

    lead NIH

Principal Investigators

  • George K. Siberry, MD, MPH · NICHD/NIH

  • Lynda Stranix-Chibanda, MBChB, MMED · University of Zimbabwe

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-03-22
Primary Completion
2015-11-30
Completion
2015-11-30

Countries

  • Malawi
  • South Africa
  • Uganda
  • Zimbabwe

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01066858 on ClinicalTrials.gov