Darunavir and Rilpivirine Interactions With Etonogestrel Contraceptive Implant

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-09-25

Study Completion Date

2020-06-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

This study will evaluate the pharmacokinetic properties of rilpivirine and darunavir when used in combination with etonogestrel

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Darunavir and Rilpivirine Interactions With Levonorgestrel Implant

NCT03589027

HIV-1-infection Contraception

UNKNOWN PHASE2

Investigating the Interaction Between Two Long-acting Reversible Methods of Contraception and Dolutegravir, a Treatment for HIV

NCT04910711

Human Immunodeficiency Virus Contraception ART

UNKNOWN PHASE4

Atazanavir and Ritonavir (ATV/RTV) and an Oral Contraceptive in Healthy Females

NCT00357604

HIV Infections

COMPLETED PHASE1

Depot Contraception With and Without Lopinavir/Ritonavir

NCT01231451

HIV Infection

WITHDRAWN PHASE1

Pharmacokinetics, Pharmacodynamics and Cervicovaginal Lavage of Combined Oral Contraceptives and Raltegravir

NCT01597180

HIV

WITHDRAWN

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Despite the benefits of hormonal contraceptives, significant drug-drug interactions (DDIs) with some antiretroviral therapies (ART) represent a barrier to effective family planning methods for HIV-infected women. It is therefore critical to generate data on the combined use of hormonal contraceptives and ART. This study is a prospective, non-randomized, open-label, parallel, two-group, sparse-sampling pharmacokinetic study to describe etonogestrel (ENG) pharmacokinetic (PK) parameters in two treatment groups (rilpivirine or darunavir- based ART) in 60 HIV-1 infected women. The primary endpoint is the comparison of the mean ENG concentrations at month 6 between the rilpivirine or darunavir treatment groups versus historical controls. This study will provide information on effective ART options for HIV positive women who opt for the contraceptive implant as a family planning method of choice.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

HIV Contraception

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

A prospective, non-randomized, open-label, parallel, two-group, sparse-sampling pharmacokinetic study to describe etonogestrel (ENG) pharmacokinetic parameters in two treatment groups (rilpivirine or darunavir- based antiretroviral therapy) in 60 HIV-1 infected women. The primary endpoint is the comparison of the mean ENG concentrations at month 6 between the rilpivirine or darunavir treatment groups versus historical controls.

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Ripivirine arm

All subjects will be administered oral ripilvirine 25mg once daily together with the rest of their oral antiretroviral combination and an etonogestrel single-rod subdermal implant (68mg/rod). Study participants will have both interventions for a period of one year.

Group Type OTHER

Etonogestrel 68Mg Implant

Intervention Type DRUG

Etonogestrel single-rod subdermal implant (68mg/rod) will be administered to all study participants

rilpivirine

Intervention Type DRUG

Oral rilpvirine 25mg

Darunavir arm

All subjects will be administered oral DRV/r 600/100mg twice daily together with the rest of their oral antiretroviral combination and an etonogestrel single-rod subdermal implant (68mg/rod). Study participants will have both interventions for a period of one year.

Group Type OTHER

Etonogestrel 68Mg Implant

Intervention Type DRUG

Etonogestrel single-rod subdermal implant (68mg/rod) will be administered to all study participants

darunavir

Intervention Type DRUG

Oral darunavir+ritonavir 600/100mg

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Etonogestrel 68Mg Implant

Etonogestrel single-rod subdermal implant (68mg/rod) will be administered to all study participants

Intervention Type DRUG

rilpivirine

Oral rilpvirine 25mg

Intervention Type DRUG

darunavir

Oral darunavir+ritonavir 600/100mg

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Implanon Edurant DRV

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

1. Evidence of a personally signed and dated informed consent document indicating that the participant has been informed of all pertinent aspects of the study.
2. Participants who are willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures.
3. Women age 18 years to 45 years
4. Diagnosed with HIV infection
5. Medically eligible for the ENG subdermal implant as a contraceptive method based on the WHO Medical Eligibility Criteria for Contraceptive Use
6. Receiving EFV- or LPV/r-based ART for a minimum of 1 year
7. If not abstinent, must agree to use an effective non-hormonal method of contraception for the duration of the study including male and female condoms or the copper-T intrauterine device.
8. Participants must have a negative urine pregnancy test at entry and report no unprotected sex since the last menstrual period or in the last two weeks.

\-

Exclusion Criteria

1. HIV RNA greater than 50 copies/mL at the screening visit
2. CD4 count below 200 cells/mm3 at the screening visit
3. History of virologic failure on the current regimen (two consecutive viral load results equal to or greater than 400 copies/mL)
4. Serum hemoglobin less than 9.0 g/dl at screening
5. Elevations in serum levels of alanine transaminase (ALT) above 5 times the upper limit of normal
6. Elevations in serum creatinine above 2.5 times the upper limit of normal
7. Use of drugs known to be contraindicated with ENG, RPV (for women taking EFV-based ART), or DRV (for women taking LPV-based ART) within 30 days of study entry. Due to the dynamic nature of drug interactions related to antiretroviral therapy, the study team will review all concomitant medications at screening based on the US Department of Health and Human Services drug interaction table and the University of Liverpool HIV drug interaction tables (www.hiv-druginteractions.org)
8. Currently pregnant or postpartum \<30 days at study entry.
9. Breastfeeding women within 6 months of delivery.
10. Patients with a history of hypersensitivity to ENG implant, undiagnosed vaginal bleeding, diagnosed or suspected sex hormone dependent neoplasia, benign or malignant liver tumor, or thromboembolic disease.
11. Presence of any active clinically significant disease or life-threatening disease that, in the investigator's opinion, would compromise the subject's safety or outcome of the study.

\-

Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No