A Phase 1 interventional study of Tenofovir 1% gel and Vaginal product in HIV Prevention, sponsored by CONRAD. Completed at 2 sites in United States. Open to female participants aged 18 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2015-05-22.
Sponsored by CONRAD · Phase 1 and Interventional
The purpose of the study is determine if the local release characteristics and systemic exposure to tenofovir (TFV) 1% gel and a given commonly used vaginal product are impacted by concomitant use
This study consists of three separate crossover studies, each evaluating if local release characteristics and systemic exposure to TFV 1% gel and a given vaginal product are impacted by concomitant use. Vaginal products to be assessed are: antifungal cream, antimicrobial gel, and the combination contraceptive vaginal ring (IVR). There will be no comparison between vaginal product groups.
Participants will be randomized to vaginal product. Participants in the cream and gel cohorts will be randomized to the order of treatment conditions (TFV gel alone, vaginal product alone, and TFV gel and vaginal product concomitantly). Participants in the IVR cohort will use TFV gel alone during the first crossover period; the order of the remaining treatment conditions (IVR alone, TFV and IVR concomitantly) for crossover periods 2 and 3 will be randomly assigned.
Each participant will attend a total of at least 7 visits. At the first visit, volunteers will be consented and will undergo procedures to assess whether they are eligible to continue in the study. If eligible, they will undergo 3 crossover treatment periods. Within each crossover treatment period there will be 2 visits, which will be scheduled to occur within the same menstrual cycle; the first visit will be in the follicular phase of the menstrual cycle such that product use is initiated on cycle day 9 to 18 and the second visit will be on cycle day 16 to 24.
At the start of crossover period 1, after it has been confirmed that the participant meets all of the inclusion criteria and none of the exclusion criteria, she will be randomized to a vaginal product cohort and to a sequence of the treatment conditions for the 3 crossover periods. Crossover periods 2 and 3 will be scheduled in the subsequent menstrual cycles, with the first visit of each crossover period occurring approximately 2 weeks after the completion of the previous crossover period.
Product usage during the 3 crossover periods is as follows:
Each participant will be contacted by phone approximately 1-2 weeks after completion of crossover period 3 to confirm that there have been no additional adverse experiences. If necessary, she may be seen in an unscheduled visit for follow-up. She will then be exited from the study.
CONRAD is the lead sponsor of 38 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
History of sensitivity/allergy to any component of:
Participants will vaginally insert 1 applicator of TFV gel twice a day for 7 days, with each dose inserted approximately 12 hours after the previous dose (for a total of 13 doses). Each applicator contains 4.4 gm of TFV 1% gel.
Drug: Tenofovir 1% gel
Participants will use their assigned vaginal product for 5 to 21 days depending on the dosing instructions for the particular product: 1. Terconazole 0.4% vaginal cream: once a day for seven days. 1 applicator (5 gm) of terconazole cream contains 20 mg terconazole. 2. Metronidazole gel: once a day for 5 days. 1 applicator (5 gm)of metronidazole gel contains 37.5 mg metronidazole. 3. Contraceptive IVR: insert ring and leave in place for 21 days; return to clinic for removal on day 21. The IVR contains two active components, etonogestrel (progestin) and ethinyl estradiol (estrogen).
Drug: Vaginal product
Tenofovir gel: Participants will vaginally insert 1 applicator of TFV gel twice a day for 7 days, with each dose inserted approximately 12 hours after the previous dose (for a total of 13 doses). Each applicator contains 4.4 gm of TFV 1% gel. In addition, Participants will use their assigned vaginal product for 5 to 21 days depending on the dosing instructions for the particular product: 1. Terconazole 0.4% vaginal cream: once a day for seven days. 1 applicator (5 gm) of terconazole cream contains 20 mg terconazole. 2. Metronidazole gel: once a day for 5 days. 1 applicator (5 gm)of metronidazole gel contains 37.5 mg metronidazole. 3. Contraceptive IVR: insert ring and leave in place for 21 days; return to clinic for removal on day 21. The IVR contains two active components, etonogestrel (progestin) and ethinyl estradiol (estrogen). Use of TFV gel will begin on day 15 of IVR use.
Drug: Tenofovir 1% gel · Drug: Vaginal product
Also known as: Terconazole 0.4%, Metronidazole gel, Contraceptive IVR
TFV concentrations in plasma and genital tissue and TFV-DP concentrations in genital tissue
Vaginal product alone: Participant will use assigned product per dosing instructions (antifungal cream: 7 days; antimicrobial gel: 5 days; IVR: 21 days). In cream or gel cohorts, blood will be drawn 6 hrs after last use. In contraceptive ring cohort, blood will be drawn after 21 days of use at 0/4,6,10\&24 hrs. TFV gel alone: Participant will use TFV gel for 7 days, inserted 2X a day. In cream/gel cohorts blood will be drawn 4 hrs after last TFV gel use. In contraceptive ring cohort blood will be drawn 4,6,10\&24 hrs after last TFV gel use. Vaginal biopsy will occur 6 hrs after last TFV gel use for all. Vaginal product \& TFV gel: Participant will use assigned product per dosing instructions. TFV gel will be used for 7 days, 2X a day. In gel/cream cohorts blood will be drawn 4 hrs after last TFV gel use. In contraceptive ring cohort blood will be drawn 4,6,10\&24 hrs after last dose of TFV gel. Vaginal biopsy will occur 6 hrs after the last dose of TFV gel for all.
Time frame: Assessments will be after product use (see description)
Vaginal product concentration in plasma
Vaginal product alone: Participant will use assigned product per dosing instructions (antifungal cream: 7 days; antimicrobial gel: 5 days; IVR: 21 days). In cream or gel cohorts, blood will be drawn 6 hrs after last use. In contraceptive ring cohort, blood will be drawn after 21 days of use at 0/4,6,10\&24 hrs. TFV gel alone: Participant will use TFV gel for 7 days, inserted 2X a day. In cream/gel cohorts blood will be drawn 4 hrs after last TFV gel use. In contraceptive ring cohort blood will be drawn 4,6,10\&24 hrs after last TFV gel use. Vaginal product \& TFV gel: Participant will use assigned product per dosing instructions. TFV gel will be used for 7 days, 2X a day. In gel/cream cohorts blood will be drawn 4 hrs after last TFV gel use. In contraceptive ring cohort blood will be drawn 4,6,10\&24 hrs after last dose of TFV gel.
Time frame: Assessments will be after product use (see description)
Genitourinary adverse events (AEs)
Vaginal product alone: Participant will use assigned product per dosing instructions (antifungal cream: 7 days; antimicrobial gel: 5 days; IVR: 21 days). Genitourinary AEs will be assessed by participant report and exam after completion of dosing. TFV gel alone: Participant will use TFV gel for 7 days, inserted 2X a day. Genitourinary AEs will be assessed by participant report and exam after completion of dosing. Vaginal product \& TFV gel: Participant will use assigned product per dosing instructions. TFV gel will be used for 7 days, 2X a day. Genitourinary AEs will be assessed by participant report and exam after completion of dosing.
Time frame: Assessments will be after product use (see description)
This study is completed, as verified in May 2015. You cannot join it, but the record below documents what was studied.
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