HIVPhase 2NCT00495677

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

A Phase 2 study testing PF-00232798 in people with HIV, run by Pfizer at 2 sites in Germany.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

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

Who is it for?: Ages 18 to 55 years, men only
Conditions the study is for: HIV
What is being tested?: PF-00232798
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 43 participants
Where: 2 sitesGermany
Study dates: Jun 2007to Sep 2008
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 55 years
Men only
No healthy volunteers
Adult

Who may be able to join

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.

Who cannot join

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.

Trial locations and contacts

2 sites in 1 country.

Germany2 sites

Pfizer Investigational Site
Cologne, 50937
Pfizer Investigational Site
Frankfurt am Main, 60590

Other trials in Germany

About this study

Official title: A Randomised, Double-Blind, Placebo-Controlled, Multicentre Study In Asymptomatic Hiv-Infected Patients To Investigate The Pharmacodynamics, Pharmacokinetics, Safety And Toleration Of PF-00232798

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

Conditions: HIV
Being tested: PF-00232798
Keywords: Treatment Experienced, Treatment Naive

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

PF-00232798Drug
Solution, 20 mg. once daily, 10 days
PF-00232798Drug
Solution, 150 mg. once daily, 10 days
PF-00232798Drug
Solution, 5 mg. once daily, 10 days
PF-00232798Drug
Solution, 40 mg. once daily, 10 days
PF-00232798Drug
Solution, 300 mg. once daily, 10 days
PF-00232798Drug
Solution, 400 mg. once daily, 10 days

Study groups in NCT00495677
Study group	Role	What they receive
PF-00232798 40 mg	Active comparator	Not described Receives: Drug: PF-00232798
PF-00232798 300 mg	Active comparator	Not described Receives: Drug: PF-00232798
PF-00232798 400 mg	Active comparator	Not described Receives: Drug: PF-00232798
PF-00232798 5 mg	Active comparator	Not described Receives: Drug: PF-00232798
PF-00232798 20 mg	Active comparator	Not described Receives: Drug: PF-00232798
PF-00232798 150 mg	Active comparator	Not described Receives: Drug: PF-00232798

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: Baseline, Day 11

Secondary outcomes (4)

Number of Participants With Time to Rebound of Human Immunodeficiency Virus (HIV) Viral Load
The time to rebound of viral load was calculated as the time from the last dose to the time of the first occasion at which the viral load was greater than the baseline value. Results are reported for number of participants who rebound within specified days from last dose and who did not rebound up to Day 25.
Measured: Day 1 up to Day 25
Maximum Observed Plasma Concentration (Cmax)
Measured: 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)
Measured: 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)
AUCtau= Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to the time end of dosing interval (24 hours post-dose).
Measured: 0 hour (pre-dose), 1, 2, 3, 4, 6, 8, 12, 24 hours post-dose on Day 10

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jun 2007Sep 2008

First posted3 Jul 2007 (estimated)
Study startJun 2007
Primary completionSep 2008
Study completionSep 2008

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for HIVStudies of the same condition, open and under way.
More trials run by PfizerThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 43 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00495677
Sponsor's protocol ID: A7691009
Status last verified: Aug 2013
First submitted: 29 Jun 2007
Last updated: 30 Oct 2013
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All HIV trials

Study at a glance

From the registry record, last updated by the sponsor on 30 Oct 2013. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Randomised, Double-Blind, Placebo-Controlled, Multicentre Study In Asymptomatic Hiv-Infected Patients To Investigate The Pharmacodynamics, Pharmacokinetics, Safety And Toleration Of PF-00232798
ClinicalTrials.gov ID: NCT00495677
Acronym / sponsor ID: A7691009
Conditions: HIV
Keywords: Treatment Experienced, Treatment Naive
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 43 participants (actual)
Lead sponsor: PfizerIndustry (pharma, biotech, devices)
Study start: Jun 2007
Primary completion: Sep 2008 (actual)
Study completion: Sep 2008 (actual)
First posted: 3 Jul 2007 (estimated)
Results: Posted 30 Oct 2013

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 6

Arm	Type	Receives
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

Who may qualify

Ages: 18 to 55 years
Sex: Male only
Healthy volunteers: Not accepted
Age groups: Adult

Key inclusion criteria (2 listed)

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.

Key exclusion criteria (2 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
PF-00232798Solution, 20 mg. once daily, 10 days	Drug	PF-00232798 20 mg
PF-00232798Solution, 150 mg. once daily, 10 days	Drug	PF-00232798 150 mg
PF-00232798Solution, 5 mg. once daily, 10 days	Drug	PF-00232798 5 mg
PF-00232798Solution, 40 mg. once daily, 10 days	Drug	PF-00232798 40 mg
PF-00232798Solution, 300 mg. once daily, 10 days	Drug	PF-00232798 300 mg
PF-00232798Solution, 400 mg. once daily, 10 days	Drug	PF-00232798 400 mg

Primary outcome

Change From Baseline in Log 10-transformed Human Immunodeficiency Virus (HIV) Viral Load at Day 11
Time frame: Baseline, 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.

4 secondary outcomes

Number of Participants With Time to Rebound of Human Immunodeficiency Virus (HIV) Viral Load
Time frame: Day 1 up to Day 25
Maximum Observed Plasma Concentration (Cmax)
Time frame: 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)
Time frame: 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)
Time frame: 0 hour (pre-dose), 1, 2, 3, 4, 6, 8, 12, 24 hours post-dose on Day 10

Results and safety

Results posted to the registry on 30 Oct 2013, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Placebo	2	2
PF-00232798 5 mg	6	6
PF-00232798 20 mg	6	5
PF-00232798 150 mg	6	6
PF-00232798 40 mg	0	0
PF-00232798 300 mg	0	0
PF-00232798 400 mg	0	0

Primary outcome: Change From Baseline in Log 10-transformed Human Immunodeficiency Virus (HIV) Viral Load at Day 11

Time frame: Baseline, Day 11. Mean (Standard Deviation). Unit: log10 copies/mL

Measure	PF-00232798 5 mg n = 6	PF-00232798 20 mg n = 5	PF-00232798 40 mg n = 8	PF-00232798 150 mg n = 6	PF-00232798 300 mg n = 8	PF-00232798 400 mg n = 7	Placebo n = 2
Baseline	4.692 (0.3075)	4.338 (0.4753)	4.306 (0.8241)	4.483 (0.4322)	4.315 (0.6120)	4.715 (0.3153)	4.482 (0.9800)
Change at Day 11	-0.253 (0.3308)	-0.687 (0.4260)	-0.916 (0.4267)	-1.325 (0.3887)	-1.546 (0.3028)	-1.492 (0.5103)	-0.135 (0.0089)

Population analysed: Pharmacodynamic population included all participants who were randomized, treated and had at least 1 post-dose HIV viral load measurement in the study.

4 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
PF-00232798 5 mg	0 of 6 (0%)	2 of 6 (33.3%)	Not reported
PF-00232798 20 mg	1 of 6 (16.7%)	6 of 6 (100%)	Not reported
PF-00232798 40 mg	0 of 8 (0%)	7 of 8 (87.5%)	Not reported
PF-00232798 150 mg	0 of 6 (0%)	5 of 6 (83.3%)	Not reported
PF-00232798 300 mg	0 of 8 (0%)	6 of 8 (75%)	Not reported
PF-00232798 400mg	1 of 7 (14.3%)	3 of 7 (42.9%)	Not reported
Placebo	0 of 2 (0%)	2 of 2 (100%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 30 Oct 2013.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
To obtain contact information for a study center near you, click here.Link provided by the sponsor.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Pfizer CT.gov Call Center study director

Pfizer

2 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing PF-00232798 in people with HIV, run by Pfizer at 2 sites in Germany.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 30 Oct 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 30 Oct 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change From Baseline in Log 10-transformed Human Immunodeficiency Virus (HIV) Viral Load at Day 11 (time frame: Baseline, Day 11). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00495677.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Oct 2013.