A Pharmacokinetic Evaluation of Levonorgestrel Implant and Antiretroviral Therapy
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ClinicalTrials.gov Identifier: NCT01789879 |
Recruitment Status :
Completed
First Posted : February 12, 2013
Last Update Posted : April 4, 2016
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Condition or disease | Intervention/treatment | Phase |
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HIV Contraception | Drug: Levonorgestrel Drug: Nevirapine Drug: Efavirenz | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 60 participants |
Allocation: | Non-Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | A Pharmacokinetic Evaluation of Levonorgestrel Implant and Non-nucleoside Reverse Transcriptase Inhibitor (NNRTI)-Based Antiretroviral Therapy in HIV-infected Ugandan Women |
Study Start Date : | June 2013 |
Actual Primary Completion Date : | April 2014 |
Actual Study Completion Date : | October 2014 |
Arm | Intervention/treatment |
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Active Comparator: Control group (no current ART)
Levonorgestrel subdermal implant in subjects not yet receiving ART (control group)
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Drug: Levonorgestrel
Levonorgestrel 2-rod subdermal implant (75mg/rod) placed on study day 0 after baseline evaluations and remains in place until the subject requests removal or for the duration of drug activity (currently approved for 5 years).
Other Names:
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Active Comparator: NVP-based ART group
Levonorgestrel subdermal implant in subjects receiving nevirapine-based ART
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Drug: Levonorgestrel
Levonorgestrel 2-rod subdermal implant (75mg/rod) placed on study day 0 after baseline evaluations and remains in place until the subject requests removal or for the duration of drug activity (currently approved for 5 years).
Other Names:
Drug: Nevirapine Nevirapine 200mg twice daily as part of a complete antiretroviral therapy regimen. Subjects will be on this therapy prior to entry in this study.
Other Names:
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Active Comparator: EFV-based ART group
Levonorgestrel subdermal implant in subjects receiving efavirenz-based ART
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Drug: Levonorgestrel
Levonorgestrel 2-rod subdermal implant (75mg/rod) placed on study day 0 after baseline evaluations and remains in place until the subject requests removal or for the duration of drug activity (currently approved for 5 years).
Other Names:
Drug: Efavirenz Efavirenz 600mg once daily as part of a complete antiretroviral therapy regimen. Subjects will be on this therapy prior to entry in this study.
Other Names:
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- Levonorgestrel plasma concentrations [ Time Frame: 6 months after implant is placed ]
- NNRTI plasma concentrations [ Time Frame: Over 1 year (baseline, Months 1, 3, 6, 9, and 12) ]Applies to subjects being treated with either efavirenz- or nevirapine-based antiretroviral therapy
- Levonorgestrel plasma concentrations [ Time Frame: 1 year after implant is placed ]

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Evidence of a personally signed and dated informed consent document indicating that the subject (or a legal representative) has been informed of all pertinent aspects of the study.
- Subjects who are willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures.
- Women age 18 years or older
- Diagnosed with HIV-1 infection
- Desiring LNG subdermal implant as a contraceptive method
- Subjects not yet eligible for ART (based on the Ugandan Treatment Guidelines); or subjects receiving nevirapine or efavirenz-based ART for a minimum of 1 month prior to screening
Exclusion Criteria:
- For patients currently on ART: HIV-1 RNA > 400 copies/mL at screening visit
- Serum hemoglobin < 9.0 g/dl
- Elevations in serum levels of alanine transaminase (ALT) above 5 times the upper limit of normal
- Elevations in serum creatinine above 2.5 times the upper limit of normal
- Use of drugs known to be contraindicated with levonorgestrel, nevirapine (NVP group only), or efavirenz (EFV group only) 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 tables or the AIDS Clinical Trials Group Drug Interactions Database.
- Currently pregnant or postpartum <30 days at study entry
- No concurrent use of other hormonal contraception is allowed during the study period

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): NCT01789879
Uganda | |
Infectious Diseases Institute | |
Kampala, Uganda |
Principal Investigator: | Kimberly K Scarsi, PharmD, MSc | University of Nebraska |
Additional Information:
Publications of Results:
Responsible Party: | Kimberly Scarsi, PharmD, MS, BCPS-ID, Associate Professor, University of Nebraska |
ClinicalTrials.gov Identifier: | NCT01789879 History of Changes |
Other Study ID Numbers: |
LNG-NNRTI PK study 1R21HD074462-01 ( U.S. NIH Grant/Contract ) |
First Posted: | February 12, 2013 Key Record Dates |
Last Update Posted: | April 4, 2016 |
Last Verified: | March 2016 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Levonorgestrel Efavirenz Nevirapine Pharmacokinetics |
Anti-Retroviral Agents Efavirenz Nevirapine Levonorgestrel Antiviral Agents Anti-Infective Agents Reverse Transcriptase Inhibitors Nucleic Acid Synthesis Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Cytochrome P-450 CYP2C9 Inhibitors Cytochrome P-450 Enzyme Inhibitors |
Cytochrome P-450 CYP2C19 Inhibitors Cytochrome P-450 CYP2B6 Inducers Cytochrome P-450 Enzyme Inducers Cytochrome P-450 CYP3A Inducers Contraceptive Agents, Female Contraceptive Agents Reproductive Control Agents Physiological Effects of Drugs Contraceptives, Oral, Synthetic Contraceptives, Oral Anti-HIV Agents |