NCT03819114 is a Phase 2 clinical trial of Levonorgestrel (LNG) in HIV Infections, sponsored by Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections.

What drugs are being tested in NCT03819114?

Interventions in NCT03819114: Levonorgestrel (LNG).

What condition does NCT03819114 study?

NCT03819114 studies HIV Infections, Tuberculosis.

Is NCT03819114 still recruiting?

NCT03819114 is currently completed. Last updated 27 December 2021.

Are results published for NCT03819114?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2021-12-27 · How we verify

NCT03819114

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

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

Completed Phase 2 Results posted Last updated 27 December 2021

What this trial tests

Phase 2 trial testing Levonorgestrel (LNG) in HIV Infections in 122 participants. Completed in 30 November 2020.

Timeline

6 May 2019

Primary endpoint
2 November 2020

30 November 2020

Quick facts

Lead sponsor	Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	122
Start date	6 May 2019
Primary completion	2 November 2020
Estimated completion	30 November 2020
Sites	18 locations across South Africa, Malawi, Botswana, Thailand, Kenya, United States, Brazil

Drugs / interventions tested

Levonorgestrel (LNG) — full drug profile →

Conditions studied

HIV Infections — all drugs for HIV Infections →
Tuberculosis — all drugs for Tuberculosis →

Sponsor

Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections

Who can join

16 and older, female only, with HIV Infections or Tuberculosis. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

LNG Area Under the Concentration-time Curve (AUC0-8h) Calculated Based on Intensive LNG PK Samples Obtained From Individual Participants Primary · Intensive LNG PK samples at pre-dose, and 0.5, 1, 1.5, 2, 3, 4, 6, and 8 hours post-dose

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 imputed as 0 (if pre-dose) or as 0.0125 (if post-dose).

Group	Value	95% CI
A: LNG 1.5 mg Among Participants on EFV-based ART (Randomized)	52.13	36.72 – 88.27
B: LNG 3.0 mg Among Participants on EFV-based ART (Randomized)	102.13	64.52 – 114.75
C: LNG 1.5 mg Among Participants on DTG-based ART (Assigned)	80.50	66.64 – 125.06
D: LNG 3.0 mg Among Participants on RIF-INH TB Therapy (Assigned)	124.39	87.10 – 168.79

Number and Percentage of Participants Experiencing Either a Serious Adverse Event (SAE) or Adverse Event (AE) Potentially or Definitely Associated With Single Dose LNG Administration. Secondary · From Day 0 through study Day 28

Adverse events were Graded according to the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), corrected Version 2.1, July 2017 and DAIDS AE Grading Table Addendum 1, Female Genital Grading Table for Use in Microbicide Studies, Version 1.0 - November 2007. Relationship of AE to study treatment was determined by the site, study core team, and DAIDS clinical representative. AEs evaluated in this outcome fulfilled the below criteria: * Potentially or definitely related to LNG dose * Grade 3 or higher AEs * Grade 2 of higher nausea, di

Group	Value	95% CI
LNG 1.5 mg	2
LNG 3.0 mg	2

Maximum Concentration (Cmax) of LNG Secondary · Intensive LNG PK samples at pre-dose, and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 24, and 48 hours post-dose

Cmax for each participant was calculated as the maximum observed LNG concentration from LNG PK samples at pre-dose through 48 hours post-dose. Standard noncompartmental techniques were used to determine Cmax using the software package Phoenix WinNonLin (Certara®).

Group	Value	95% CI
A: LNG 1.5 mg Among Participants on EFV-based ART (Randomized)	15.10	11.20 – 24.00
B: LNG 3.0 mg Among Participants on EFV-based ART (Randomized)	24.90	16.20 – 29.60
C: LNG 1.5 mg Among Participants on DTG-based ART (Assigned)	18.65	14.05 – 26.15
D: LNG 3.0 mg Among Participants on RIF-INH TB Therapy (Assigned)	28.01	23.00 – 39.60

Minimum Concentration (Cmin) of LNG Secondary · Intensive LNG PK samples at pre-dose, and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 24, and 48 hours post-dose

Cmin for each participant was calculated as the minimum observed LNG concentration from LNG PK samples at pre-dose through 48 hours post-dose. Standard noncompartmental techniques were used to determine Cmin using the software package Phoenix WinNonLin (Certara®). Assay lower limit of quantification for LNG was 0.025 ng/mL; values \< LLOQ were imputed as 0 (if pre-dose) or as 0.0125 (if post-dose).

Group	Value	95% CI
A: LNG 1.5 mg Among Participants on EFV-based ART (Randomized)	0.25	0.13 – 0.37
B: LNG 3.0 mg Among Participants on EFV-based ART (Randomized)	0.56	0.19 – 1.08
C: LNG 1.5 mg Among Participants on DTG-based ART (Assigned)	1.49	0.80 – 3.07
D: LNG 3.0 mg Among Participants on RIF-INH TB Therapy (Assigned)	0.41	0.17 – 0.74

Oral Clearance (CL/F) of LNG Secondary · Intensive LNG PK samples at pre-dose, and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 24, and 48 hours post-dose

Apparent oral clearance (CL/F) for each participant was calculated as CL/F = dose/AUC0-24 or CL/F = dose/AUC0-48 of the observed LNG concentration from LNG PK samples at pre-dose through 48 hours post-dose. Standard noncompartmental techniques were used to determine CL/F using the software package Phoenix WinNonLin (Certara®).

Group	Value	95% CI
A: LNG 1.5 mg Among Participants on EFV-based ART (Randomized)	12.64	10.44 – 21.06
B: LNG 3.0 mg Among Participants on EFV-based ART (Randomized)	15.24	12.59 – 27.66
C: LNG 1.5 mg Among Participants on DTG-based ART (Assigned)	4.39	2.89 – 6.59
D: LNG 3.0 mg Among Participants on RIF-INH TB Therapy (Assigned)	12.05	9.01 – 16.32

Volume of Distribution (Vd) of LNG Secondary · Intensive LNG PK samples at pre-dose, and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 24, and 48 hours post-dose

Vd for each participant was calculated from observed LNG concentration from LNG PK samples at pre-dose through 48 hours post-dose. Standard noncompartmental techniques were used to determine Vd using the software package Phoenix WinNonLin (Certara®).

Group	Value	95% CI
A: LNG 1.5 mg Among Participants on EFV-based ART (Randomized)	276.70	118.28 – 411.82
B: LNG 3.0 mg Among Participants on EFV-based ART (Randomized)	294.92	208.70 – 489.52
C: LNG 1.5 mg Among Participants on DTG-based ART (Assigned)	169.05	93.83 – 215.16
D: LNG 3.0 mg Among Participants on RIF-INH TB Therapy (Assigned)	156.31	105.26 – 247.20

Half-life (T1/2) of LNG Secondary · Intensive LNG PK samples at pre-dose, and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 24, and 48 hours post-dose

T1/2 for each participant was calculated using regression analysis when possible from the observed LNG concentration from LNG PK samples at pre-dose through 48 hours post-dose. Standard noncompartmental techniques were used to determine T1/2 using the software package Phoenix WinNonLin (Certara®).

Group	Value	95% CI
A: LNG 1.5 mg Among Participants on EFV-based ART (Randomized)	12.05	8.63 – 13.70
B: LNG 3.0 mg Among Participants on EFV-based ART (Randomized)	11.79	10.58 – 13.80
C: LNG 1.5 mg Among Participants on DTG-based ART (Assigned)	24.03	19.95 – 28.03
D: LNG 3.0 mg Among Participants on RIF-INH TB Therapy (Assigned)	8.97	6.72 – 11.89

Time of Minimum Concentration (Tmin) of LNG Secondary · Intensive LNG PK samples at pre-dose, and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 24, and 48 hours pose-dose

Tmin for each participant was time to the minimum observed LNG concentration after the observed dose.

Group	Value	95% CI
A: LNG 1.5 mg Among Participants on EFV-based ART (Randomized)	47.07	46.13 – 48.00
B: LNG 3.0 mg Among Participants on EFV-based ART (Randomized)	47.95	46.13 – 48.00
C: LNG 1.5 mg Among Participants on DTG-based ART (Assigned)	47.61	0.50 – 48.31
D: LNG 3.0 mg Among Participants on RIF-INH TB Therapy (Assigned)	48.00	46.55 – 48.00

LNG Area Under the Concentration Time Curve (AUC0-24h) Calculated Based on Intensive LNG PK Samples Obtained From Individual Participants Secondary · Intensive LNG PK samples at pre-dose, and 0.5, 1, 1.5, 2, 3, 4, 6, 8, and 24 hours post-dose

AUC for each participant was calculated from all available LNG concentrations measured over 24 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 for LNG was 0.025 ng/mL; values \< LLOQ were imputed as 0 (if pre-dose) or as 0.0125 (if post-dose).

Group	Value	95% CI
A: LNG 1.5 mg Among Participants on EFV-based ART (Randomized)	81.64	56.14 – 128.49
B: LNG 3.0 mg Among Participants on EFV-based ART (Randomized)	153.40	100.13 – 190.48
C: LNG 1.5 mg Among Participants on DTG-based ART (Assigned)	157.56	132.30 – 282.32
D: LNG 3.0 mg Among Participants on RIF-INH TB Therapy (Assigned)	213.69	148.64 – 283.22

LNG Area Under the Concentration Time Curve (AUC0-48h) Calculated Based on Intensive LNG PK Samples Obtained From Individual Participants Secondary · Intensive LNG PK samples at pre-dose, and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 24, and 48 hours pose-dose

AUC for each participant was calculated from all available LNG concentrations measured over 48 hours using the linear up/log down version of the 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 for LNG was 0.025 ng/mL; values \< LLOQ were imputed as 0 (if pre-dose) or as 0.0125 (if post-dose).

Group	Value	95% CI
A: LNG 1.5 mg Among Participants on EFV-based ART (Randomized)	98.95	66.38 – 141.27
B: LNG 3.0 mg Among Participants on EFV-based ART (Randomized)	180.25	106.87 – 216.75
C: LNG 1.5 mg Among Participants on DTG-based ART (Assigned)	224.81	178.30 – 400.90
D: LNG 3.0 mg Among Participants on RIF-INH TB Therapy (Assigned)	242.68	181.56 – 321.98

LNG Total Area Under the Concentration Time Curve AUCinf (Infinity) Calculated Based on Intensive LNG PK Samples Obtained From Individual Participants Secondary · Intensive LNG PK samples at pre-dose, and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 24, and 48 hours pose-dose

AUC for each participant was calculated from all available LNG concentrations measured to infinity 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 for LNG was 0.025 ng/mL; values \< LLOQ were imputed as 0 (if pre-dose) or as 0.0125 (if post-dose).

Group	Value	95% CI
A: LNG 1.5 mg Among Participants on EFV-based ART (Randomized)	118.71	71.23 – 143.69
B: LNG 3.0 mg Among Participants on EFV-based ART (Randomized)	196.83	108.48 – 238.24
C: LNG 1.5 mg Among Participants on DTG-based ART (Assigned)	345.80	227.80 – 518.69
D: LNG 3.0 mg Among Participants on RIF-INH TB Therapy (Assigned)	248.96	183.87 – 333.05

Adverse events — posted to ClinicalTrials.gov

Time frame: From study entry to study completion at Day 28 or premature study discontinuation.. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

A: LNG 1.5 mg Among Women on EFV-based ART (Randomized)

Serious: 0/17 (0%)

Deaths: 0/17

B: LNG 3.0 mg Among Women on EFV-based ART (Randomized)

Serious: 0/36 (0%)

Deaths: 0/36

C: LNG 1.5 mg Among Women on DTG-based ART (Assigned)

Serious: 0/35 (0%)

Deaths: 0/35

D: LNG 3.0 mg Among Women on RIF-INH TB Therapy (Assigned)

Serious: 1/34 (3%)

Deaths: 0/34

Serious adverse events (1 terms)

Reaction	System	A: LNG 1.5 mg Among Women …	B: LNG 3.0 mg Among Women …	C: LNG 1.5 mg Among Women …	D: LNG 3.0 mg Among Women …
Epilepsy	Nervous system disorders	—	—	—	—

Other adverse events (7 terms — click to expand)

Reaction	System	A: LNG 1.5 mg Among Women …	B: LNG 3.0 mg Among Women …	C: LNG 1.5 mg Among Women …	D: LNG 3.0 mg Among Women …
Nausea	Gastrointestinal disorders	—	—	—	—
Abdominal pain	Gastrointestinal disorders	—	—	—	—
Abdominal pain lower	Gastrointestinal disorders	—	—	—	—
Headache	Nervous system disorders	—	—	—	—
Heavy menstrual bleeding	Reproductive system and breast disorders	—	—	—	—
Intermenstrual bleeding	Reproductive system and breast disorders	—	—	—	—
Menstrual discomfort	Reproductive system and breast disorders	—	—	—	—

Most-reported serious reactions: Epilepsy.

Data from ClinicalTrials.gov NCT03819114 adverse events section.

Sponsor's own description

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.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

Pharmacokinetics of dose-adjusted levonorgestrel emergency contraception combined with efavirenz-based antiretroviral therapy or rifampicin-containing tuberculosis regimens.
Scarsi KK, Smeaton LM, Podany AT, Olefsky M, et al · · 2023 · cited 8× · PMID 36641094 · DOI 10.1016/j.contraception.2023.109951
Pharmacogenetic interactions of efavirenz or rifampin and isoniazid with levonorgestrel emergency contraception during treatment of HIV or tuberculosis.
Agyemang N, Scarsi KK, Baker P, Smeaton LM, et al · · 2023 · cited 3× · PMID 37306344 · DOI 10.1097/fpc.0000000000000501

Verify or expand the search:

Other recruiting trials for HIV Infections

Currently open trials in the same condition.

NCT07225530 — Implementation of Screen, Treat, and Triage for Women Living With HIV in La Romana (iSTAR) · NA · recruiting
NCT07202546 — A Phase 2b Study Evaluating Oral VH4524184 Regimens in Treatment Naïve Persons With HIV-1 (INNOVATE Study) · Phase 2 · recruiting
NCT06694753 — Safety and Immunogenicity Study of Three mRNAs Encoding HIV Immunogens in Adult Participants Without HIV and in Overall · Phase 1 · recruiting
NCT07235852 — Pilot Testing Into the Feasibility of the Developed Cognitive Behavioral Therapy Intervention · NA · recruiting
NCT06665646 — Clinical Trial to Evaluate the Safety and Immunogenicity of Hiltonol, Poly-ICLC-adjuvanted CD40.HIVRI.Env (VRIPRO) in Ad · Phase 1 · recruiting

Other Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections trials

Trials by the same sponsor.

NCT06205589 — Therapeutic ID93 + GLA-SE Vaccination in Participants With Rifampicin-Susceptible Pulmonary TB · Phase 2 · not yet recruiting
NCT06856174 — Menopausal HT for Women Living With HIV (HoT) · Phase 4 · not yet recruiting
NCT06205602 — Antiretrovirals Combined With Antibodies for HIV-1 Cure In Africa · Phase 2 · recruiting
NCT06031272 — Pausing Antiretroviral Treatment Under Structured Evaluation · Phase 1 · active not recruiting
NCT05985642 — Observational PIC Destination Cohort · recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT03819114 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 9 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections
Last refreshed: 27 December 2021

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03819114.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing