Trial Outcomes & Findings for Study of How Bacterial Vaginosis and Its Treatment Affects Cervical and Vaginal Tissue (NCT NCT01347632)

NCT ID: NCT01347632

Last Updated: 2017-12-19

Results Overview

The study will evaluate HIV infection and safety of cervico-vaginal tissue in women at 3 different time periods: 1. During a BV infection 2. Approximately 1 week after completing a 7-day course of metronidazole therapy 3. Approximately 1 month after completing the 7-day course of metronidazole therapy Each of the 33 participants were sampled at baseline (during BV infection), approximately 1 week after treatment and approximately 1 month after treatment. p 24 antigen data was not evaluable in this study due to the fact that the samples were frozen prior to laboratory analyses, which damaged the samples. No data were collected.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 35 participants
• Primary outcome timeframe: 6 weeks
• Results posted on: 2017-12-19

Participant Flow

Recruitment for 6 months

Participant milestones

Measure	Metronidazole Open Label Study
Overall Study STARTED	35
Overall Study COMPLETED	33
Overall Study NOT COMPLETED	2

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Study of How Bacterial Vaginosis and Its Treatment Affects Cervical and Vaginal Tissue

Baseline characteristics by cohort

Measure	Metronidazole n=35 Participants Open Label Study
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	35 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Age, Continuous	33 years STANDARD_DEVIATION 2 • n=5 Participants
Sex: Female, Male Female	35 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants
Region of Enrollment United States	35 participants n=5 Participants

PRIMARY outcome

Timeframe: 6 weeks

The study will evaluate HIV infection and safety of cervico-vaginal tissue in women at 3 different time periods:

1. During a BV infection

2. Approximately 1 week after completing a 7-day course of metronidazole therapy

3. Approximately 1 month after completing the 7-day course of metronidazole therapy

Each of the 33 participants were sampled at baseline (during BV infection), approximately 1 week after treatment and approximately 1 month after treatment. p 24 antigen data was not evaluable in this study due to the fact that the samples were frozen prior to laboratory analyses, which damaged the samples. No data were collected.

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: 30 days

p 24 antigen data was not evaluable in this study due to the fact that the samples were frozen prior to laboratory analyses.

Outcome measures

Outcome data not reported

Adverse Events

Metronidazole

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Metronidazole n=35 participants at risk Open Label Study
Gastrointestinal disorders Nausea	5.7% 2/35 • Number of events 2 • 1 year

Additional Information

Andrea Thurman

CONRAD

Phone: 757-446-7444

Email: thurmaar@evms.edu

Results disclosure agreements

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