The Raltegravir and Ribavirin Pharmacokinetics (PK) Study

NCT00982553 | Completed Phase 1 Results

• 1 other identifier: 2009-010005-36
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to look at levels of both a new anti-HIV drug called raltegravir and an existing anti-hepatitis C drug called ribavirin to see if they affect the blood levels of each other when given separately and together. This is a phase I, open-label, prospective, three phase, pharmacokinetic study.

Conditions

HIV Infections

Keywords

Healthy Volunteers

Outcome Measures

Primary Outcomes (4)

• Ribavirin Maximum Plasma Concentration

  Pharmacokinetic analyses of blood samples

  Day 20

• Raltegravir Maximum Plasma Concentration

  Day 20

• Ribavirin Minimum Plasma Concentration

  Ribavirin minimum plasma concentration by pharmacokinetic analyses

  Day 20

• Raltegravir Minimum Plasma Concentrations

  Raltegravir minimum plasma concentrations by pharmacokinetic analyses

  Day 20

Study Arms (3)

Phase 1_ribavirin

EXPERIMENTAL

Treatment with Single dose ribavirin (800 mg) administered on day 1

Drug: Ribavirin

Phase2_raltegravir

EXPERIMENTAL

Treatment with Raltegravir (400 mg twice daily) administered from days 15-19

Drug: Raltegravir

Phase3_ribavirin+raltegravir

EXPERIMENTAL

Treatment with Ribavirin (800 mg) and Raltegravir (400 mg) administered day 20

Drug: Ribavirin; Drug: Raltegravir

Interventions

Ribavirin DRUG

800mg once daily

Also known as: Copegus

Phase 1_ribavirin; Phase3_ribavirin+raltegravir

Raltegravir DRUG

400mg twice daily

Phase2_raltegravir; Phase3_ribavirin+raltegravir

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

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.
• Male or non-pregnant, non-lactating female.
• Between 18 to 60 years, inclusive.
• Subjects in good health upon medical history, physical exam, and laboratory testing and body mass index below 32.
• Female subjects who are heterosexually active and of childbearing potential (i.e., not surgically sterile or at least two years post menopausal) must practice contraception as follows from screening through completion of the study including 180 days following last dose of study drug:
• barrier contraceptives (condom, diaphragm with spermicide)
• oral combined contraceptive pill, implant or injectable hormonal contraceptive PLUS a barrier contraceptive
• Intrauterine device (IUD) or intrauterine system (IUS) PLUS a barrier contraceptive (or a partner who has been vasectomized for at least six months).
• Female subjects of childbearing potential must have a negative urine pregnancy test.
• Male subjects who are heterosexually active must use two forms of barrier contraception (e.g., condom with spermicide) during heterosexual intercourse, from screening through completion of the study including 180 days following last dose of study drug.
• Have no serologic evidence of HIV infection.
• Have no serologic evidence of active hepatitis B virus infection evidenced by negative hepatitis B surface antigen and no serologic evidence of hepatitis C virus infection through antibody testing.
• Have screening laboratory results (haematology, chemistry) that fall within the normal range of the central laboratory's reference ranges unless the results have been determined by the Investigator to have no clinical significance.

You may not qualify if:

• Any serious or active medical or psychiatric illness which, in the opinion of the Investigator, would interfere with subject treatment, assessment, or compliance with the protocol. This would include any active clinically significant renal, cardiac, hepatic, pulmonary, vascular, metabolic (thyroid disorders, adrenal disease), immunodeficiency disorders, active infection, or malignancy.
• Have a body mass index (BMI) greater than 32
• Previous participation in an investigational trial involving administration of any investigational compound within 1 month prior to the study screening.
• Clinically relevant alcohol or drug use (positive screening drug screen) or history of alcohol or drug use considered by the Investigator to be sufficient to hinder compliance with treatment, follow-up procedures or evaluation of adverse events. Smoking is permitted, but tobacco intake should remain consistent throughout the study.
• Any medication taken listed in Prior and Concomitant Medication section including over-the-counter medications and herbal products within 21 days of commencing study drug dosing with the exception of vitamins and/or paracetamol and/or hormonal contraceptives including the combined oral contraceptive pill, Depo-Provera and the Mirena intrauterine system. When a concomitant medication is necessary, this will be reviewed by the Investigator and if not contraindicated, may be continued at the same dose and frequency during the study period.
• History of drug sensitivity or drug allergy.

Sponsors & Collaborators

• Imperial College London: lead

Study Sites (1)

Imperial College Healthcare NHS Trust

London, W2 1NY, United Kingdom

Location

Related Publications (1)

• Ashby J, Garvey L, Erlwein OW, Lamba H, Weston R, Legg K, Latch N, McClure MO, Dickinson L, D'Avolio A, Back D, Winston A. Pharmacokinetic and safety profile of raltegravir and ribavirin, when dosed separately and together, in healthy volunteers. J Antimicrob Chemother. 2011 Jun;66(6):1340-5. doi: 10.1093/jac/dkr093. Epub 2011 Mar 15.

  PMID: 21406434 RESULT

MeSH Terms

Conditions

HIV Infections

Interventions

Ribavirin; Raltegravir Potassium

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Intervention Hierarchy (Ancestors)

Ribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Pyrrolidinones; Pyrrolidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Dr Alan Winston
• Organization: Imperial College

a.winston@imperial.ac.uk

+44 (0)20 3312 1603

Study Officials

• Alan Winston, MB BH

  Imperial College London

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 22, 2009
• First Posted: September 23, 2009
• Study Start: September 1, 2009
• Primary Completion: November 1, 2009
• Study Completion: December 1, 2009
• Last Updated: October 11, 2019
• Results First Posted: June 13, 2011

Record last verified: 2019-09

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)