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

NCT04518228 · View on ClinicalTrials.gov ↗

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.

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

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT04518228

The ClinicalTrials.gov registry entry for NCT04518228 describes a study currently listed as completed. It is categorized as an unspecified phase, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 205 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is National Institute of Allergy and Infectious Diseases (NIAID), which has 1,295 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT04518228 reports 20 study locations spanning 10 distinct geographic areas — top geographies include Other, California, Florida. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

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). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT04518228?

This trial is sponsored by National Institute of Allergy and Infectious Diseases (NIAID), which has 1,295 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

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.

Related

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