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Completed

NCT Number: NCT00495677

A Phase 2 Study Of PF-00232798 In HIV Positive Patients

To assess the viral load response, safety, tolerability and pharmacokinetics of multiple oral doses of PF 00232798 in HIV-positive patient volunteers.

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Key information

Conditions

HIV

Age range

18 year–55 year

Sex eligibility

Male

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 patients between the ages of 18 and 55 years inclusive.
  • Patients with CCR5 tropic virus as determined by the Monogram PhenoSense Entry assay.

Exclusion criteria

  • Patients who have received any experimental drug within the past four months (prior to the first dosing day of the study) or who have previously received another CCR5 antagonist.
  • Patients with evidence of decompensated liver disease.

Treatment and study plan

PF-00232798

Drug

Solution, 20 mg. once daily, 10 days

Primary outcomes

  1. Change From Baseline in Log 10-transformed Human Immunodeficiency Virus (HIV) Viral Load at Day 11

    Time frame: Baseline, Day 11

    Viral load was determined using the Roche COBAS Taqman HIV-1 assay with a lower limit of detection of 40 copies per milliliter (copies/mL). Samples with an initial reading of less than 1,000,000 copies/mL were diluted into range and re-assayed.

Secondary outcomes

  1. Number of Participants With Time to Rebound of Human Immunodeficiency Virus (HIV) Viral Load

    Time frame: Day 1 up to Day 25

    The time to rebound of viral load was calculated as the time from the last dose to the time of the first occasion at which the viral load was greater than the baseline value. Results are reported for number of participants who rebound within specified days from last dose and who did not rebound up to Day 25.

  2. Maximum Observed Plasma Concentration (Cmax)

    Time frame: 0 hour (pre-dose) on Day 1 to 9; 0 hour (pre-dose), 1, 2, 3, 4, 6, 8, 12, 24 hours post-dose on Day 10; Day 12, 13, 15 morning

  3. Time to Reach Maximum Observed Plasma Concentration (Tmax)

    Time frame: 0 hour (pre-dose) on Day 1 to 9; 0 hour (pre-dose), 1, 2, 3, 4, 6, 8, 12, 24 hours post-dose on Day 10; Day 12, 13, 15 morning

  4. Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau)

    Time frame: 0 hour (pre-dose), 1, 2, 3, 4, 6, 8, 12, 24 hours post-dose on Day 10

    AUCtau= Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to the time end of dosing interval (24 hours post-dose).

Other outcomes

  1. Number of Participants With Viral Tropism and Resistance

    Time frame: Screening, pre-dose on Day 1; Day 11, 25

    Virus tropism was determined using the Monogram PhenoSense Entry assay; standard Trofile tropisim assay was used for Stage 1 and enhanced sensitivity Trofile tropisim assay was used for Stage 2.

  2. Number of Participants With Chemokine Receptor 5 (CCR5) Delta 32 Genotyping and Immunophenotyping

    Time frame: Pre-dose on Day 1

    CCR5 Delta 32 genotyping and immunophenotyping was to be done to assess CCR5 Delta 32 status, other CCR5 polymorphisms, enzymes involved in drug metabolism and/or drug transport proteins in order to measure the impact of genetic variation with respect to PF-00232798 in case any unusual patterns of response or an unexplained excess of adverse events occurred.

Sponsors and collaborators

Lead sponsor

Pfizer

Industry

Registry information

Official study title

A Randomised, Double-Blind, Placebo-Controlled, Multicentre Study In Asymptomatic Hiv-Infected Patients To Investigate The Pharmacodynamics, Pharmacokinetics, Safety And Toleration Of PF-00232798

Important dates

Study start
2007
Primary completion
2008
Study completion
2008
First posted
Jul 3, 2007
Registry last updated
Oct 30, 2013

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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