Trial Outcomes & Findings for Characterization and Modulation of Mucosal Immunity for HIV Prevention in Women (NCT NCT02333045)

Last Updated: 2018-01-19

Results Overview

The count of CCR5+CD4+ T cells in the genital tract, before participants began study treatment, after 7 days of treatment, and during the post-treatment drug elimination period. The precise role of CCR5+CD4+ T cells in the female genital tract is unknown, however, higher cell counts may suggest the potential for more HIV target cells in the genital tract.

Recruitment status

TERMINATED

Study phase

Target enrollment

4 participants

Primary outcome timeframe

Baseline, Day 7, Day 14, Day 21

Results posted on

2018-01-19

Participant Flow

Participant milestones

Participant milestones
Measure	Truvada Women randomized to receive one tablet of Truvada (200mg emtricitabine/300mg tenofovir) daily for 7 days.	Maraviroc Women randomized to receive 300mg of Maraviroc daily for 7 days.
Overall Study STARTED	1	3
Overall Study COMPLETED	1	3
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Characterization and Modulation of Mucosal Immunity for HIV Prevention in Women

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Truvada n=1 Participants Women randomized to receive one tablet of Truvada (200mg emtricitabine/300mg tenofovir) daily for 7 days.	Maraviroc n=3 Participants Women randomized to receive 300mg of Maraviroc daily for 7 days.	Total n=4 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Age, Categorical Between 18 and 65 years	1 Participants n=93 Participants	3 Participants n=4 Participants	4 Participants n=27 Participants
Age, Categorical >=65 years	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Sex: Female, Male Female	1 Participants n=93 Participants	3 Participants n=4 Participants	4 Participants n=27 Participants
Sex: Female, Male Male	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	1 Participants n=93 Participants	3 Participants n=4 Participants	4 Participants n=27 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race (NIH/OMB) Asian	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race (NIH/OMB) Black or African American	0 Participants n=93 Participants	3 Participants n=4 Participants	3 Participants n=27 Participants
Race (NIH/OMB) White	1 Participants n=93 Participants	0 Participants n=4 Participants	1 Participants n=27 Participants
Race (NIH/OMB) More than one race	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Region of Enrollment United States	1 Participants n=93 Participants	3 Participants n=4 Participants	4 Participants n=27 Participants

PRIMARY outcome

Timeframe: Baseline, Day 7, Day 14, Day 21

Population: The analysis includes all available data collected during each study visit. Not all participants provided a sample at every study visit.

Outcome measures

Outcome measures
Measure	Truvada n=1 Participants Women randomized to receive one tablet of Truvada (200mg emtricitabine/300mg tenofovir) daily for 7 days.	Maraviroc n=3 Participants Women randomized to receive 300mg of Maraviroc daily for 7 days.
Count of Total Cells Obtained From Cervicovaginal Lavage Samples Day 14	20,000,000 cells Standard Deviation 0.0	28,300,000 cells Standard Deviation 8,500,000
Count of Total Cells Obtained From Cervicovaginal Lavage Samples Day 21	30,000,000 cells Standard Deviation 0.0	21,800,000 cells Standard Deviation 13,200,000
Count of Total Cells Obtained From Cervicovaginal Lavage Samples Baseline	42,000,000 cells Standard Deviation 0.0	20,000,000 cells Standard Deviation 0.0
Count of Total Cells Obtained From Cervicovaginal Lavage Samples Day 7	15,000,000 cells Standard Deviation 0.0	18,700,000 cells Standard Deviation 7,500,000

SECONDARY outcome

Timeframe: 7 days

Population: Data were not collected at each visit as some participants declined providing samples. Due to the small number of observations, study drug concentrations were not determined for the samples provided.

Study drug concentrations will be measured from blood.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 7 days

Study drug concentrations will be measured from female genital tract.

Outcome measures

Outcome data not reported

Adverse Events

Truvada

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Maraviroc

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

Anandi Sheth, MD

Emory University

Phone: 404-616-6240

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place