Trial Outcomes & Findings for Comparing Raltegravir Genital Tract Distribution in HIV-infected Men and Women (NCT NCT00745368)

NCT ID: NCT00745368

Last Updated: 2012-10-10

Results Overview

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 28 participants
• Primary outcome timeframe: 8-10 hours after raltegravir dose
• Results posted on: 2012-10-10

Participant Flow

Participant milestones

Measure	Raltegravir Raltegravir 400 mg tablets twice daily
Overall Study STARTED	19
Overall Study COMPLETED	16
Overall Study NOT COMPLETED	3

Reasons for withdrawal

Measure	Raltegravir Raltegravir 400 mg tablets twice daily
Overall Study Unable to provide sample	3

Baseline Characteristics

Comparing Raltegravir Genital Tract Distribution in HIV-infected Men and Women

Baseline characteristics by cohort

Measure	Raltegravir n=16 Participants Raltegravir 400 mg tablets twice daily
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	16 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Age Continuous	47 years STANDARD_DEVIATION 8.8 • n=5 Participants
Sex: Female, Male Female	8 Participants n=5 Participants
Sex: Female, Male Male	8 Participants n=5 Participants
Region of Enrollment United States	16 participants n=5 Participants

PRIMARY outcome

Timeframe: 8-10 hours after raltegravir dose

Outcome measures

Measure	Raltegravir n=8 Participants Raltegravir 400 mg tablets twice daily
Raltegravir Male Genital Tract Concentration	485.1 ng/mL Interval 428.5 to 753.3

PRIMARY outcome

Timeframe: 8-10 hours after raltegravir dose

Outcome measures

Measure	Raltegravir n=8 Participants Raltegravir 400 mg tablets twice daily
Raltegravir Female Genital Tract Concentration	879.1 ng/mL Interval 128.4 to 3541.4

PRIMARY outcome

Timeframe: 8-10 hours after raltegravir dose

This sample was taken as close to the time of genital tract sample as possible

Outcome measures

Measure	Raltegravir n=8 Participants Raltegravir 400 mg tablets twice daily
Male Paired Plasma Concentration	172 ng/mL Interval 104.3 to 231.0

PRIMARY outcome

Timeframe: 8-10 hours after raltegravir dose

This sample was taken as close to the time of genital tract sample as possible

Outcome measures

Measure	Raltegravir n=8 Participants Raltegravir 400 mg tablets twice daily
Female Paired Plasma Concentration	264.6 ng/mL Interval 129.4 to 1256.7

PRIMARY outcome

Timeframe: 8-10 hours after raltegravir dose

This measure describes the amount of time that expired between when the dose was administered and when the sample was taken

Outcome measures

Measure	Raltegravir n=8 Participants Raltegravir 400 mg tablets twice daily
Male Time Since Last Dose	8.0 hours Interval 8.0 to 8.1

PRIMARY outcome

Timeframe: 8-10 hours after raltegravir dose

This measure describes the amount of time that expired between when the dose was administered and when the sample was taken

Outcome measures

Measure	Raltegravir n=8 Participants Raltegravir 400 mg tablets twice daily
Female Time Since Last Dose	8.5 hours Interval 8.2 to 8.6

PRIMARY outcome

Timeframe: 8-10 hours after raltegravir dose

Units of raltegravir concentration for genital tract and plasma sample are ng/mL

Outcome measures

Measure	Raltegravir n=8 Participants Raltegravir 400 mg tablets twice daily
Male Genital Tract:Plasma Concentration Ratio	4.3 ratio Interval 2.7 to 5.9

PRIMARY outcome

Timeframe: 8-10 hours after raltegravir dose

Units of raltegravir concentration for genital tract and plasma sample are ng/mL

Outcome measures

Measure	Raltegravir n=8 Participants Raltegravir 400 mg tablets twice daily
Female Genital Tract:Plasma Concentration Ratio	2.2 ratio Interval 0.6 to 5.6

Adverse Events

Raltegravir

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

Robert DiCenzo

University of Rochester

Phone: 518 694 7228

Email: rob.dicenzo@acphs.edu

Results disclosure agreements

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

Restriction type: LTE60