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The Raltegravir and Ribavirin Pharmacokinetics (PK) Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00982553
Recruitment Status : Completed
First Posted : September 23, 2009
Results First Posted : June 13, 2011
Last Update Posted : October 11, 2019
Information provided by (Responsible Party):
Imperial College London

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.

Condition or disease Intervention/treatment Phase
HIV Infections Drug: Ribavirin Drug: Raltegravir Phase 1

Detailed Description:

Phase I (study day 1 - 14):

  • 14 healthy volunteers with a documented negative HIV-1 antibody test during screening procedures will be enrolled.
  • On day 1, fasted subjects will be administered ribavirin 800 mg without food (witnessed dosing). This will be followed be a 12 hour detailed pharmacokinetic assessment; blood sampling drawn at 0 (pre-dose), 0.5, 1, 2, 3, 4, 6, 8 and 12 hours.
  • This will be followed by a wash-out period.
  • As steady state pharmacokinetics of ribavirin are not reached for several weeks, single dosing pharmacokinetics will be assessed in this study

Phase II (study days 15 - 19):

  • On day 15, subjects will commence raltegravir 400 mg twice daily. Subjects will attend for safety visits and witnessed dosing during this phase.
  • Day 19 - after 4 days of dosing when steady state pharmacokinetics has been reached, subjects will attend for a 12 hour detailed pharmacokinetic visit where following witnessed administration of raltegravir 400 mg without food, blood sampling will be drawn at 0 (pre-dose), 0.5, 1, 2, 3, 4, 6, 8 and 12 hours post dose for the assessment of raltegravir plasma exposure.

Phase III (study day 20):

• Subjects will be administered raltegravir 400 mg and ribavirin 800 mg without food. This will be followed by a 12 hour detailed pharmacokinetic assessment with blood sampling drawn at 0 (pre-dose), 0.5, 1, 2, 3, 4, 6, 8, and 12 hours.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 14 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Prospective, Open-label, Three Phase Pharmacokinetic Study, to Assess the Pharmacokinetic Profile and Safety of Raltegravir 400 mg Twice Daily and Ribavirin 800 mg Once Daily, When Dosed Separately and Together in Healthy Volunteers
Study Start Date : September 2009
Actual Primary Completion Date : November 2009
Actual Study Completion Date : December 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

Arm Intervention/treatment
Experimental: Phase 1_ribavirin
Treatment with Single dose ribavirin (800 mg) administered on day 1
Drug: Ribavirin
800mg once daily
Other Name: Copegus

Experimental: Phase2_raltegravir
Treatment with Raltegravir (400 mg twice daily) administered from days 15-19
Drug: Raltegravir
400mg twice daily

Experimental: Phase3_ribavirin+raltegravir
Treatment with Ribavirin (800 mg) and Raltegravir (400 mg) administered day 20
Drug: Ribavirin
800mg once daily
Other Name: Copegus

Drug: Raltegravir
400mg twice daily

Primary Outcome Measures :
  1. Ribavirin Maximum Plasma Concentration [ Time Frame: Day 20 ]
    Pharmacokinetic analyses of blood samples

  2. Raltegravir Maximum Plasma Concentration [ Time Frame: Day 20 ]
  3. Ribavirin Minimum Plasma Concentration [ Time Frame: Day 20 ]
    Ribavirin minimum plasma concentration by pharmacokinetic analyses

  4. Raltegravir Minimum Plasma Concentrations [ Time Frame: Day 20 ]
    Raltegravir minimum plasma concentrations by pharmacokinetic analyses

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00982553

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United Kingdom
Imperial College Healthcare NHS Trust
London, United Kingdom, W2 1NY
Sponsors and Collaborators
Imperial College London
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Principal Investigator: Alan Winston, MB BH Imperial College London
Publications of Results:
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Responsible Party: Imperial College London Identifier: NCT00982553    
Other Study ID Numbers: 2009-010005-36
2009-010005-36 ( EudraCT Number )
First Posted: September 23, 2009    Key Record Dates
Results First Posted: June 13, 2011
Last Update Posted: October 11, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Imperial College London:
Healthy Volunteers
Additional relevant MeSH terms:
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HIV Infections
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Raltegravir Potassium
Molecular Mechanisms of Pharmacological Action
Antiviral Agents
Anti-Infective Agents
Anti-HIV Agents
Anti-Retroviral Agents
HIV Integrase Inhibitors
Integrase Inhibitors
Enzyme Inhibitors