deltatrials
Completed NCT00042289

Pharmacokinetic Study of Antiretroviral Drugs and Related Drugs During and After Pregnancy

Pharmacokinetic Properties of Antiretroviral and Related Drugs During Pregnancy and Postpartum

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

Conditions HIV Infections
Interventions TAF w/cobicistat TAF w/cobicistat or ritonavir abacavir amikacin amprenavir atazanavir/cobicistat atazanavir/ritonavir dosage #1 atazanavir/ritonavir dosage #2 atazanavir/ritonavir/tenofovir dosage #1 bedaquiline capreomycin clofazamine darunavir/cobicistat darunavir/ritonavir dosage #1 darunavir/ritonavir dosage #2 darunavir/ritonavir dosage #3 darunavir/ritonavir dosage #4 delamanid didanosine delayed release (Videx® EC) dolutegravir efavirenz elvitegravir/cobicistat emtricitabine ethambutol ethinyl estradiol ethionamide/prothionamide etonogestrel implant etravirine fosamprenavir/ritonavir high dose INH indinavir/ritonavir dosage #1 indinavir/ritonavir dosage #2 isoniazid kanamycin levoflaxacin linezolid lopinavir/ritonavir dosage #1 lopinavir/ritonavir dosage #2 lopinavir/ritonavir dosage #3 lopinavir/ritonavir dosage #4 maraviroc moxifloxacin nelfinavir dosage #1 nelfinavir dosage #2 nevirapine ofloxacin para-aminosalicylic acid (PAS) pretomanid pyrazinamide raltegravir rifampicin rilpivirine tenofovir tenofovir alafenamide fumarate (TAF) tenofovir/atazanavir/ritonavir dosage #2 terizidone/cycloserine tipranavir/ritonavir
Updated 25 times since 2017 Last updated: Nov 18, 2025 Started: Jun 9, 2003 Primary completion: Sep 30, 2020 Completion: Sep 30, 2020

A observational or N/A phase clinical study on HIV Infections, this trial is completed. The trial is conducted by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) and has accumulated 25 data snapshots since 2003. Infectious disease trials contribute critical data for public health response and treatment development.

Status Flow

~Jan 2017 – ~Feb 2017 · 31 days · monthly snapshot~Feb 2017 – ~Jun 2017 · 4 months · monthly snapshot~Jun 2017 – ~Oct 2017 · 4 months · monthly snapshot~Oct 2017 – ~Nov 2017 · 31 days · monthly snapshot~Nov 2017 – ~Dec 2017 · 30 days · monthly snapshot~Dec 2017 – ~Jun 2018 · 6 months · monthly snapshot~Jun 2018 – ~Oct 2018 · 4 months · monthly snapshot~Oct 2018 – ~Nov 2018 · 31 days · monthly snapshot~Nov 2018 – ~Dec 2018 · 30 days · monthly snapshot~Dec 2018 – ~Jan 2019 · 31 days · monthly snapshot~Jan 2019 – ~Jun 2019 · 5 months · monthly snapshot~Jun 2019 – ~Aug 2019 · 2 months · monthly snapshot~Aug 2019 – ~Sep 2019 · 31 days · monthly snapshot~Sep 2019 – ~Nov 2019 · 2 months · monthly snapshot~Nov 2019 – ~Feb 2020 · 3 months · monthly snapshot~Feb 2020 – ~May 2020 · 3 months · monthly snapshot~May 2020 – ~Nov 2020 · 6 months · monthly snapshot~Nov 2020 – ~Jan 2021 · 2 months · monthly snapshot~Jan 2021 – ~Sep 2021 · 8 months · monthly snapshot~Sep 2021 – ~Sep 2022 · 12 months · monthly snapshot~Sep 2022 – ~Jul 2024 · 22 months · monthly snapshot~Jul 2024 – ~Sep 2024 · 2 months · monthly snapshot~Sep 2024 – ~Sep 2025 · 12 months · monthly snapshot~Sep 2025 – ~Jan 2026 · 4 months · monthly snapshot~Jan 2026 – present · 3 months · monthly snapshot

Change History

25 versions recorded

  1. Jan 2026 — Present [monthly]

    Completed

  2. Sep 2025 — Jan 2026 [monthly]

    Completed

  3. Sep 2024 — Sep 2025 [monthly]

    Completed

  4. Jul 2024 — Sep 2024 [monthly]

    Completed

  5. Sep 2022 — Jul 2024 [monthly]

    Completed

▶ Show 20 earlier versions

  1. Sep 2021 — Sep 2022 [monthly]

    Completed

    Phase: PHASE4 → None

  2. Jan 2021 — Sep 2021 [monthly]

    Completed PHASE4

  3. Nov 2020 — Jan 2021 [monthly]

    Completed PHASE4

    Status: Active Not Recruiting → Completed

  4. May 2020 — Nov 2020 [monthly]

    Active Not Recruiting PHASE4

  5. Feb 2020 — May 2020 [monthly]

    Active Not Recruiting PHASE4

    Status: Recruiting → Active Not Recruiting

  6. Nov 2019 — Feb 2020 [monthly]

    Recruiting PHASE4

  7. Sep 2019 — Nov 2019 [monthly]

    Recruiting PHASE4

  8. Aug 2019 — Sep 2019 [monthly]

    Recruiting PHASE4

  9. Jun 2019 — Aug 2019 [monthly]

    Recruiting PHASE4

  10. Jan 2019 — Jun 2019 [monthly]

    Recruiting PHASE4

  11. Dec 2018 — Jan 2019 [monthly]

    Recruiting PHASE4

  12. Nov 2018 — Dec 2018 [monthly]

    Recruiting PHASE4

  13. Oct 2018 — Nov 2018 [monthly]

    Recruiting PHASE4

  14. Jun 2018 — Oct 2018 [monthly]

    Recruiting PHASE4

  15. Dec 2017 — Jun 2018 [monthly]

    Recruiting PHASE4

  16. Nov 2017 — Dec 2017 [monthly]

    Recruiting PHASE4

  17. Oct 2017 — Nov 2017 [monthly]

    Recruiting PHASE4

  18. Jun 2017 — Oct 2017 [monthly]

    Recruiting PHASE4

  19. Feb 2017 — Jun 2017 [monthly]

    Recruiting PHASE4

  20. Jan 2017 — Feb 2017 [monthly]

    Recruiting PHASE4

    First recorded

Jun 2003

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)
Data source: National Institute of Allergy and Infectious Diseases (NIAID)

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

Study Locations

Atlanta, United States , Augusta, United States , Aurora, United States , Baltimore, United States , Bangkok, Thailand , Belo Horizonte, Brazil , Birmingham, United States , Boston, United States , Cape Town, South Africa , Chanthaburi, Thailand and 36 more locations