A Study in Asymptomatic HIV Infected Patients to Investigate Pharmacodynamics, Pharmacokinetics, Safety and Toleration of UK-453,061
This study has been completed.
Sponsor:
Pfizer
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT00348673
First received: July 5, 2006
Last updated: May 14, 2013
Last verified: May 2013
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
HIV-1 |
Drug: UK-453,061 |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Pharmacodynamics Study Intervention Model: Single Group Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment |
| 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 |
Resource links provided by NLM:
Further study details as provided by Pfizer:
Primary Outcome Measures:
- Change in Human Immunodeficiency Virus-1 (HIV-1) viral load from baseline to Day 8 [ Time Frame: 8 days ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Time to Reach Maximum Observed Plasma Concentration (Tmax) [ Time Frame: 8 days ] [ Designated as safety issue: No ]
- Maximum Observed Plasma Concentration (Cmax) [ Time Frame: 8 days ] [ Designated as safety issue: No ]
- Area Under the Curve from Time Zero to end of dosing interval (AUCtau) [ Time Frame: 8 days ] [ Designated as safety issue: No ]
| Enrollment: | 49 |
| Study Start Date: | February 2006 |
| Study Completion Date: | February 2007 |
| Primary Completion Date: | February 2007 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: Stage 1 |
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
|
| Experimental: Stage 2 |
Drug: UK-453,061
Placebo BID, Placebo QD, UK-453,061 100 mg QD, 500 mg BID or 750 mg QD for 7 days
|
Eligibility| Ages Eligible for Study: | 18 Years to 55 Years |
| Genders Eligible for Study: | Male |
| Accepts Healthy Volunteers: | No |
Criteria
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).
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00348673
Locations
| Germany | |
| Pfizer Investigational Site | |
| Frankfurt am Main, Germany, 60590 | |
| Pfizer Investigational Site | |
| Hamburg, Germany, 20099 | |
| Pfizer Investigational Site | |
| Koeln, Germany, 50937 | |
Sponsors and Collaborators
Pfizer
Investigators
| Study Director: | Pfizer CT.gov Call Center | Pfizer |
More Information
Additional Information:
No publications provided
| Responsible Party: | Pfizer |
| ClinicalTrials.gov Identifier: | NCT00348673 History of Changes |
| Other Study ID Numbers: | A5271010 |
| Study First Received: | July 5, 2006 |
| Last Updated: | May 14, 2013 |
| Health Authority: | Germany: Ministry of Health |
ClinicalTrials.gov processed this record on June 13, 2013