N/A N=12 Basic Science

Pharmacokinetic Interactions Between Buprenorphine and Tipranavir/Ritonavir

HIV Infections

Bottom Line

View on ClinicalTrials.gov: NCT00486330 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Nov 2012

Primary outcome: Primary: Area Under the Curve of BUP/NLX With TPV/r (h*ng/mL) — 43.7 h*ng/mL

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Buprenorphine, Tipranavir and ritonavir (Drug)
Age: Adult · 18+ yrs
Sex: All
Sponsor: Yale University
Primary completion: May 2007

Outcome Measures

Outcome	Result	p-value
PRIMARY Area Under the Curve of BUP/NLX With TPV/r (h*ng/mL)	43.7	—

Summary

The main purpose of this study is to examine the effect of tipranavir combined with ritonavir, medications for the treatment of HIV-infection, on buprenorphine/naloxone (BUP) in people who have been receiving the same dose of buprenorphine/naloxone for at least 3 weeks before study entry.

Eligibility Criteria

Inclusion Criteria

Buprenorphine/naloxone (BUP/NAL) users (taking 16/4 mg sublingually daily) for at least 3 weeks deemed by the investigator to have acceptable medical history, physical examination, 12 lead electrocardiogram, and clinical laboratory evaluations consistent with BUP maintenance will be eligible to participate in the study.
Subjects who meet the criteria of opiate dependence, are enrolled in long-term BUP maintenance therapy, and have been on a stable dose of BUP/NAL for at least 3 weeks.
Body weight > 60 kg for males and > 40 kg for females
Body Mass Index (BMI) of 18 to 30 kg/m2, inclusive. BMI = weight (kg)/ [height(m)]2.
Male or females, ages > 18 to 2.5X the upper limit of normal.
Hemoglobin < 9 g/dL, and platelet count < 75, 000/mm3.
Positive serum or urine for HCG.
History of any significant drug allergy, drug rash or sensitivity to any class of drugs relevant to the study drugs.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00486330). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.