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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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12 December 2020 |
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Main ID: |
NCT03336346 |
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Date of registration:
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06/11/2017 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Effect of Dolutegravir on Etonogestrel Levels in HIV-infected Women in Botswana
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Scientific title:
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The Effect of Dolutegravir-based ART on Plasma Etonogestrel Levels in HIV-infected Women Using Contraceptive Implants in Botswana |
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Date of first enrolment:
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November 15, 2017 |
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Target sample size:
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148 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT03336346 |
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Study type:
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Observational |
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Study design:
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Phase:
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Countries of recruitment
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Botswana
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Contacts
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Name:
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Carolyn L Westhoff, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Columbia University |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Etonogestrel implant as their sole method of hormonal contraception
- Etonogestrel implant in-situ for three to twelve months.
- Dolutegravir (DTG) use for at least 60 days (Using DTG-based ART-regimen if
applicable)
- Efavirenz (EFV) use for at least 60 days (Using EFV-based ART-regimen if applicable)
Exclusion Criteria:
- Exclude women using concomitant enzyme-inducing drugs, including rifampicin for
tuberculosis treatment and anti-convulsant medications (phenytoin, carbamazepine,
barbiturates, primidone, topiramate, oxcarbazepine)
Age minimum:
18 Years
Age maximum:
45 Years
Gender:
Female
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Health Condition(s) or Problem(s) studied
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Contraceptive Usage
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Drug Interaction
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HIV Infections
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Intervention(s)
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Drug: Efavirenz
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Drug: dolutegravir
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Device: ENG implant
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Primary Outcome(s)
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Difference (percentage) in ENG plasma levels in the DTG group compared to no ART group
[Time Frame: Up to 12 months after implant]
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Secondary Outcome(s)
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Difference (percentage) in ENG plasma levels in the DTG group compared to EFV group
[Time Frame: Up to 12 months after implant]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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