Clinical Trials Logo

Clinical Trial Summary

This study evaluates whether there is an interaction between etonogestrel, the progestin hormone released by the contraceptive implant Nexplanon, and efavirenz, a common medication used to treat HIV. The endpoints measured in this study will help determine if such an interaction leads to decreased contraceptive efficacy of the contraceptive implant.


Clinical Trial Description

Women now make up nearly half of the world's HIV-infected population, and many of these women with HIV are of reproductive age. There is a growing need to provide effective contraception for those women who want or need to be protected against pregnancy. However, there is concern for decreased contraceptive efficacy in women on antiretroviral therapy who rely on hormonal contraception due to drug-drug interactions. Of particular concern is a possible interaction with etonogestrel, the active hormone in a long-acting reversible contraceptive implant. We propose a pilot study to evaluate the effect of efavirenz (EFV), a commonly used non-nucleoside reverse transcriptase inhibitor, on the pharmacokinetics of the etonogestrel implant. We will recruit 18 healthy women who have had the implant in place for 12 to 24 months. They will be asked to take a two-week course of efavirenz. During these two weeks and for four additional weeks, we will monitor semi-weekly etonogestrel concentrations, and serum, ultrasound, and cervical mucus markers of ovulation. We will also assess efavirenz concentration at baseline and at the end of the two-week treatment course. We will derive pharmacokinetic parameters and compare concentrations across time points. Results will help to inform the design of larger studies, and of similar studies with different antiretroviral medications. We hypothesize that taking efavirenz while using the etonogestrel contraceptive implant will not result in an increased incidence of ovulation. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT01980342
Study type Interventional
Source Johns Hopkins University
Contact
Status Terminated
Phase Phase 4
Start date October 2014
Completion date April 4, 2018

See also
  Status Clinical Trial Phase
Completed NCT04645940 - Fruquintinib Food Effect and Proton Pump Inhibitor Study Phase 1
Completed NCT04540965 - Impact of a Histamine H2 Receptor Antagonist (H2RA) on the Pharmacokinetics (PK) of Telaglenastat in Healthy Subjects Phase 1
Completed NCT04531072 - Effect of Atazanavir-ritonavir on the Pharmacokinetics and Toxicity of Lumefantrine Phase 4
Completed NCT03385525 - Study to Evaluate the Effect of UGT Inhibition by Valproic Acid on the Pharmacokinetics of BIIB074 Phase 1
Completed NCT05680792 - Pharmacokinetic Interaction Between Nitazoxanide and Atazanavir/Ritonavir in Healthy Volunteers N/A
Completed NCT05137548 - A Drug-Drug Interaction Study Between ATI-2173 and Tenofovir Disoproxil Fumarate in Healthy Subjects Phase 1
Not yet recruiting NCT05525351 - The Application and Validation of Triple Drug Response Surface Models on Density Spectral Array in Clinical Anesthesia
Completed NCT04080596 - DDI Study to Investigate the Impact of Itraconazole on the Pharmacokinetics of Dorzagliatin Phase 1
Recruiting NCT04593680 - Assessment of Drug-drug Interactions Between Masculinizing Hormone Therapy and Antiretroviral Agents Concomitantly for Pre-exposure Prophylaxis Among Transgender Men N/A
Active, not recruiting NCT04590417 - Assessment of Drug-drug Interactions Between Feminizing Hormone Therapy and Emtricitabine/Tenofovir Alafenamide Concomitantly for Pre-exposure Prophylaxis Among Transgender Women N/A
Completed NCT05633147 - Effect of Clarithromycin on PK of Linaprazan, Linaprazan on PK of Clarithromycin and Linaprazan on PK of Midazolam Phase 1
Completed NCT02391688 - Evaluation of the Potential Pharmacokinetic Interactions Between Probe Drugs in the Geneva Phenotyping Cocktail Phase 1
Completed NCT00806299 - Loperamide Grapefruit Juice Interaction PK Trial Phase 1
Completed NCT03336346 - Effect of Dolutegravir on Etonogestrel Levels in HIV-infected Women in Botswana
Completed NCT04818086 - Drug-drug Interaction Study of Lemborexant as an Adjunctive Treatment for Buprenorphine/Naloxone for Opioid Use Disorder Phase 1/Phase 2
Completed NCT03187015 - A Study to Examine the Effects of Entinostat on Midazolam in Healthy Adult Subjects Phase 1
Not yet recruiting NCT04463576 - Drug Interactions in Hospital Information System. The PRoSIT System..
Not yet recruiting NCT03920566 - The Effect of ENZAlutamide on the Anti-Xa Levels of Patients Receiving DOACs
Completed NCT03011996 - To Investigate PK and PD of CJ-12420, Clarithromycin, Amoxicillin After Multiple Dose Administration Phase 1
Completed NCT04902105 - Drug-Drug Interaction Study to Evaluate the Effect of Inhibition of UGTs on the PK of Ecopipam and Its Active Metabolite Phase 1