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

NCT00495677 | Completed Phase 2 Results

• 1 other identifier: A7691009
• Study Type: interventional
• Target: 43
• Locations: 1 country
• Sites: 2

Brief Summary

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

Conditions

HIV

Keywords

Treatment Experienced; Treatment Naive

Outcome Measures

Primary Outcomes (1)

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

  Baseline, Day 11

Secondary Outcomes (4)

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

  Day 1 up to Day 25

• Maximum Observed Plasma Concentration (Cmax)

  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

• Time to Reach Maximum Observed Plasma Concentration (Tmax)

  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

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

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

Other Outcomes (2)

• Number of Participants With Viral Tropism and Resistance

  Screening, pre-dose on Day 1; Day 11, 25

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

  Pre-dose on Day 1

Study Arms (6)

PF-00232798 40 mg

ACTIVE COMPARATOR

Drug: PF-00232798

PF-00232798 300 mg

ACTIVE COMPARATOR

Drug: PF-00232798

PF-00232798 400 mg

ACTIVE COMPARATOR

Drug: PF-00232798

PF-00232798 5 mg

ACTIVE COMPARATOR

Drug: PF-00232798

PF-00232798 20 mg

ACTIVE COMPARATOR

Drug: PF-00232798

PF-00232798 150 mg

ACTIVE COMPARATOR

Drug: PF-00232798

Interventions

PF-00232798 DRUG

Solution, 20 mg. once daily, 10 days

PF-00232798 20 mg

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Pfizer: lead

Study Sites (2)

Pfizer Investigational Site

Cologne, 50937, Germany

Location

Pfizer Investigational Site

Frankfurt am Main, 60590, Germany

Location

Related Links

• To obtain contact information for a study center near you, click here.

MeSH Terms

Interventions

PF 232798

Results Point of Contact

• Title: Pfizer ClinicalTrials.gov Call Center
• Organization: Pfizer, Inc.

ClinicalTrials.gov_Inquiries@pfizer.com

1-800-718-1021

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 29, 2007
• First Posted: July 3, 2007
• Study Start: June 1, 2007
• Primary Completion: September 1, 2008
• Study Completion: September 1, 2008
• Last Updated: October 30, 2013
• Results First Posted: October 30, 2013

Record last verified: 2013-08

Locations

DE (2)