ICTRP Search Portal

Main

Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.

Register:	EUCTR
Last refreshed on:	19 March 2012
Main ID:	EUCTR2006-006821-15-DE
Date of registration:	07/03/2007
Prospective Registration:	Yes
Primary sponsor:	Pfizer Inc., 235 East 42nd Street, New York, NY 10017
Public title:	A RANDOMISED, DOUBLE-BLIND (SPONSOR-OPEN), PLACEBO-CONTROLLED, MULTICENTRE STUDY IN ASYMPTOMATIC HIV-INFECTED PATIENTS TO INVESTIGATE THE PHARMACODYNAMICS, PHARMACOKINETICS, SAFETY AND TOLERATION OF PF-00232798 - N/A
Scientific title:	A RANDOMISED, DOUBLE-BLIND (SPONSOR-OPEN), PLACEBO-CONTROLLED, MULTICENTRE STUDY IN ASYMPTOMATIC HIV-INFECTED PATIENTS TO INVESTIGATE THE PHARMACODYNAMICS, PHARMACOKINETICS, SAFETY AND TOLERATION OF PF-00232798 - N/A
Date of first enrolment:	21/06/2007
Target sample size:	44
Recruitment status:	Not Recruiting
URL:	https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2006-006821-15
Study type:	Interventional clinical trial of medicinal product
Study design:	Controlled: yes Randomised: yes Open: no Single blind: no Double blind: yes Parallel group: yes Cross over: no Other: yes Other trial design description: Sponsor Open If controlled, specify comparator, Other Medicinial Product: no Placebo: yes Other: no
Phase:

Countries of recruitment
Germany

Contacts

Name:
Address:
Telephone:
Email:
Affiliation:

Name:
Address:
Telephone:
Email:
Affiliation:

Key inclusion & exclusion criteria

Inclusion criteria:
Subjects must meet all of the following inclusion criteria to be eligible for enrollment into the study:
1. Asymptomatic HIV-1 infected male patients between the ages of 18-55 years inclusive.
2. Weight between 50 and 100 kg and within the permitted range for their height using Quetelet's index-weight (kg)/height (m2). The permitted index is between 18-30.
3. Patients with CCR5 tropic virus as determined by the Monogram PhenoSense Entry
assay.
4. Willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion criteria:
Subjects presenting with any of the following will not be included in the study:
1. Patients who on direct questioning or physical examination have evidence of any
clinically significant disease that in the opinion of the investigator may impact on their
participation in the study.
2. Patients with a CD4 count <250 cells/mm3.
3. Patients whose HIV infection has been diagnosed <3 months prior to screening, or for whom there is evidence of recent seroconversion.
4. Patients with an HIV viral load <5000 copies/mL using the Roche COBAS Taqman HIV 1 assay.
5. Patients with CXCR4 or dual tropic virus as determined by the Monogram recombinant virus entry assay or repeated assay failure.
6. Patients with AIDS or a previous AIDS diagnosis.
7. Patients who are taking, or have taken, antiretroviral drugs in the eight weeks prior to the study screening visit.
8. Any patient, who in the opinion of the investigator, may need treatment with
antiretroviral drugs before the end of the study period.
9. Patients with any clinically significant abnormality following review of pre-study
laboratory data and full physical examination apart from that which would be expected as part of HIV infection. Specifically patients with evidence of hepatic impairment (cut-off values of AST, ALT and AP >2.5 ULN, total bilirubin >1.5 ULN and albumin 10. Patients who are taking, or have taken, any prescribed or over the counter (with the exception of paracetamol (up to 3 g per day), multivitamins and minerals) drugs in the three weeks prior to the first dose of study medication, except those approved by the Pfizer Clinician.
11. Patients with a history of severe drug hypersensitivity reactions.
12. Patients who drink more than 21 units of alcohol per week (1 unit = 150 mL wine,
360 mL beer or 45 mL of spirits).
13. Patients who have a psychological or sociological condition or an addictive disorder that would preclude compliance with the protocol in the opinion of the investigator.
14. 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.
15. Current or past history of QT prolongation or abnormality on ECG, or 12-lead ECG demonstrating QTc>450 msec at screening.

Age minimum:
Age maximum:
Gender:
Female: no
Male: yes

Health Condition(s) or Problem(s) studied

Human Immunodeficiency Virus (HIV) infection
MedDRA version: 9.1 Level: LLT Classification code 10000807 Term: Acute HIV infection

Intervention(s)

Product Code: PF-00232798
Pharmaceutical Form: Powder for oral solution
INN or Proposed INN: N/A
CAS Number: 849753-20-4
Current Sponsor code: PF-00232798
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 5 -
Pharmaceutical form of the placebo: Powder for oral solution
Route of administration of the placebo: Oral use

Product Code: PF-00232798
Pharmaceutical Form: Powder for oral solution
INN or Proposed INN: N/A
CAS Number: 849753-20-4
Current Sponsor code: PF-00232798
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 20-
Pharmaceutical form of the placebo: Powder for oral solution
Route of administration of the placebo: Oral use

Product Code: PF-00232798
Pharmaceutical Form: Powder for oral solution
INN or Proposed INN: N/A
CAS Number: 849753-20-4
Current Sponsor code: PF-00232798
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 150-
Pharmaceutical form of the placebo: Powder for oral solution
Route of administration of the placebo: Oral use

Product Code: PF-00232798
Pharmaceutical Form: Powder for oral solution
INN or Proposed INN: N/A
CAS Number: 849753-20-4
Current Sponsor code: PF-00232798
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 40-

Product Code: PF-00232798
Pharmaceutical Form: Powder for oral solution
INN or Proposed INN: N/A
CAS Number: 849753-20-4
Current Sponsor code: PF-00232798
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 300-

Product Code: PF-00232798
Pharmaceutical Form: Powder for oral solution
INN or Proposed INN: N/A
CAS Number: 849753-20-4
Current Sponsor code: PF-00232798
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 400-

Primary Outcome(s)

Primary end point(s): HIV viral load

Secondary Objective:

Main Objective: - Investigate the effects of 10-day monotherapy of PF-00232798 on viral load response in asymptomatic HIV-infected patients and to the assess dose-response relationship.
- Assess the pharmacokinetics, safety and tolerability of PF-00232798 in HIV-infected patients.

Secondary Outcome(s)

Secondary ID(s)

N/A

A7691009

Source(s) of Monetary Support

Secondary Sponsor(s)

Ethics review

Results

Results available:
Date Posted:
Date Completed:
URL:

Disclaimer: Trials posted on this search portal are not endorsed by WHO, but are provided as a service to our users. In no event shall the World Health Organization be liable for any damages arising from the use of the information linked to in this section. None of the information obtained through use of the search portal should in any way be used in clinical care without consulting a physician or licensed health professional. WHO is not responsible for the accuracy, completeness and/or use made of the content displayed for any trial record.