- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00982553
The Raltegravir and Ribavirin Pharmacokinetics (PK) Study
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 Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Phase 1
Contacts and Locations
Study Locations
-
-
-
London, United Kingdom, W2 1NY
- Imperial College Healthcare NHS Trust
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Phase 1_ribavirin
Treatment with Single dose ribavirin (800 mg) administered on day 1
|
800mg once daily
Other Names:
|
Experimental: Phase2_raltegravir
Treatment with Raltegravir (400 mg twice daily) administered from days 15-19
|
400mg twice daily
|
Experimental: Phase3_ribavirin+raltegravir
Treatment with Ribavirin (800 mg) and Raltegravir (400 mg) administered day 20
|
400mg twice daily
800mg once daily
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Ribavirin Maximum Plasma Concentration
Time Frame: Day 20
|
Pharmacokinetic analyses of blood samples
|
Day 20
|
Raltegravir Maximum Plasma Concentration
Time Frame: Day 20
|
Day 20
|
|
Ribavirin Minimum Plasma Concentration
Time Frame: Day 20
|
Ribavirin minimum plasma concentration by pharmacokinetic analyses
|
Day 20
|
Raltegravir Minimum Plasma Concentrations
Time Frame: Day 20
|
Raltegravir minimum plasma concentrations by pharmacokinetic analyses
|
Day 20
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Alan Winston, MB BH, Imperial College London
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- RNA Virus Infections
- Virus Diseases
- Infections
- Blood-Borne Infections
- Communicable Diseases
- Sexually Transmitted Diseases, Viral
- Sexually Transmitted Diseases
- Lentivirus Infections
- Retroviridae Infections
- Immunologic Deficiency Syndromes
- Immune System Diseases
- HIV Infections
- Molecular Mechanisms of Pharmacological Action
- Anti-Infective Agents
- Antiviral Agents
- Enzyme Inhibitors
- Anti-HIV Agents
- Anti-Retroviral Agents
- Antimetabolites
- HIV Integrase Inhibitors
- Integrase Inhibitors
- Ribavirin
- Raltegravir Potassium
Other Study ID Numbers
- 2009-010005-36 (EudraCT Number)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on HIV Infections
-
University of MinnesotaWithdrawnHIV Infections | HIV/AIDS | Hiv | AIDS | Aids/Hiv Problem | AIDS and InfectionsUnited States
-
University of California, San DiegoUniversity of California, Los Angeles; University of Southern California; California... and other collaboratorsCompleted
-
Gérond'ifRecruiting
-
University of California, DavisCompleted
-
University of California, San DiegoNational Center for Complementary and Integrative Health (NCCIH)CompletedHIV PositiveUnited States
-
University of ChicagoUniversity of Athens; National Development and Research Institutes, Inc.Completed
-
HIV Prevention Trials NetworkNational Institute on Drug Abuse (NIDA); National Institute of Allergy and...CompletedHIV PositiveIndonesia, Ukraine, Vietnam
-
University of ZimbabweCompleted
-
Florida International UniversityCompleted
-
Boston Children's HospitalNational Institute on Minority Health and Health Disparities (NIMHD)Completed
Clinical Trials on Raltegravir
-
National Institute of Allergy and Infectious Diseases...Eunice Kennedy Shriver National Institute of Child Health and Human Development...CompletedHIV InfectionsUnited States, Puerto Rico, South Africa, Argentina, Brazil, Botswana
-
Massachusetts General HospitalMerck Sharp & Dohme LLCCompletedHIV | Neurotoxicity | HIV-associated Neurocognitive DisorderUnited States
-
ViiV HealthcareCompletedInfection, Human Immunodeficiency VirusUnited States
-
Merck Sharp & Dohme LLCCompleted
-
ViiV HealthcareGlaxoSmithKline; ShionogiCompletedHIV Infections | Infection, Human Immunodeficiency VirusUnited States, France, Netherlands, Spain, Taiwan, Australia, Belgium, Russian Federation, Canada, United Kingdom, Mexico, Italy, South Africa, Romania, Argentina, Hungary, Poland, Chile, Greece, Brazil
-
ANRS, Emerging Infectious DiseasesCompletedHIV-1 Infection | PREGNANCYFrance
-
ViiV HealthcareGlaxoSmithKline; ShionogiCompletedInfection, Human Immunodeficiency Virus IGermany, Spain, France, Australia, United States, Canada, United Kingdom, Italy, Russian Federation
-
IrsiCaixaCompleted