Sponsor study identifier
Secondary identifiers
OTHER_GRANT · U.S. Centers for Disease Control and Prevention
OTHER_GRANT · USAID
interventional
50
1 country
1
Study Start
December 12, 2018
Actual (reported)Primary Completion
August 20, 2019
Actual (reported)Study Completion
April 2020
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
The purpose of the study is to evaluate the safety, pharmacokinetics and pharmacodynamics of, and the tolerability and acceptance of an intravaginal ring (IVR) delivering both tenofovir and levonorgestrel (TFV/LNG) and an IVR delivering TFV only, compared to a placebo IVR, in women in Western Kenya.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
April 2020
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
November 16, 2018
Actual (reported)December 3, 2018
Actual (reported)December 12, 2018
Actual (reported)August 20, 2019
Actual (reported)April 2020
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Treatment-emergent adverse events (TEAEs)
Participants with Grade 2 or higher local female genital TEAEs as defined by DAIDS Table for Grading the Severity of Adult and Pediatric AEs (version 2.1) and DAIDS Table for Grading the Severity of Adult and Pediatric Adverse Events Addendum 1 Female Genital Grading Table for Use in Microbicide Studies
Change from Baseline to up to 90 days of IVR use
Safety Laboratory Assessments- Serum chemistry
Number of participants with abnormal serum chemistry
Change from Baseline to up to 90 days of IVR use
Safety Laboratory Assessments- lipids
Number of participants with abnormal lipids
Change from Baseline to up to 90 days of IVR use
Tenofovir/Levonorgestrel Intravaginal Ring
Tenofovir Intravaginal Ring
Placebo Intravaginal Ring
TFV/LNG IVR is an intravaginal ring that releases approximately 8-10 mg/day of TFV and approximately 20ug/day of LNG to be used for 90 continuous days.
TFV IVR is an intravaginal ring that releases approximately 8-10mg/day of TFV to be used for 90 continuous days.
Kenya Medical Research Institute, Center for Global Health Research
Kisumu, Kisumu County, 40100, Kenya
Thurman AR, Schwartz JL, Brache V, Clark MR, McCormick T, Chandra N, Marzinke MA, Stanczyk FZ, Dezzutti CS, Hillier SL, Herold BC, Fichorova R, Asin SN, Rollenhagen C, Weiner D, Kiser P, Doncel GF. Randomized, placebo controlled phase I trial of safety, pharmacokinetics, pharmacodynamics and acceptability of tenofovir and tenofovir plus levonorgestrel vaginal rings in women. PLoS One. 2018 Jun 28;13(6):e0199778. doi: 10.1371/journal.pone.0199778. eCollection 2018.
Mugo NR, Mudhune V, Heffron R, Thomas KK, McLellan-Lemal E, Njoroge B, Peacock S, O'Connor SM, Nyagol B, Ouma E, Ridzon R, Wiener J, Isoherranen N, Erikson DW, Ouattara LA, Yousefieh N, Jacot TA, Haaland RE, Morrison SA, Haugen HS, Thurman AR, Allen SA, Baeten JM, Samandari T, Doncel GF. Randomized controlled phase IIa clinical trial of safety, pharmacokinetics and pharmacodynamics of tenofovir and tenofovir plus levonorgestrel releasing intravaginal rings used by women in Kenya. Front Reprod Health. 2023 Jun 13;5:1118030. doi: 10.3389/frph.2023.1118030. eCollection 2023.
Nelly R. Mugo, MBChB
University of Washington
First Submitted
November 16, 2018
First Posted
December 3, 2018
Study Start
December 12, 2018
Actual (reported)Primary Completion
August 20, 2019
Actual (reported)A Study to Compare 3 Doses of a Hormonal Intra-uterine Device Containing Levonorgestrel and Indomethacin With a Hormonal Intra-uterine Device Containing Only Levonorgestrel to Assess the Effect and Safety of the Combined Components
Safety Laboratory Assessments- complete blood counts
Number of participants with abnormal complete blood counts
Change from Baseline to up to 90 days of IVR use
Mucosal safety
Changes in cervicovaginal mucosa by visual inspection
Change from Baseline to up to 90 days of IVR use
Maximum blood concentrations (Cmax)
Baseline; 6 and 24 hours post IVR insertion; Menstrual cycle 1, day 14; Menstrual cycle 1,day 21-25; Menstrual cycle 2, day 21-25; Menstrual cycle 3, day 14; Day 90 IVR use; 24 hours post-IVR use (anticipated cycle length is 28 days)
Maximum CV fluid concentration
6 and 24 hours post-IVR insertion; Menstrual cycle 1 day 14; Menstrual cycle 1 day 21-25; Menstrual cycle 2 day 21-25; Menstrual cycle 3, day 14; Day 90 of IVR use; and 24 hours post-IVR use (anticipated cycle length is 28 days)
Percent (%) inhibition of HIV resulting from product use (Anti-HIV activity)
Baseline, Day 90 of IVR use
Percent (%) inhibition of HSV resulting from product use (Anti-HSV activity)
Baseline, Day 90 of IVR use
Cervical mucus assessment and quality score
Menstrual cycle 1, day 14; Menstrual cycle 3, day 14 (anticipated cycle length is 28 days)
Qualitative assessment of acceptability and adherence influences through In-depth interviews
Between Menstrual cycle 2, day 21-25 and Menstrual cycle 3, day 14 (anticipated cycle length is 28 days)
Placebo IVR is an intravaginal ring containing no active experimental ingredients to be used for 90 continuous days.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
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McLellan-Lemal E, Deaton SR, Betts JE, Ondenge K, Mudhune V, O'Connor SM, Nyagol B, Thurman AR, Doncel GF, Allen SA, Heffron R, Mugo NR; Kisumu Combined Ring Study (KCRS) Team. Acceptability of an intravaginal ring for simultaneously preventing HIV infection and pregnancy: Qualitative findings of the Kisumu Combined Ring Study, 2019. Contemp Clin Trials. 2022 Nov;122:106935. doi: 10.1016/j.cct.2022.106935. Epub 2022 Sep 23.
Dabee S, Mugo N, Mudhune V, McLellan-Lemal E, Peacock S, O'Connor S, Njoroge B, Nyagol B, Thurman AR, Ouma E, Ridzon R, Wiener J, Haugen HS, Gasper M, Feng C, Allen SA, Doncel GF, Jaspan HB, Heffron R; Kisumu Combined Ring Study Team. Genital microbiota of women using a 90 day tenofovir or tenofovir and levonorgestrel intravaginal ring in a placebo controlled randomized safety trial in Kenya. Sci Rep. 2022 Jul 14;12(1):12040. doi: 10.1038/s41598-022-13475-9.
Study Completion
April 2020
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
January 14, 2020
Record last verified: 2020-01
Data sharing will comply with CDC's current Policy on Public Health Research and Non-research Data Management and Access. Except for the analyses outlined in the study protocol, all future requests to perform new analyses on data or specimens from this study protocol will require (1) agreement of all Parties owning or jointly owning the data and (2) Ethics Committee approval.
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Source: ClinicalTrials.gov.
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