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

PHASE2CompletedINTERVENTIONAL
Enrollment

122

Participants

Timeline

Start Date

May 6, 2019

Primary Completion Date

November 2, 2020

Study Completion Date

November 30, 2020

Conditions
HIV InfectionsTuberculosis
Interventions
DRUG

Levonorgestrel (LNG)

LNG tablet(s) were administered by mouth in a directly observed manner.

Trial Locations (18)

2193

University of the Witwatersrand Helen Joseph (WITS HJH) CRS (11101), Johannesburg

7505

Family Clinical Research Unit (FAM-CUR) CRS (8950), Cape Town

10065

Weill Cornell Upton CRS (7803), New York

10330

31802 Thai Red Cross AIDS Research Centre (TRC-ARC) CRS, Bangkok

15213

Pitt CRS (1001), Pittsburgh

19104

Hosp. of the Univ. of Pennsylvania CRS (6201), Philadelphia

20200

Kenya Medical Research Institute/Walter Reed Project Clinical Research Center (KEMRI/WRP) CRS (12501), Kericho

21040

12101 Instituto de Pesquisa Clinica Evandro Chagas (IPEC) CRS, Rio de Janeiro

27514

Unc Aids Crs (3201), Chapel Hill

50200

31784 Chiang Mai University HIV Treatment CRS, Chiang Mai

60611

2701 Northwestern University CRS, Chicago

60612

Rush Univ. Med. Ctr. ACTG CRS (2702), Chicago

75208

Trinity Health and Wellness Center CRS (31443), Dallas

Unknown

Gaborone CRS (12701), Gaborone

Blantyre CRS (30301), Blantyre

Malawi CRS (12001), Lilongwe

Soweto ACTG CRS (12301), Johannesburg

4013 SF

Durban Adult HIV CRS (11201), Durban

All Listed Sponsors
collaborator

National Institute of Allergy and Infectious Diseases (NIAID)

NIH

lead

Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections

NETWORK

NCT03819114 - Pharmacokinetic Study to Evaluate Double-Dose Levonorgestrel Emergency Contraception in Combination With Efavirenz-Based Antiretroviral Therapy or Rifampicin-Containing Anti-Tuberculosis Therapy | Biotech Hunter | Biotech Hunter