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Trial record 4 of 393 for:    LEVONORGESTREL

Darunavir and Rilpivirine Interactions With Levonorgestrel Implant (DRIVE-2)

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ClinicalTrials.gov Identifier: NCT03589027
Recruitment Status : Recruiting
First Posted : July 17, 2018
Last Update Posted : March 28, 2019
Sponsor:
Collaborators:
University of Nebraska
University of Pittsburgh
University of Liverpool
Information provided by (Responsible Party):
Infectious Diseases Institute, Makerere University

Brief Summary:
This study will evaluate the pharmacokinetic properties of Rilpivirine and Darunavir when used in combination with Levonorgestrel

Condition or disease Intervention/treatment Phase
HIV-1-infection Contraception Drug: Levonorgestrel two rod sub-dermal implant Drug: Rilpivirine Drug: Darunavir+Ritonavir Phase 2

Detailed Description:
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 (PK) study to describe levonorgestrel (LNG) 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 LNG 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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: A prospective, non-randomized, open-label, parallel, two-group, sparse-sampling pharmacokinetic (PK) study to describe levonorgestrel (LNG) PK parameters in two treatment groups (Rilpivirine or Darunavir- based ART) in 60 HIV-1 infected women.
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Pharmacokinetic Evaluation of Levonorgestrel Implant in HIV-Infected Women on Darunavir Versus Rilpivirine-based Antiretroviral Therapy
Actual Study Start Date : August 7, 2018
Estimated Primary Completion Date : June 2019
Estimated Study Completion Date : June 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

Arm Intervention/treatment
Experimental: Rilpivirine arm
All subjects will be administered oral rilpivirine 25mg once daily together with the rest of their oral antiretroviral combination plus a levonorgestrel two-rod subdermal implant (75mg/rod) through out the study period
Drug: Levonorgestrel two rod sub-dermal implant
Levonorgestrel (75 mg/rod), 2 rods (150 mg) inserted subdermally
Other Names:
  • Levonorgestrel
  • Jadelle

Drug: Rilpivirine
Oral ripilvirine 25mg once daily
Other Name: Edurant

Experimental: Darunavir arm
All subjects will be administered oral darunavir/ritonavir 600/100mg twice daily together with the rest of their oral antiretroviral combination plus a levonorgestrel two-rod subdermal implant (75mg/rod) through out the study period
Drug: Levonorgestrel two rod sub-dermal implant
Levonorgestrel (75 mg/rod), 2 rods (150 mg) inserted subdermally
Other Names:
  • Levonorgestrel
  • Jadelle

Drug: Darunavir+Ritonavir
Oral DRV/r 600/100mg twice daily
Other Name: DRV/r




Primary Outcome Measures :
  1. Levonorgestrel concentrations: Change in mean levonorgestrel (LNG) concentrations [ Time Frame: 6 months ]
    Comparison of the mean levonorgestrel (LNG) concentrations at month 6 between the rilpivirine (RPV) or darunavir (DRV) treatment groups versus historical controls


Secondary Outcome Measures :
  1. Change in mean rilpivirine concentration [ Time Frame: 12 months ]
    Rilpivirine mean concentration change prior to implant placement and then over the duration of the study time period.

  2. Change in mean darunavir concentration [ Time Frame: 12 months ]
    Darunavir mean concentration change prior to implant placement and then over the duration of the study time period.

  3. Adverse events [ Time Frame: 12 months ]
    Any signs and symptoms related to hormone exposure, including abnormal vaginal bleeding and local or systemic adverse events observed during the study period in both study groups.



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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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 LNG subdermal implant as a contraceptive method based on the WHO Medical Eligibility Criteria for Contraceptive Use11
  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 LNG, 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 14 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 LNG 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.

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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03589027


Contacts
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Contact: Senior Research Manager 0704817590 sokoboi@idi.co.ug

Locations
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Uganda
Infectious Diseases Institue Recruiting
Kampala, Uganda, 256
Contact: Stephen Research Manager    0392878652    sokoboi@idi.co.ug   
Principal Investigator: Mohammed Lamorde, PhD         
Sub-Investigator: Kimberley Scarsi, PharmD,MSc         
Sub-Investigator: Catherine Chappell, MD, MSc         
Sub-Investigator: Saye Khoo, PhD         
Sub-Investigator: Pauline Byakika, PhD         
Sub-Investigator: Kristin Darin, PharmD         
Sub-Investigator: Shadia Nakalema, MBChB, DTM&H         
Sub-Investigator: Stephen Walimbwa, MD         
Sub-Investigator: Julian Kaboggoza, BPharm         
Sponsors and Collaborators
Makerere University
University of Nebraska
University of Pittsburgh
University of Liverpool
Investigators
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Principal Investigator: Mohammed Lamorde, PhD Infectious Diseases Institute

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Responsible Party: Infectious Diseases Institute, Head of Department, Prevention Care and Treatment Infectious Diseases Institute, Makerere University College of Health Sciences, Makerere University
ClinicalTrials.gov Identifier: NCT03589027     History of Changes
Other Study ID Numbers: PK22
First Posted: July 17, 2018    Key Record Dates
Last Update Posted: March 28, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Levonorgestrel
Ritonavir
Darunavir
Rilpivirine
Anti-Retroviral Agents
HIV Protease Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-HIV Agents
Antiviral Agents
Anti-Infective Agents
Cytochrome P-450 CYP3A Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Contraceptive Agents, Female
Contraceptive Agents
Reproductive Control Agents
Physiological Effects of Drugs
Contraceptives, Oral, Synthetic
Contraceptives, Oral
Reverse Transcriptase Inhibitors
Nucleic Acid Synthesis Inhibitors