Trial Outcomes & Findings for Impact of Menstrual Cycle on Antiretroviral Pharmacokinetics in Healthy Women (NCT NCT00869960)

NCT ID: NCT00869960

Last Updated: 2013-09-06

Results Overview

Systemic exposure determined by area under the concentration time curve was measured by blood drawn for PK assessment at the following times: 0 (time of dose), 0.5, 1, 2, 4,6, 8, 12 and 24 hours. The Follicular phase starts on day 1 of the menstrual cycle when estrogen and progesterone levels are lowest. this lasts 14 days. Dose administration and PK would have been drawn on day 6, 7, 8, 9, or 10 after Day 1 (start of Follicular phase).

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 24 participants
• Primary outcome timeframe: between time of dosing to 24 hours after dose administered
• Results posted on: 2013-09-06

Participant Flow

Participant milestones

Measure	Antiretroviral Therapy Healthy volunteers
Overall Study STARTED	24
Overall Study COMPLETED	22
Overall Study NOT COMPLETED	2

Reasons for withdrawal

Measure	Antiretroviral Therapy Healthy volunteers
Overall Study Lost to Follow-up	2

Baseline Characteristics

Impact of Menstrual Cycle on Antiretroviral Pharmacokinetics in Healthy Women

Baseline characteristics by cohort

Measure	Combination Antiretroviral Therapy n=24 Participants Single dose administration of tenofovir, emtricitabine, atazanavir and ritonavir to healthy women
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	24 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Age Continuous	27 years STANDARD_DEVIATION 5.0 • n=5 Participants
Sex: Female, Male Female	24 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants
Region of Enrollment United States	24 participants n=5 Participants

PRIMARY outcome

Timeframe: between time of dosing to 24 hours after dose administered

Population: The number was determined based upon the those women who completed the study.

Systemic exposure determined by area under the concentration time curve was measured by blood drawn for PK assessment at the following times: 0 (time of dose), 0.5, 1, 2, 4,6, 8, 12 and 24 hours. The Follicular phase starts on day 1 of the menstrual cycle when estrogen and progesterone levels are lowest. this lasts 14 days. Dose administration and PK would have been drawn on day 6, 7, 8, 9, or 10 after Day 1 (start of Follicular phase).

Outcome measures

Measure	Antiretroviral Therapy n=22 Participants Healthy volunteers
Tenofovir Systemic Exposure During the Follicular Phase (Days 6-10 After Menses)	2.4 mg*h/L Standard Deviation 1.1

PRIMARY outcome

Timeframe: between time of dosing tp 24 hours after dose administration

Population: The number was determined based upon the those women who completed the study.

Systemic exposure determined by area under the concentration time curve was measured by blood drawn for PK assessment at the following times: 0 (time of dose), 0.5, 1, 2, 4,6, 8, 12 and 24 hours. The Luteal phase starts on day 14 of the menstrual cycle when estrogen and progesterone levels are beginning to increase. This lasts 14 days or until Day 1 of the Follicular phase. Dose administration and PK during the Luteal phase, would have been drawn on day 20, 21, 22, 23, 24 and 25 start of Follicular phase).

Outcome measures

Measure	Antiretroviral Therapy n=22 Participants Healthy volunteers
Tenofovir Systemic Exposure During the Luteal Phase (Days 20-25 After Menses)	2.2 mg*h/L Standard Deviation 0.07

PRIMARY outcome

Timeframe: Between time of dosing to 24 hours after dose administration

Population: The number was determined based upon the those women who completed the study.

Systemic exposure determined by area under the concentration time curve was measured by blood drawn for PK assessment at the following times: 0 (time of dose), 0.5, 1, 2, 4,6, 8, 12 and 24 hours. The Follicular phase starts on day 1 of the menstrual cycle when estrogen and progesterone levels are lowest. this lasts 14 days. Dose administration and PK would have been drawn on day 6, 7, 8, 9, or 10 after Day 1 (start of Follicular phase).

Outcome measures

Measure	Antiretroviral Therapy n=22 Participants Healthy volunteers
Emtricitabine Systemic Exposure During the Follicular Phase (Days 6-10 After Menses)	11.2 mg*h/L Standard Deviation 4.4

PRIMARY outcome

Timeframe: Between time of dosing to 24 hours after dose administration

Population: The number was determined based upon the those women who completed the study.

Systemic exposure determined by area under the concentration time curve was measured by blood drawn for PK assessment at the following times: 0 (time of dose), 0.5, 1, 2, 4,6, 8, 12 and 24 hours. The Luteal phase starts on day 14 of the menstrual cycle when estrogen and progesterone levels are beginning to increase. This lasts 14 days or until Day 1 of the Follicular phase. Dose administration and PK during the Luteal phase, would have been drawn on day 20, 21, 22, 23, 24 and 25 start of Follicular phase).

Outcome measures

Measure	Antiretroviral Therapy n=22 Participants Healthy volunteers
Emtricitabine Systemic Exposure During the Luteal Phase (Days 20-25 After Menses)	10.2 mg*h/L Standard Deviation 3.7

PRIMARY outcome

Timeframe: Between time of dosing to 24 hours after dose administration

Population: The number was determined based upon the those women who completed the study.

Systemic exposure determined by area under the concentration time curve was measured by blood drawn for PK assessment at the following times: 0 (time of dose), 0.5, 1, 2, 4,6, 8, 12 and 24 hours. The Follicular phase starts on day 1 of the menstrual cycle when estrogen and progesterone levels are lowest. this lasts 14 days. Dose administration and PK would have been drawn on day 6, 7, 8, 9, or 10 after Day 1 (start of Follicular phase).

Outcome measures

Measure	Antiretroviral Therapy n=22 Participants Healthy volunteers
Atazanavir Systemic Exposure During the Follicular Phase (Days 6-10 After Menses)	23.9 mg*h/L Standard Deviation 13.5

PRIMARY outcome

Timeframe: Between time of dosing to 24 hours after dose administration

Population: The number was determined based upon the those women who completed the study.

Systemic exposure determined by area under the concentration time curve was measured by blood drawn for PK assessment at the following times: 0 (time of dose), 0.5, 1, 2, 4,6, 8, 12 and 24 hours. The Luteal phase starts on day 14 of the menstrual cycle when estrogen and progesterone levels are beginning to increase. This lasts 14 days or until Day 1 of the Follicular phase. Dose administration and PK during the Luteal phase, would have been drawn on day 20, 21, 22, 23, 24 and 25 start of Follicular phase).

Outcome measures

Measure	Antiretroviral Therapy n=22 Participants Healthy volunteers
Atazanavir Systemic Exposure During the Luteal Phase (Days 20-25 After Menses)	22.4 mg*h/L Standard Deviation 9.1

PRIMARY outcome

Timeframe: Between time of dosing to 24 hours after dose administration

Population: The number was determined based upon the those women who completed the study.

Systemic exposure determined by area under the concentration time curve was measured by blood drawn for PK assessment at the following times: 0 (time of dose), 0.5, 1, 2, 4,6, 8, 12 and 24 hours. The Follicular phase starts on day 1 of the menstrual cycle when estrogen and progesterone levels are lowest. this lasts 14 days. Dose administration and PK would have been drawn on day 6, 7, 8, 9, or 10 after Day 1 (start of Follicular phase).

Outcome measures

Measure	Antiretroviral Therapy n=22 Participants Healthy volunteers
Ritonavir Systemic Exposure During the Follicular Phase (Days 6-10 After Menses)	7.2 mg*h/L Standard Deviation 3.6

PRIMARY outcome

Timeframe: Between time of dosing to 24 hours after dose administration

Population: The number was determined based upon the those women who completed the study.

Systemic exposure determined by area under the concentration time curve was measured by blood drawn for PK assessment at the following times: 0 (time of dose), 0.5, 1, 2, 4,6, 8, 12 and 24 hours. The Luteal phase starts on day 14 of the menstrual cycle when estrogen and progesterone levels are beginning to increase. This lasts 14 days or until Day 1 of the Follicular phase. Dose administration and PK during the Luteal phase, would have been drawn on day 20, 21, 22, 23, 24 and 25 start of Follicular phase).

Outcome measures

Measure	Antiretroviral Therapy n=22 Participants Healthy volunteers
Ritonavir Systemic Exposure During the Luteal Phase (Days 20-25 After Menses)	6.7 mg*h/L Standard Deviation 3.1

Adverse Events

Antiretroviral Therapy

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Jennifer King

UAB

Phone: 205-934-2696

Email: jenking@uab.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place