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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 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.
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.
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 |
Interested in This Trial?
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, categorized as Phase 2. The registered enrollment target is 122 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 446-participant average among 542 other HIV Infections trials with a reported enrollment target (73% lower). The listed sponsor is Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections, which has 45 total studies on file at ClinicalTrials.gov.
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 reports 18 study locations spanning 9 distinct geographic areas - top geographies include 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.
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