Trial Outcomes & Findings for Levels of Raltegravir in the Female Genital Tissue (NCT NCT01327482)

NCT ID: NCT01327482

Last Updated: 2014-12-19

Results Overview

Mean trough concentration from all three days. Tissue concentrations are measured from cervical biopsy homogenate using a mass-spectroscopy-based method.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 10 participants
• Primary outcome timeframe: 7, 14, 21 days
• Results posted on: 2014-12-19

Participant Flow

Participant milestones

Measure	Raltegravir Healthy volunteers who had regular menses and were not on hormonal contraception
Overall Study STARTED	10
Overall Study COMPLETED	9
Overall Study NOT COMPLETED	1

Reasons for withdrawal

Measure	Raltegravir Healthy volunteers who had regular menses and were not on hormonal contraception
Overall Study Adverse Event	1

Baseline Characteristics

Levels of Raltegravir in the Female Genital Tissue

Baseline characteristics by cohort

Measure	Raltegravir n=10 Participants Healthy volunteers who had regular menses and were not on hormonal contraception
Age, Continuous	30 years STANDARD_DEVIATION 8 • n=5 Participants
Sex: Female, Male Female	10 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants
Region of Enrollment United States	10 participants n=5 Participants

PRIMARY outcome

Timeframe: 7, 14, 21 days

Mean trough concentration from all three days. Tissue concentrations are measured from cervical biopsy homogenate using a mass-spectroscopy-based method.

Outcome measures

Measure	Raltegravir n=10 Participants Healthy volunteers who had regular menses and were not on hormonal contraception
Tissue Raltegravir Concentrations	117 ng/mL Standard Deviation 229

SECONDARY outcome

Timeframe: 7, 14, 21 days

Mean trough concentration from all 3 days

Outcome measures

Measure	Raltegravir n=10 Participants Healthy volunteers who had regular menses and were not on hormonal contraception
Plasma Raltegravir Concentrations	160 ng/mL Standard Deviation 394

Adverse Events

Raltegravir

Serious events: 0 serious events

Other events: 4 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Raltegravir n=10 participants at risk Healthy volunteers who had regular menses and were not on hormonal contraception
Gastrointestinal disorders Nausea	20.0% 2/10 • Number of events 2
Gastrointestinal disorders Vomiting	10.0% 1/10 • Number of events 1
Musculoskeletal and connective tissue disorders Knee pain	10.0% 1/10 • Number of events 1
Gastrointestinal disorders Dry mouth	20.0% 2/10 • Number of events 2

Additional Information

Dr. Caroline Mitchell

Massachusetts General Hospital

Phone: 617-724-2182

Email: caroline.mitchell@mgh.harvard.edu

Results disclosure agreements

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