Last updated on June 2019

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


Brief description of study

The purpose of this pharmacokinetic (PK) study is to evaluate if a double dose (3 mg) of levonorgestrel (LNG) emergency contraception (EC) 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 EC versus standard-dose (1.5 mg) will also be compared.

Detailed Study Description

This pharmacokinetic (PK) study will evaluate if a double dose (3.0 mg) of levonorgestrel (LNG) emergency contraception (EC) 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 EC versus standard-dose (1.5 mg) will also be compared.

Participants will be volunteers who do not currently require EC for contraception. This study will enroll women who are 16 years of age or older. Group assignment will be determined by infection status (HIV or TB; participants cannot be coinfected), and, for those who are living with HIV, by ART regimen at enrollment. Women living with HIV who are taking EFV-based ART will be randomized to receive a standard dose LNG EC (Group A) or a double dose of LNG EC (Group B). Women taking dolutegravir (DTG)-based ART will be assigned to a standard dose of LNG EC (Group C). Women who are HIV-negative and in the continuation phase of active TB treatment taking RIF and isoniazid (INH) will be assigned to a double dose of LNG EC (Group D).

At study entry, participants in Groups A and C will receive a standard single dose of LNG EC. Participants in Groups B and D will receive a double dose of LNG EC. Intensive PK monitoring will be conducted pre-dose, and after the LNG EC dose. Women are expected to be at the clinical site while the initial 8 hour PK samples are collected and may return for the 24 and 48 hour samples.

All participants will complete self-report questionnaires to assess adherence to TB therapy and ART, menstrual history and patterns after LNG EC administration, and to collect adverse effects commonly reported with LNG EC (i.e., irregular bleeding patterns). Adherence to ART and RIF will be assessed by collecting hair samples and single plasma concentrations at entry. All participants will be followed for 4 weeks.

Clinical Study Identifier: NCT03819114

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