deltatrials
Completed PHASE1 INTERVENTIONAL 4-arm NCT00120471

Safety and Blood Levels of Tenofovir Disoproxil Fumarate in HIV Infected Pregnant Women and Their Babies

A Phase I Open Label Trial of the Safety and Pharmacokinetics of Tenofovir Disoproxil Fumarate in HIV-1 Infected Pregnant Women and Their Infants

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

Conditions HIV Infections
Interventions Tenofovir disoproxil fumarate
Updated 7 times since 2017 Last updated: Oct 28, 2021 Started: Nov 30, 2006 Primary completion: Oct 31, 2011 Completion: Dec 31, 2011
This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

This PHASE1 trial investigates HIV Infections and is currently completed. Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) leads this study, which shows 7 recorded versions since 2006 — indicating limited longitudinal coverage. Longitudinal tracking of infectious disease trials helps identify durability of treatment effects.

Status Flow

~Jan 2017 – ~Feb 2017 · 31 days · monthly snapshotCompleted~Feb 2017 – ~Jun 2018 · 16 months · monthly snapshotCompleted~Jun 2018 – ~Jan 2021 · 31 months · monthly snapshotCompleted~Jan 2021 – ~Dec 2021 · 11 months · monthly snapshotCompleted~Dec 2021 – ~Jul 2024 · 31 months · monthly snapshotCompleted~Jul 2024 – ~Sep 2024 · 2 months · monthly snapshotCompleted~Sep 2024 – present · 22 months · monthly snapshotCompleted

Change History

7 versions recorded

  1. Sep 2024 — Present [monthly]

    Completed PHASE1

  2. Jul 2024 — Sep 2024 [monthly]

    Completed PHASE1

  3. Dec 2021 — Jul 2024 [monthly]

    Completed PHASE1

  4. Jan 2021 — Dec 2021 [monthly]

    Completed PHASE1

  5. Jun 2018 — Jan 2021 [monthly]

    Completed PHASE1

▶ Show 2 earlier versions

  1. Feb 2017 — Jun 2018 [monthly]

    Completed PHASE1

  2. Jan 2017 — Feb 2017 [monthly]

    Completed PHASE1

    First recorded

Nov 2006

Trial started

Per CT.gov start date — pre-dates our first snapshot

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:
  • Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
  • National Institute of Allergy and Infectious Diseases (NIAID)
  • National Institute of Mental Health (NIMH)
  • National Institute on Drug Abuse (NIDA)
Data source: National Institute of Allergy and Infectious Diseases (NIAID)

For direct contact, visit the study record on ClinicalTrials.gov .

Study Locations