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Completed

NCT Number: NCT00643643

Pharmacokinetics, Pharmacodynamics, And Safety Of Maraviroc (UK-427,857) In Patients With Human Immunodeficiency Virus

To investigate the relationship between the pharmacokinetics and pharmacodynamics of UK-427,857 and its antiviral effects in patients with human immunodeficiency virus (HIV).

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Key information

Conditions

HIV Infections Blood-Borne Infections Communicable Diseases Genital Diseases 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, Bonn, Germany

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

Inclusion criteria

  • Male with HIV or surgically sterilized female with HIV showing no symptoms of HIV
  • Weight between 50 and 90kg and within the permitted range for their height

Exclusion criteria

Exclusion criteria

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

Treatment and study plan

Maraviroc (UK-427,857)

Drug

25 mg oral tablet once daily for 10 days

Other names: Celsentri, Selzentry

Placebo

Other

Matching placebo oral tablet twice daily for 10 days

Other names: Celsentri, Selzentry

Primary outcomes

  1. Change from baseline in viral load

    Time frame: Day 11

  2. Pharmacokinetic profile of UK-427,857

    Time frame: Days 1 and 10

  3. Receptor saturation

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

Secondary outcomes

  1. 12-lead electrocardiography

    Time frame: Days 1-11 and Day 40

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

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

  3. Time to rebound of viral load

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

  4. The relationship of change in viral load (from baseline to day 11) versus average (Days 1-11) and trough (Day 10) plasma concentrations

    Time frame: Days 1-11

  5. The relationship of change in viral load (from baseline to day 11) versus mean receptor saturation (Day 10)

    Time frame: Days 1-11

  6. The relationship of change from baseline in viral load versus baseline virus susceptibility (IC 50 and IC 90)

    Time frame: Days 1-11

  7. Adverse events

    Time frame: Days 1-40

  8. Laboratory safety testing

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

  9. Physical examination

    Time frame: Days 1, 11, 40

  10. Supine and standing blood pressure and pulse rate

    Time frame: Days 1-11 and Day 40

Sponsors and collaborators

Lead sponsor

ViiV Healthcare

Industry

Collaborators

  • Pfizer

Registry information

Official study title

A Randomised, Double Blind, Placebo-Controlled, Multicentre Study Of UK-427,857 25mg O.D. , 50mg B.I.D., 100mg B.I.D And 300mg B.I.D. In Asymptomatic HIV Infected Patients To Investigate Pharmacodynamics, Pharmacokinetics, Safety And Toleration.

Important dates

Study start
2002
Primary completion
2003
Study completion
2003
First posted
Mar 26, 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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