NCT00824421

Brief Summary

This is a 96 week study to determine if UK- 453,061 in combination with Truvada is as efficacious, safe and tolerable as efavirenz in combination with Truvada in HIV-1 infected patients who have not been previously treated with antiretroviral drugs.

Trial Health

93
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
195

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Feb 2009

Geographic Reach
9 countries

31 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 15, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 16, 2009

Completed
16 days until next milestone

Study Start

First participant enrolled

February 1, 2009

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2011

Completed
2.3 years until next milestone

Results Posted

Study results publicly available

January 24, 2014

Completed
Last Updated

January 24, 2014

Status Verified

November 1, 2011

Enrollment Period

2.7 years

First QC Date

January 15, 2009

Results QC Date

December 9, 2013

Last Update Submit

December 9, 2013

Conditions

HIV-1

Keywords

HIV-1. Treatment NaiveHIV Infectionstreatment naive

Outcome Measures

Primary Outcomes (1)

  • Percentage of Participants With Less Than 50 Copies Per Milliliter (Copies/mL) of Human Immunodeficiency Virus Type 1 Ribonucleic Acid (HIV-1 RNA) at Week 48

    Plasma HIV-1 RNA level was determined by validated Roche Amplicor HIV-1 Monitor standard assay.

    Week 48

Secondary Outcomes (15)

  • Percentage of Participants With Less Than 50 Copies/mL of HIV-1 RNA at Week 24 and 96

    Week 24, 96

  • Percentage of Participants With Less Than 400 Copies/mL of HIV-1 RNA at Week 24, 48 and 96

    Week 24, 48, 96

  • Change From Baseline in Log 10 Transformed HIV-1 RNA Levels at Week 24, 48 and 96

    Baseline, Week 24, 48, 96

  • Time-Averaged Difference (TAD) in Log 10 Transformed HIV-1 RNA Levels at Week 24, 48 and 96

    Baseline up to Week 24, 48, 96

  • Percentage of Participants With Response as Determined Using the Time-to Loss of Virologic Response (TLOVR50) Algorithm at Week 24, 48 and 96

    Week 24, 48, 96

  • +10 more secondary outcomes

Study Arms (3)

UK- 453,061 Dose One

EXPERIMENTAL

UK 453,061 Dose One plus Truvada

Drug: UK-453, 061

UK-453,061 Dose Two

EXPERIMENTAL

UK 453,061 Dose Two plus Truvada

Drug: UK-453, 061

Efavirenz + Truvada

ACTIVE COMPARATOR

Efavirenz + Truvada

Drug: EFV +TVA

Interventions

UK-453, 061DRUG

UK-453,061 500 mg tablets PO QD + Tenofovir DF 300 mg/Emtricitabine 200 mg tablets PO QD.

UK- 453,061 Dose One
EFV +TVADRUG

Efavirenz 600 mg tablets PO QD + Tenofovir DF 300 mg/Emtricitabine 200 tablets mg PO QD.

Efavirenz + Truvada

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Male or female at least 18 years of age available for a follow-up period of at least 96 weeks.
  • HIV 1 RNA viral load of greater then 1,000 copies/mL
  • Negative urine pregnancy test.

You may not qualify if:

  • Suspected or documented active, untreated HIV-1 related opportunist infection or other condition requiring acute therapy at the time of randomization.
  • Subjects with acute Hepatitis B and/or C within 30 days of randomization.
  • Absolute CD4 count \<200 cells/mm3.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (31)

Pfizer Investigational Site

Buenos Aires, C1405BCH, Argentina

Location

Pfizer Investigational Site

Darlinghurst, New South Wales, 2010, Australia

Location

Pfizer Investigational Site

Melbourne, Victoria, 3004, Australia

Location

Pfizer Investigational Site

Toronto, Ontario, M5B 1L6, Canada

Location

Pfizer Investigational Site

Montreal, Quebec, H2L 4P9, Canada

Location

Pfizer Investigational Site

Montreal, Quebec, H2L 5B1, Canada

Location

Pfizer Investigational Site

Milan, 20127, Italy

Location

Pfizer Investigational Site

Milan, 20142, Italy

Location

Pfizer Investigational Site

Torino, 10149, Italy

Location

Pfizer Investigational Site

Mexico City, Mexico City, 14050, Mexico

Location

Pfizer Investigational Site

Bydgoszcz, 85-030, Poland

Location

Pfizer Investigational Site

Gdansk, 80-214, Poland

Location

Pfizer Investigational Site

Lodz, 91-347, Poland

Location

Pfizer Investigational Site

Warsaw, 01-201, Poland

Location

Pfizer Investigational Site

Johannesburg, Gauteng, 2193, South Africa

Location

Pfizer Investigational Site

Pretoria, Gauteng, 0083, South Africa

Location

Pfizer Investigational Site

Soweto, Gauteng, 2013, South Africa

Location

Pfizer Investigational Site

Durban, KwaZulu-Natal, 4001, South Africa

Location

Pfizer Investigational Site

Namakgale, Limpopo, 1391, South Africa

Location

Pfizer Investigational Site

Cape Town, Western Cape, 7925, South Africa

Location

Pfizer Investigational Site

Pretoria, 0083, South Africa

Location

Pfizer Investigational Site

Ch-8091 Zurich, Switzerland

Location

Pfizer Investigational Site

Lugano, 6903, Switzerland

Location

Pfizer Investigational Site

Sankt Gallen, 9007, Switzerland

Location

Pfizer Investigational Site

Crumpsall, Greater Manchester, M8 5RB, United Kingdom

Location

Pfizer Investigational Site

Brighton, BN2 1ES, United Kingdom

Location

Pfizer Investigational Site

Edinburgh, EH3 9HA, United Kingdom

Location

Pfizer Investigational Site

Edinburgh, EH4 2XU, United Kingdom

Location

Pfizer Investigational Site

London, NW3 2QG, United Kingdom

Location

Pfizer Investigational Site

London, SW10 9NH, United Kingdom

Location

Pfizer Investigational Site

London, W2 1NY, United Kingdom

Location

Related Links

MeSH Terms

Conditions

HIV Infections

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System Diseases

Results Point of Contact

Title
Pfizer ClinicalTrials.gov Call Center
Organization
Pfizer, Inc.
ClinicalTrials.gov_Inquiries@pfizer.com
1-800-718-1021

Study Officials

  • Pfizer CT.gov Call Center

    Pfizer

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 15, 2009

First Posted

January 16, 2009

Study Start

February 1, 2009

Primary Completion

October 1, 2011

Study Completion

October 1, 2011

Last Updated

January 24, 2014

Results First Posted

January 24, 2014

Record last verified: 2011-11

Locations

CA(3)AR(1)IT(3)CH(3)ME(1)PL(4)ZA(7)GB(7)AU(2)