HIV-1Phase 2NCT00348673

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

A Phase 2 study testing UK-453,061 in people with HIV-1, run by Pfizer at 3 sites in Germany.

Completed

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

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… Read more about this study

Who is it for?: Ages 18 to 55 years, men only
Conditions the study is for: HIV-1
What is being tested?: UK-453,061
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 49 participants
Where: 3 sitesGermany
Study dates: Feb 2006to Feb 2007
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 and patients aged 18-55 years inclusive.
Patients with virus not containing NNRTI resistant mutations as determined by the VircoGEN virtual phenotyping essay.

Who cannot join

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).

Trial locations and contacts

3 sites in 1 country.

Germany3 sites

Pfizer Investigational Site
Cologne, 50937
Pfizer Investigational Site
Frankfurt am Main, 60590
Pfizer Investigational Site
Hamburg, 20099

Other trials in Germany

About this study

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

Conditions: HIV-1
Being tested: UK-453,061

What participants receive

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

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

Study groups in NCT00348673
Study group	Role	What they receive
Stage 1	Experimental	Not described Receives: Drug: UK-453,061
Stage 2	Experimental	Not described Receives: Drug: UK-453,061

What is being measured

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

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.
Measured: Baseline, Day 8

Secondary outcomes (1)

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

Timeline

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

Feb 2006Feb 2007

First posted6 Jul 2006 (estimated)
Study startFeb 2006
Primary completionFeb 2007
Study completionFeb 2007

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 HIV-1Studies 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: Single group
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 49 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00348673
Sponsor's protocol ID: A5271010
Status last verified: Aug 2013
First submitted: 5 Jul 2006
Last updated: 18 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

RecruitingObservational study
Cohort of Women Living With HIV-1 and Receiving Bictegravir/Emtricitabine/Tenofovir Alafenamide
HIV (Human Immunodeficiency Virus), Pregnancy
RecruitingPhase 4
A Study to Provide Continued Access to Study Drug to Children and Adolescents Who Have Completed Clinical Studies Involving Gilead HIV Treatments
HIV-1-infection
RecruitingObservational study
Leukapheresis Procedures to Obtain Plasma and Lymphocytes for Research Studies on Antiretroviral Naive HIV-1 Research Participants
HIV
Active, not recruitingPhase 3
Study to Compare Bictegravir/Lenacapavir Versus Current Therapy in People With HIV-1 Who Are Successfully Treated With Biktarvy
HIV-1-infection
Active, not recruitingPhase 2/3
Study to Compare Bictegravir/Lenacapavir Versus Current Therapy in People With HIV-1 Who Are Successfully Treated With a Complicated Regimen (ARTISTRY-1)
HIV-1-infection

All HIV-1 trials

Study at a glance

From the registry record, last updated by the sponsor on 18 Oct 2013. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT00348673
Acronym / sponsor ID: A5271010
Conditions: HIV-1
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 49 participants (actual)
Lead sponsor: PfizerIndustry (pharma, biotech, devices)
Collaborators: ViiV Healthcare
Study start: Feb 2006
Primary completion: Feb 2007 (actual)
Study completion: Feb 2007 (actual)
First posted: 6 Jul 2006 (estimated)
Results: Posted 18 Oct 2013

Clinical summary

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

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Single group
Masking: Double blind (participant, investigator)
Number of arms: 2

Arm	Type	Receives
Stage 1	Experimental	Drug: UK-453,061
Stage 2	Experimental	Drug: UK-453,061

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

Key exclusion criteria (3 listed)

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).

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
UK-453,061Placebo BID, Placebo QD, UK-453,061 10 mg BID, 30 mg BID, 100 mg BID or 500 mg QD for 7 days	Drug	Stage 1
UK-453,061Placebo BID, Placebo QD, UK-453,061 100 mg QD, 500 mg BID or 750 mg QD for 7 days	Drug	Stage 2

Primary outcome

Change From Baseline in Human Immunodeficiency Virus-1 (HIV-1) Viral Load at Day 8
Time frame: Baseline, 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.

1 secondary outcome

Number of Participants With Time to Rebound of Human Immunodeficiency Virus (HIV) Viral Load
Time frame: Day 8 up to Follow-up (Day 38 to 40 [31 to 33 days post-last dose])

Results and safety

Results posted to the registry on 18 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
UK-453,061 10 mg Twice Daily (Stage 1)	6	6
UK-453,061 30 mg Twice Daily (Stage 1)	6	6
UK-453,061 100 mg Twice Daily (Stage 1)	7	6
UK-453,061 500 mg Once Daily (Stage 1)	6	6
Placebo Once/Twice Daily (Stage 1)	4	4
UK-453,061 750 mg Once Daily (Stage 2)	0	0
UK-453,061 500 mg Twice Daily (Stage 2)	0	0
UK-453,061 100 mg Once Daily (Stage 2)	0	0
Placebo Once/Twice Daily (Stage 2)	0	0

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

Time frame: Baseline, Day 8. Mean (Standard Deviation). Unit: log10 copies/mL

Measure	UK-453,061 10 mg Twice Daily (Stage 1) n = 6	UK-453,061 30 mg Twice Daily (Stage 1) n = 6	UK-453,061 100 mg Twice Daily (Stage 1) n = 6	UK-453,061 500 mg Once Daily (Stage 1) n = 6	UK-453,061 750 mg Once Daily (Stage 2) n = 6	UK-453,061 500 mg Twice Daily (Stage 2) n = 6	UK-453,061 100 mg Once Daily (Stage 2) n = 6	Placebo n = 6
Baseline	4.57 (0.33)	4.39 (0.48)	4.41 (0.27)	4.38 (0.17)	4.65 (0.46)	4.55 (0.45)	4.70 (0.33)	4.57 (0.49)
Change at Day 8	-0.30 (0.20)	-0.78 (0.45)	-1.33 (0.38)	-1.67 (0.19)	-1.79 (0.32)	-1.62 (0.22)	-0.92 (0.38)	0.01 (0.16)

Population analysed: Per protocol pharmacodynamic analysis set included all randomized participants who received at least 1 dose of study medication and had at least 1 post-dose viral load measurement.

1 secondary outcome is reported in the full results.

Adverse events

Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
UK-453,061 10 mg Twice Daily (Stage 1)	0 of 6 (0%)	3 of 6 (50%)	Not reported
UK-453,061 30 mg Twice Daily (Stage 1)	1 of 6 (16.7%)	5 of 6 (83.3%)	Not reported
UK-453,061 100 mg Twice Daily (Stage 1)	0 of 6 (0%)	5 of 6 (83.3%)	Not reported
UK-453,061 500 mg Once Daily (Stage 1)	0 of 6 (0%)	5 of 6 (83.3%)	Not reported
UK-453,061 750 mg Once Daily (Stage 2)	0 of 6 (0%)	6 of 6 (100%)	Not reported
UK-453,061 500 mg Twice Daily (Stage 2)	0 of 6 (0%)	6 of 6 (100%)	Not reported
UK-453,061 100 mg Once Daily (Stage 2)	0 of 6 (0%)	3 of 6 (50%)	Not reported
Placebo	0 of 6 (0%)	4 of 6 (66.7%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 18 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.

Related trials for HIV-1

RecruitingObservational study
Cohort of Women Living With HIV-1 and Receiving Bictegravir/Emtricitabine/Tenofovir Alafenamide
HIV (Human Immunodeficiency Virus), Pregnancy
RecruitingPhase 4
A Study to Provide Continued Access to Study Drug to Children and Adolescents Who Have Completed Clinical Studies Involving Gilead HIV Treatments
HIV-1-infection
RecruitingObservational study
Leukapheresis Procedures to Obtain Plasma and Lymphocytes for Research Studies on Antiretroviral Naive HIV-1 Research Participants
HIV
Active, not recruitingPhase 3
Study to Compare Bictegravir/Lenacapavir Versus Current Therapy in People With HIV-1 Who Are Successfully Treated With Biktarvy
HIV-1-infection
Active, not recruitingPhase 2/3
Study to Compare Bictegravir/Lenacapavir Versus Current Therapy in People With HIV-1 Who Are Successfully Treated With a Complicated Regimen (ARTISTRY-1)
HIV-1-infection

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

3 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 UK-453,061 in people with HIV-1, run by Pfizer at 3 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 3 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 18 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 3 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 18 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 Human Immunodeficiency Virus-1 (HIV-1) Viral Load at Day 8 (time frame: Baseline, Day 8). 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 NCT00348673.

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 18 Oct 2013.