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COMPLETED Phase 2

Pharmacokinetic Study to Evaluate Double-Dose Levonorgestrel Emergency Contraception in Combination With Efavirenz-Based Antiretroviral Therapy or Rifampicin-Containing Anti-Tuberculosis Therapy

NCT03819114 · View on ClinicalTrials.gov ↗

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.

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

FieldValue
Enrollment Target 122 participants
Start Date 2019-05-06
Est. Completion 2020-11-30
Phase Phase 2

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT03819114

The ClinicalTrials.gov registry entry for NCT03819114 describes a study currently listed as completed. It is categorized as Phase 2, 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 122 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections, which has 15 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 1 intervention — of which Levonorgestrel (LNG) 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: NCT03819114 reports 18 study locations spanning 9 distinct geographic areas — top geographies include Other, Illinois, Pennsylvania. 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 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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT03819114?

The interventions under investigation include: Levonorgestrel (LNG) (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT03819114?

This trial is sponsored by Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections, which has 15 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

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.

Related

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