Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT03819114 · ClinicalTrials.gov registry record · Phase 2
Pharmacokinetic Study to Evaluate Double-Dose Levonorgestrel Emergency Contraception in Combination With Efavirenz-Based Antiretroviral Therapy or Rifampicin-Containing Anti-Tuberculosis Therapy
A Phase 2 study of HIV Infections and Tuberculosis, sponsored by Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections.
- Completed
- Registry status
- Phase 2
- Development phase
- 122
- Enrollment target
- 18
- Study locations
NCT03819114: Completed Phase 2 study of HIV Infections and Tuberculosis, sponsored by Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections.
NCT03819114 is a Phase 2 study of HIV Infections and Tuberculosis that has completed, run by Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections. The registered enrollment target is 122 participants, below the 446-participant average among 542 other HIV Infections trials with a reported enrollment target (73% lower). The trial reports 18 study locations across 9 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03819114, a Phase 2 study of HIV Infections and Tuberculosis, has completed, sponsored by Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 122 participants
- Enrollment target
- 18
- Study locations
Study Summary
The purpose of this pharmacokinetic (PK) study was to evaluate if a double dose (3 mg) of levonorgestrel (LNG) overcomes known drug-drug interactions (DDIs) with efavirenz (EFV)-based antiretroviral therapy (ART) or rifampicin (RIF)-containing tuberculosis (TB) therapy. The safety of double-dose (3.0 mg) LNG versus standard-dose (1.5 mg) was also compared.
Primary Outcome
AUC for each participant was calculated from all available LNG concentrations measured over 8 hours using the linear up/log down version of trapezoidal rule (i.e., noncompartmental technique) using the software package Phoenix WinNonLin (Certara®). This version of the trapezoidal rule used linear interpolation between untransformed data up to Cmax, and between log-transformed data from Cmax through Clast. Assay lower limit of quantification (LLOQ) for LNG was 0.025 ng/mL; values \< LLOQ were imp
Conditions Studied
Interventions
- DRUG Levonorgestrel (LNG)
Study Locations (18)
Other
- Gaborone CRS (12701) - Gaborone
- 12101 Instituto de Pesquisa Clinica Evandro Chagas (IPEC) CRS - Rio de Janeiro
- Kenya Medical Research Institute/Walter Reed Project Clinical Research Center (KEMRI/WRP) CRS (12501) - Kericho
- Blantyre CRS (30301) - Blantyre
- Malawi CRS (12001) - Lilongwe
- Durban Adult HIV CRS (11201) - Durban
- Soweto ACTG CRS (12301) - Johannesburg
- 31784 Chiang Mai University HIV Treatment CRS - Chiang Mai
Illinois
- 2701 Northwestern University CRS - Chicago
- Rush Univ. Med. Ctr. ACTG CRS (2702) - Chicago
Pennsylvania
- Hosp. of the Univ. of Pennsylvania CRS (6201) - Philadelphia
- Pitt CRS (1001) - Pittsburgh
New York
- Weill Cornell Upton CRS (7803) - New York
North Carolina
- Unc Aids Crs (3201) - Chapel Hill
Texas
- Trinity Health and Wellness Center CRS (31443) - Dallas
Gauteng
- University of the Witwatersrand Helen Joseph (WITS HJH) CRS (11101) - Johannesburg
West Cape
- Family Clinical Research Unit (FAM-CUR) CRS (8950) - Cape Town
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 122 participants |
| Start Date | 2019-05-06 |
| Est. Completion | 2020-11-30 |
| Phase | Phase 2 |
What the finished NCT03819114 record still lists
NCT03819114 is an interventional study that assigns participants to a tested intervention. The registered 122 participants enrollment target is mid-sized for trials with a published cap, below the 446-participant average among 542 other HIV Infections trials with a reported enrollment target (73% lower).
The record links to 2 conditions, with HIV Infections appearing as the primary indexed condition, and to 1 intervention - of which Levonorgestrel (LNG) is the first listed.
NCT03819114 lists 18 locations in 9 states (Other, Illinois, Pennsylvania).
Frequently Asked Questions
What is clinical trial NCT03819114 about?
NCT03819114 is a clinical study titled "Pharmacokinetic Study to Evaluate Double-Dose Levonorgestrel Emergency Contraception in Combination With Efavirenz-Based Antiretroviral Therapy or Rifampicin-Containing Anti-Tuberculosis Therapy". The purpose of this pharmacokinetic (PK) study was to evaluate if a double dose (3 mg) of levonorgestrel (LNG) overcomes known drug-drug interactions (DDIs) with efavirenz (EFV)-based antiretroviral therapy (ART) or rifampicin (RIF)-containing tuberculosis (TB) therapy. The safety of double-dose (3....
What is the current status of trial NCT03819114?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 122 participants. The study started on 2019-05-06. Estimated completion is 2020-11-30.
What conditions does trial NCT03819114 study?
This clinical trial studies the following conditions: HIV Infections, Tuberculosis.
What interventions are being tested in trial NCT03819114?
The interventions under investigation include: Levonorgestrel (LNG) (DRUG).
Who is sponsoring clinical trial NCT03819114?
This trial is sponsored by Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections, which has 45 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03819114 being conducted?
This trial has 18 study locations across Illinois, New York, North Carolina, Pennsylvania, Texas. 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 NCT03819114's enrollment target sits among peer trials
122 237th of 542 higher than 306 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
-
A Phase 2b Study Evaluating Oral VH4524184 Regimens in Treatment Naïve Persons With HIV-1 (INNOVATE Study)
RECRUITING · Phase 2
-
Microbiome Metabolites and Alcohol in HIV to Reduce CVD RCT
RECRUITING · Phase 2
-
Cholesterol and Inflammation Lowering Via Bempedoic Acid, an ACL-inhibiting Regimen in HIV Trial (CLEAR HIV Trial)
RECRUITING · Phase 2
-
Imaging Immune Activation in HIV by PET-MR
RECRUITING · Phase 2
-
A Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of a New Formulation of Cabotegravir Long-Acting Administered Intramuscularly in a 4-month Dosing Interval (Q4M)
ACTIVE NOT RECRUITING · Phase 2
-
A Study to Investigate the Virologic Efficacy and Safety of VH3810109 + Cabotegravir Compared to Standard of Care (SOC) in Male and Female Adults Living With Human Immunodeficiency Virus (HIV)
ACTIVE NOT RECRUITING · Phase 2
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
- NCT03363373 · 122 participants · Phase 2
Naxitamab for High-Risk Neuroblastoma Patients With Primary Refractory Disease or Incomplete Response to Salvage Treatment in Bone and/or Bone Marrow
- NCT03463954 · 122 participants · NA
Confirmatory Clinical Evaluation of Novilase® Laser Therapy for Focal Destruction of Malignant Breast Tumors
- NCT04503265 · 122 participants · Phase 1
A Trial of AMXI-5001 for Treatment in Patients With Advanced Malignancies
- NCT04700527 · 122 participants · Phase 1
The Effects of SCFA Supplementation in Subjects Receiving Abdominopelvic RT: A Randomized Controlled Study
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