Trial Outcomes & Findings for Buprenorphine/Raltegravir Pharmacokinetic Interaction Study (NCT NCT00858962)

Results Overview

PK parameters of BUP were determined by non-compartmental methods. AUC of BUP was determined by use of the trapezoidal rule.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

12 participants

Primary outcome timeframe

6-14 days after beginning co-administration of drugs

Results posted on

2012-11-21

Participant milestones
Measure	Raltegravir (400mg Twice Per Day) Subjects were maintained on Buprenorphine/Naloxone (BUP/NLX) for 3 weeks prior to Raltegravir administration to achieve steady state during baseline. Subsequently, subjects were co-administered raltegravir (400mg twice per day)and BUP/NLX. All subjects received 16/4 mg of BUP/NLX daily, except for 1 patient who received 32/8 mg daily.
Overall Study STARTED	12
Overall Study COMPLETED	12
Overall Study NOT COMPLETED	0

Withdrawal data not reported

Buprenorphine/Raltegravir Pharmacokinetic Interaction Study

Baseline characteristics by cohort
Measure	Raltegravir (400mg Twice Per Day) n=12 Participants Subjects were maintained on Buprenorphine/Naloxone (BUP/NLX) for 3 weeks prior to Raltegravir administration to achieve steady state during baseline. Subsequently, subjects were co-administered raltegravir (400mg twice per day)and BUP/NLX. All subjects received 16/4 mg of BUP/NLX daily, except for 1 patient who received 32/8 mg daily.
Age Continuous	44 years n=5 Participants
Sex: Female, Male Female	4 Participants n=5 Participants
Sex: Female, Male Male	8 Participants n=5 Participants
Region of Enrollment United States	12 participants n=5 Participants

Timeframe: 6-14 days after beginning co-administration of drugs

Population: All subjects who completed study were included in the analysis.

PK parameters of BUP were determined by non-compartmental methods. AUC of BUP was determined by use of the trapezoidal rule.

Outcome measures
Measure	Raltegravir (400mg Twice Per Day) n=12 Participants Subjects were maintained on Buprenorphine/Naloxone (BUP/NLX) for 3 weeks prior to Raltegravir administration to achieve steady state during baseline. Subsequently, subjects were co-administered raltegravir (400mg twice per day)and BUP/NLX. All subjects received 16/4 mg of BUP/NLX daily, except for 1 patient who received 32/8 mg daily.
Area Under the Curve (AUC) of BUP/NLX With Raltegravir (hr*ng/mL)	56.0 hr*ng/mL Standard Deviation 17.1

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Adverse event data not reported

Adverse event data not reported

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