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NCT04518228 · ClinicalTrials.gov registry record

Pharmacokinetic Properties of Antiretroviral and Anti-Tuberculosis Drugs During Pregnancy and Postpartum

A clinical trial of HIV Infections and Tuberculosis, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).

Completed
Registry status
205
Enrollment target
20
Study locations

NCT04518228 is a study of HIV Infections and Tuberculosis that has completed, run by National Institute of Allergy and Infectious Diseases (NIAID). The registered enrollment target is 205 participants, below the 445-participant average among 542 other HIV Infections trials with a reported enrollment target (54% lower). The trial reports 20 study locations across 10 states.

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The verdict

NCT04518228, a study of HIV Infections and Tuberculosis, has completed, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).

COMPLETED
Registry status
205 participants
Enrollment target
20
Study locations

Study Summary

The purpose of this study is to evaluate the pharmacokinetic (PK) properties of antiretroviral (ARV) and anti-tuberculosis (TB) drugs administered during pregnancy and postpartum.

Conditions Studied

HIV Infections Tuberculosis

Interventions

  • DRUG Bictegravir (BIC)
  • DRUG Tenofovir alafenamide (TAF)
  • DRUG Cabotegravir (CAB)
  • DRUG Dolutegravir (DTG)
  • DRUG Atazanavir/ritonavir (ATV/r)

Study Locations (20)

Other

  • Hospital Federal dos Servidores do Estado NICHD CRS - Rio de Janeiro
  • Hosp. Geral De Nova Igaucu Brazil NICHD CRS - Rio de Janeiro
  • Kenya Medical Research Institute / Walter Reed Project Clinical Research Center, Kericho CRS - Kericho
  • IMPAACT/ Gamma Project/ UPR Pediatric HIV/AIDS Research CRS - San Juan
  • Desmond Tutu TB Centre - Stellenbosch University (DTTC-SU) CRS - Cape Town

California

  • Usc La Nichd Crs - Los Angeles
  • David Geffen School of Medicine at UCLA NICHD CRS - Los Angeles
  • University of California, UC San Diego CRS- Mother-Child-Adolescent HIV Program - San Diego

Florida

  • South Florida CDTC Ft Lauderdale NICHD CRS - Fort Lauderdale
  • University of Florida Jacksonville NICHD CRS - Jacksonville
  • Pediatric Perinatal HIV NICHD CRS - Miami

Illinois

  • Rush University Cook County Hospital Chicago NICHD CRS - Chicago
  • Lurie Children's Hospital of Chicago (LCH) CRS (Site ID: 4001) - Chicago

New York

  • Bronx-Lebanon Hospital Center NICHD CRS - The Bronx
  • Jacobi Med. Ctr. Bronx NICHD CRS - The Bronx

Colorado

  • Univ. of Colorado Denver NICHD CRS - Aurora

Georgia

  • Emory University School of Medicine NICHD CRS - Atlanta

Maryland

  • Johns Hopkins Univ. Baltimore NICHD CRS - Baltimore

Trial Details

FieldValue
Enrollment Target 205 participants
Start Date 2021-09-01
Est. Completion 2025-07-10

Sponsor

National Institute of Allergy and Infectious Diseases (NIAID)

2,006 total trials

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What the Registry Record Tells You About NCT04518228

The ClinicalTrials.gov registry entry for NCT04518228 describes a study currently listed as completed, categorized as an unspecified phase. The registered enrollment target is 205 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 445-participant average among 542 other HIV Infections trials with a reported enrollment target (54% lower). The listed sponsor is National Institute of Allergy and Infectious Diseases (NIAID), which has 2,006 total studies on file at ClinicalTrials.gov.

The record links to 2 conditions, with HIV Infections appearing as the primary indexed condition, and to 5 interventions - of which Bictegravir (BIC) is the first listed.

NCT04518228 reports 20 study locations spanning 10 distinct geographic areas - top geographies include Other, California, Florida.

Frequently Asked Questions

What is clinical trial NCT04518228 about?

NCT04518228 is a clinical study titled "Pharmacokinetic Properties of Antiretroviral and Anti-Tuberculosis Drugs During Pregnancy and Postpartum". The purpose of this study is to evaluate the pharmacokinetic (PK) properties of antiretroviral (ARV) and anti-tuberculosis (TB) drugs administered during pregnancy and postpartum.

What is the current status of trial NCT04518228?

This trial is currently completed. The enrollment target is 205 participants. The study started on 2021-09-01. Estimated completion is 2025-07-10.

What conditions does trial NCT04518228 study?

This clinical trial studies the following conditions: HIV Infections, Tuberculosis.

What interventions are being tested in trial NCT04518228?

The interventions under investigation include: Bictegravir (BIC) (DRUG), Tenofovir alafenamide (TAF) (DRUG), Cabotegravir (CAB) (DRUG), Dolutegravir (DTG) (DRUG), Atazanavir/ritonavir (ATV/r) (DRUG).

Who is sponsoring clinical trial NCT04518228?

This trial is sponsored by National Institute of Allergy and Infectious Diseases (NIAID), which has 2,006 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT04518228 being conducted?

This trial has 20 study locations across California, Colorado, Florida, Georgia, Illinois. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.