The Effect of Intermittent Rifampicin on Raltegravir

NCT01424826 | Completed Phase 1 DMC

• 2 other identifiers: UoL0006432010-021461-73
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

Brief Summary

This study seeks to address the question of whether intermittent dosing of rifampicin influences the pharmacokinetics of raltegravir when co-administered. This study aims to look at what happens when rifampicin is taken 3 times a week with the standard dose and an increased dose of raltegravir. This is to find out the best dose of raltegravir to take when taking rifampicin 3 times a week. The study will be conducted in 18 healthy volunteers.

Conditions

HIV; Tuberculosis

Keywords

Healthy volunteers

Outcome Measures

Primary Outcomes (1)

• Change in raltegravir area under the curve (AUC) 0-12h

  Day 28 and day 33

Secondary Outcomes (1)

• Number of participants with adverse events

  40 days (up to + 7 days)

Interventions

Raltegravir DRUG

400 mg bd for minimum of 28 days and maximum 35 days

Rifampicin DRUG

\< 50 kg 600 mg 3 times/week for a minimum of 27 days and maximum of 34 days \> 50 kg 900 mg 3 times/week for a minimum of 27 days and maximum of 34 days

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• The ability to understand and sign a written informed consent form, prior to participation in any screening procedures and must be willing to comply with all study requirements.
• ≥ 18 years
• Male or female subjects
• A female may be eligible to enter and participate in the study if she:
• Is of non-child-bearing potential defined as ether post-menopausal (12 months of spontaneous amenorrhea and ≥ 45 years of age)or physically incapable of becoming pregnant with documented tubal ligation, hysterectomy or bilateral oophorectomy or
• Is of child-bearing potential with a negative pregnancy test at screening and agrees to use one of the following methods of contraception to avoid pregnancy
• Complete abstinence from intercourse from 2 weeks prior to administration of IP, throughout the study and for at least 4 weeks after discontinuation of all study medication
• Double barrier method (male condom/spermicide, male condom/diaphragm, diaphragm/spermicide)
• Any intrauterine device (IUD) with published data showing that the expected failure rate is \< 1 % per year
• Any other method with published data showing that the expected failure rate is \< 1 % PER YEAR
• All subjects participating in the study will be counseled on safer sexual practices including the use of effective barrier methods (e.g. male condom)

You may not qualify if:

• Any significant acute or chronic medical condition
• Pregnant or lactating women
• Women of childbearing age unless using non hormonal contraception
• Males who are not using contraception
• Evidence of organ dysfunction or any clinically significant deviation from normal during screening including laboratory determinations such as abnormal LFTs
• Positive blood screen for HIV-1 and 2 antibodies
• Positive blood screen for hepatitis B or C antibodies
• Positive IGRA screen for TB
• Current or recent (within 3 months) gastrointestinal disease
• Clinically relevant alcohol or drug use or history of alcohol or drug use that will hinder compliance with treatment, follow up procedures or evaluation of adverse effects
• Use of proton pump inhibitors
• Exposure to any investigational drug or placebo within 4 weeks of first dose of study drug
• Consumption of grapefruit and Seville oranges or products containing grapefruit or Seville oranges within 1 week of first study drug and for the duration of the study
• Use of any other drugs including over-the-counter medications and herbal preparations, within 2 weeks prior to first dose of study drug
• Previous allergy to any of the constituents of the pharmaceuticals in this trial

Sponsors & Collaborators

• Helen Reynolds: lead
• Liverpool University Hospitals NHS Foundation Trust: collaborator

Study Sites (1)

Royal Liverpool & Broadgreen Univeristy Hospitals NHS Trust

Liverpool, L7 8XP, United Kingdom

Location

Related Publications (1)

• Reynolds HE, Chrdle A, Egan D, Chaponda M, Else L, Chiong J, Back DJ, Khoo SH. Effect of intermittent rifampicin on the pharmacokinetics and safety of raltegravir. J Antimicrob Chemother. 2015 Feb;70(2):550-4. doi: 10.1093/jac/dku376. Epub 2014 Sep 26.

  PMID: 25261424 DERIVED

MeSH Terms

Conditions

Tuberculosis

Interventions

Raltegravir Potassium; Rifampin

Condition Hierarchy (Ancestors)

Mycobacterium Infections; Actinomycetales Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections

Intervention Hierarchy (Ancestors)

Pyrrolidinones; Pyrrolidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Rifamycins; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Lactams, Macrocyclic; Macrocyclic Compounds; Polycyclic Compounds

Study Officials

• Saye Khoo

  University of Liverpool

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Research Nurse

Study Record Dates

• First Submitted: August 24, 2011
• First Posted: August 29, 2011
• Study Start: January 1, 2012
• Primary Completion: June 1, 2013
• Study Completion: July 1, 2013
• Last Updated: October 31, 2013

Record last verified: 2013-10

Locations

GB (1)