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Trial record 4 of 407 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

Tracking Information
First Submitted Date  ICMJE May 29, 2018
First Posted Date  ICMJE July 17, 2018
Last Update Posted Date March 28, 2019
Actual Study Start Date  ICMJE August 7, 2018
Estimated Primary Completion Date June 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 16, 2018)
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
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03589027 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: July 16, 2018)
  • 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.
  • 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.
  • 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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Darunavir and Rilpivirine Interactions With Levonorgestrel Implant
Official Title  ICMJE A Pharmacokinetic Evaluation of Levonorgestrel Implant in HIV-Infected Women on Darunavir Versus Rilpivirine-based Antiretroviral Therapy
Brief Summary This study will evaluate the pharmacokinetic properties of Rilpivirine and Darunavir when used in combination with Levonorgestrel
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE 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
Condition  ICMJE
  • HIV-1-infection
  • Contraception
Intervention  ICMJE
  • 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
  • Drug: Darunavir+Ritonavir
    Oral DRV/r 600/100mg twice daily
    Other Name: DRV/r
Study Arms  ICMJE
  • 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
    Interventions:
    • Drug: Levonorgestrel two rod sub-dermal implant
    • Drug: Rilpivirine
  • 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
    Interventions:
    • Drug: Levonorgestrel two rod sub-dermal implant
    • Drug: Darunavir+Ritonavir
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: July 16, 2018)
60
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE June 2020
Estimated Primary Completion Date June 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.

    -

Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years to 45 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Senior Research Manager 0704817590 sokoboi@idi.co.ug
Listed Location Countries  ICMJE Uganda
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03589027
Other Study ID Numbers  ICMJE PK22
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Infectious Diseases Institute, Makerere University
Study Sponsor  ICMJE Makerere University
Collaborators  ICMJE
  • University of Nebraska
  • University of Pittsburgh
  • University of Liverpool
Investigators  ICMJE
Principal Investigator: Mohammed Lamorde, PhD Infectious Diseases Institute
PRS Account Makerere University
Verification Date March 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP