NCT00348673

Brief Summary

A phase 2a study to investigate the effects of 7-day monotherapy of UK-453,061 on viral load response in asymptomatic human immunodeficiency virus (HIV) infected subjects, to assess the dose-response relationship, and to assess the pharmacokinetics (PK), safety and tolerability of UK-453,061 in asymptomatic HIV infected subjects.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
49

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Feb 2006

Shorter than P25 for phase_2

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2006

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

July 5, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 6, 2006

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2007

Completed
6.7 years until next milestone

Results Posted

Study results publicly available

October 18, 2013

Completed
Last Updated

October 18, 2013

Status Verified

August 1, 2013

Enrollment Period

1 year

First QC Date

July 5, 2006

Results QC Date

August 14, 2013

Last Update Submit

August 14, 2013

Conditions

HIV-1

Outcome Measures

Primary Outcomes (1)

  • Change From Baseline in Human Immunodeficiency Virus-1 (HIV-1) Viral Load at Day 8

    Change from baseline in log 10-transformed plasma viral load(Human Immunodeficiency Virus-1 Ribonucleic Acid\[HIV-1 RNA\]) levels(log10 copies/milliliter\[copies/mL\])reported.Viral load determined using reverse transcriptase-polymerase chain reaction(RT-PCR) assay with standard lower limit of detection(LLOD) 400 copies/mL.For samples with reading less than (\<)400 copies/mL,assay repeated using ultra sensitive method with LLOD of 50 copies/mL.Values below limit of quantification(LOQ) 50 copies/mL set to 50 copies/mL.Baseline was mean of three pre-dose values taken at screening,randomization,Day 1.

    Baseline, Day 8

Secondary Outcomes (1)

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

    Day 8 up to Follow-up (Day 38 to 40 [31 to 33 days post-last dose])

Other Outcomes (3)

  • Area Under the Curve From Time Zero to End of Dosing Interval at Steady State (AUCtau,ss)

    0 (pre-dose), 1, 2, 3, 4, 6, 12 hours post-dose; additional 24 hours post-dose for once daily regimen on Day 8

  • Maximum Observed Plasma Concentration at Steady State (Cmax,ss)

    0 (pre-dose), 1, 2, 3, 4, 6, 12 hours post-dose; additional 24 hours post-dose for once daily regimen on Day 8

  • Time to Reach Maximum Observed Plasma Concentration at Steady State (Tmax,ss)

    0 (pre-dose), 1, 2, 3, 4, 6, 12 hours post-dose; additional 24 hours post-dose for once daily regimen on Day 8

Study Arms (2)

Stage 1

EXPERIMENTAL
Drug: UK-453,061

Stage 2

EXPERIMENTAL
Drug: UK-453,061

Interventions

UK-453,061DRUG

Placebo BID, Placebo QD, UK-453,061 10 mg BID, 30 mg BID, 100 mg BID or 500 mg QD for 7 days

Stage 1

Eligibility Criteria

Age18 Years - 55 Years
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Asymptomatic HIV-1 infected male and patients aged 18-55 years inclusive.
  • Patients with virus not containing NNRTI resistant mutations as determined by the VircoGEN virtual phenotyping essay.

You may not qualify if:

  • Patients with a CD4 count less than 250 cells/mm3.
  • Patients whose HIV infection has been diagnosed less than 3 months prior to screening, or for whom there is evidence of recent seroconversion.
  • Patients with an HIV viral load less than 5000 copies/ml using RT-PCR(Roche Amplicor v1.5).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Pfizer Investigational Site

Cologne, 50937, Germany

Location

Pfizer Investigational Site

Frankfurt am Main, 60590, Germany

Location

Pfizer Investigational Site

Hamburg, 20099, Germany

Location

Related Links

MeSH Terms

Interventions

UK 453,061

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
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 5, 2006

First Posted

July 6, 2006

Study Start

February 1, 2006

Primary Completion

February 1, 2007

Study Completion

February 1, 2007

Last Updated

October 18, 2013

Results First Posted

October 18, 2013

Record last verified: 2013-08

Locations

DE(3)