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Completed

NCT Number: NCT00634959

Effects Of Food And Dose Regimen On The Antiviral Effects Of Maraviroc (UK-427,857) In Patients With Human Immunodeficiency Virus

To investigate the effects of food and dose regimen on the antiviral effects of Maraviroc (UK-427,857) in patients with human immunodeficiency virus (HIV)

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Key information

Conditions

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

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Pfizer Investigational Site, Cologne, Germany

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Asymptomatic HIV-1 infected male and female patients
  • Weight between 50 and 100kg and within the permitted range for their height
  • Patients with virus that targets CCR5 receptor

Exclusion criteria

  • Patients with a CD4 count <250 cells/mm3 or HIV viral load <5000 copies/mL
  • Patients whose HIV infection has been diagnosed less than 3 months prior to screening, or for who there is evidence of recent seroconversion
  • Patients with acquired immunodeficiency syndrome (AIDS) or a previous AIDS diagnosis
  • Patients who are taking or have taken antiretroviral drugs in the eight weeks prior to the study screening visit

Treatment and study plan

Maraviroc (UK-427,857)

Drug

150 mg oral tablet twice daily while fasted on Days 1-9 and on Day 10 (morning dose only)

Other names: Celsentri, Selzentry

Placebo

Other

Matching placebo oral tablet on Days 1-10 (fed and fasted)

Primary outcomes

  1. Change from baseline in viral load

    Time frame: Day 11

  2. UK-427,857 pharmacokinetics

    Time frame: Days 1-11

Secondary outcomes

  1. Physical examination

    Time frame: Days 1, 11, 40

  2. 12-lead ECG

    Time frame: Days 1-11 and Day 40

  3. Relationship of change in viral load (baseline to Day 11) versus mean receptor saturation (Day 10)

    Time frame: Days 1-11

  4. Time course of viral load from baseline to follow-up

    Time frame: Days 1-13 and Days 15, 19, 22, 25, 40

  5. CCR5 receptor saturation

    Time frame: Days 1, 5, 10, 11, 13, 15, 19, 40

  6. Adverse events

    Time frame: Days 1-40

  7. Relationship of change in viral load (baseline to Day 11) versus baseline susceptibility (IC50 and IC90)

    Time frame: Days 1-11

  8. Laboratory safety

    Time frame: Days 1, 3, 7, 11, 15, 40

  9. Relationship of change in viral load (baseline to Day 11) versus average and trough plasma concentrations (Day 10)

    Time frame: Days 1-11

  10. Supine/standing blood pressure and pulse rate

    Time frame: Days 1-11 and Day 40

  11. Time to rebound of viral load

    Time frame: Days 1-13 and Days 15, 19, 22, 25, 40

Sponsors and collaborators

Lead sponsor

ViiV Healthcare

Industry

Collaborators

  • Pfizer

Registry information

Official study title

An Investigation Into The Effects Of Food And Dose Regimen On Viral Load Response In HIV Infected Patients On Short-Term Monotherapy With UK-427,857 (Maraviroc)

Important dates

Study start
2003
Study completion
2003
First posted
Mar 13, 2008
Registry last updated
Nov 10, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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