A Study in Asymptomatic HIV Infected Patients to Investigate Pharmacodynamics, Pharmacokinetics, Safety and Toleration of UK-453,061

HIV-1 Clinical Trial

Official title:

A Randomised, Double Blind, Placebo-controlled, Multicenter Study in Asymptomatic HIV Infected Patients to Investigate Pharmacodynamics, Pharmacokinetics, Safety and Toleration of UK-453,061

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00348673
• Other study ID #: A5271010
• Status: Completed
• Phase: Phase 2
• First received: July 5, 2006
• Last updated: August 14, 2013
• Start date: February 2006
• Est. completion date: February 2007

Study information

• Verified date: August 2013
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 49
• Est. completion date: February 2007
• Est. primary completion date: February 2007
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years to 55 Years

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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).

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• HIV-1

Intervention

Drug:
• UK-453,061
Placebo BID, Placebo QD, UK-453,061 10 mg BID, 30 mg BID, 100 mg BID or 500 mg QD for 7 days
• UK-453,061
Placebo BID, Placebo QD, UK-453,061 100 mg QD, 500 mg BID or 750 mg QD for 7 days

Locations

Country	Name	City	State
Germany	Pfizer Investigational Site	Frankfurt am Main
Germany	Pfizer Investigational Site	Hamburg
Germany	Pfizer Investigational Site	Koeln

Sponsors (2)

Lead Sponsor	Collaborator
Pfizer	ViiV Healthcare

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Area Under the Curve From Time Zero to End of Dosing Interval at Steady State (AUCtau,ss)	AUCtau = Area under the plasma concentration versus time curve from time zero (pre-dose) to the end of the dosing interval (tau), the dosing interval was 12 hours for twice daily regimen and 24 hours for once daily regimen.	0 (pre-dose), 1, 2, 3, 4, 6, 12 hours post-dose; additional 24 hours post-dose for once daily regimen on Day 8	No
Other	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	No
Other	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	No
Primary	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	No
Secondary	Number of Participants With Time to Rebound of Human Immunodeficiency Virus (HIV) Viral Load	Time to rebound of viral load was defined as time from the last dose (Day 8) to the time of the first occasion at which the viral load was greater than baseline value. Number of participants with rebound of viral load at specified number of days after last dose (day 8) was reported.	Day 8 up to Follow-up (Day 38 to 40 [31 to 33 days post-last dose])	No

External Links

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