Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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: Completed study of HIV Infections and Tuberculosis, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
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. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
A target AUC was derived for each drug as the 10th percentile for the non-pregnant population based on historical control data. The target AUC is 58.7 mg\*h/L for Arm 1.1 and 10.0 mg\*h/L for Arm 1.2. Pharmacokinetic parameters were determined by the study pharmacologists from plasma concentration-time profiles using noncompartmental methods. McNemar's test was not conducted for Arm 1.2 due to low sample size.
Conditions Studied
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
| Field | Value |
|---|---|
| Enrollment Target | 205 participants |
| Start Date | 2021-09-01 |
| Est. Completion | 2025-07-10 |
What the finished NCT04518228 record still lists
NCT04518228 is an observational study that tracks outcomes without assigning an intervention. The registered 205 participants enrollment target is mid-sized for trials with a published cap, below the 445-participant average among 542 other HIV Infections trials with a reported enrollment target (54% lower).
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 names 20 study sites across 10 states, led by 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.
Learn More About Clinical Trials
Similar trials for HIV Infections
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT04518228's enrollment target sits among peer trials
205 168th of 542 higher than 374 of 542 other HIV Infections trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other HIV Infections trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
-
TRAC-ER Intervention to Reduce Risky Alcohol Use and HIV Risk
RECRUITING · NA
-
Community-based Education, Navigation, and Support Intervention for Military Veterans
RECRUITING · NA
-
CAR-T Cells for HIV Infection
RECRUITING · Phase 1
-
A Study to Investigate the Use of VH3810109 With or Without Fostemsavir (FTR) to Reduce the Size and Activity of the Viral Reservoir in People Living With HIV
RECRUITING · Phase 1
-
WiseApp for Spanish Speakers Living With HIV
RECRUITING · NA
-
Comprehensive HIV and Harm Prevention Via Telehealth
RECRUITING · NA
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT03457493 · 205 participants · Phase 1
The University of Alabama At Birmingham (UAB) Neuroinflammation in Parkinson's Disease-TSPO- Positron Emission Tomography (PET) Substudy
- NCT05134857 · 205 participants · Phase 2
The Zonisamide and Reinforcement for Reducing Alcohol Use (ZARRA) Study
- NCT05181891 · 205 participants · Phase 2
Pharmaceutically-Enhanced Reinforcement for Reduced Alcohol and Smoking
- NCT05283811 · 205 participants · NA
Understanding Prefrontal and Medial Temporal Neuronal Responses to Algorithmic Cognitive Variables in Epilepsy Patients
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI