deltatrials
Completed PHASE1 INTERVENTIONAL 2-arm NCT00076791

Safety of Tenofovir Disoproxil Fumarate (TDF) and Emtricitabine/TDF in HIV Infected Pregnant Women and Their Infants

A Phase I Study of the Safety, Tolerance, and Pharmacokinetics of Tenofovir Disoproxil Fumarate (TDF) and the Combination of TDF Plus Emtricitabine 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
Updated 8 times since 2017 Last updated: Oct 28, 2021 Started: Mar 31, 2004 Primary completion: Mar 31, 2010 Completion: Mar 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 8 recorded versions since 2004 — 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 – ~Sep 2025 · 12 months · monthly snapshotCompleted~Sep 2025 – present · 12 months · monthly snapshotCompleted

Change History

8 versions recorded
  1. Sep 2025 — Present [monthly]

    Completed PHASE1

  2. Sep 2024 — Sep 2025 [monthly]

    Completed PHASE1

  3. Jul 2024 — Sep 2024 [monthly]

    Completed PHASE1

  4. Dec 2021 — Jul 2024 [monthly]

    Completed PHASE1

  5. Jan 2021 — Dec 2021 [monthly]

    Completed PHASE1

Show 3 earlier versions
  1. Jun 2018 — Jan 2021 [monthly]

    Completed PHASE1

  2. Feb 2017 — Jun 2018 [monthly]

    Completed PHASE1

  3. Jan 2017 — Feb 2017 [monthly]

    Completed PHASE1

    First recorded

Mar 2004

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)
  • International Maternal Pediatric Adolescent AIDS Clinical Trials Group
  • National Institute of Allergy and Infectious Diseases (NIAID)
Data source: National Institute of Allergy and Infectious Diseases (NIAID)

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