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A Study Of Different Doses Of UK-453, 061 Plus Truvada Compared To Efavirenz Plus Truvada In Patients Who Have Not Been Previously Treated For HIV-1

Last updated on May 11, 2018

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Study Location
Pfizer Investigational Site
Buenos Aires, , C1405BCH Argentina
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
HIV-1
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18+ years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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.

Exclusion criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

- 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

NCT00824421
Pfizer
Completed
A Study Of Different Doses Of UK-453, 061 Plus Truvada Compared To Efavirenz Plus Truvada In Patients Who Have Not Been Previously Treated For HIV-1

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A Study Of Different Doses Of UK-453, 061 Plus Truvada Compared To Efavirenz Plus Truvada In Patients Who Have Not Been Previously Treated For HIV-1
A Phase 2B Multicenter, Randomized, Double-Blind, Comparative Trial Of UK-453,061, In Combination With Tenofovir Df And Emtricitabine Versus Efavirenz In Combination With Tenofovir DF And Emtricitabine For The Treatment Of Antiretroviral-Naive HIV-1 Infected Subjects
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.
Not Provided
Interventional
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
HIV-1
  • Drug: UK-453, 061
    UK-453,061 500 mg tablets PO QD + Tenofovir DF 300 mg/Emtricitabine 200 mg tablets PO QD.
  • Drug: UK-453, 061
    UK-453,061 750 mg tablets PO QD + Tenofovir DF 300 mg/Emtricitabine 200 mg tablets PO QD.
  • Drug: EFV +TVA
    Efavirenz 600 mg tablets PO QD + Tenofovir DF 300 mg/Emtricitabine 200 tablets mg PO QD.
  • Experimental: UK- 453,061 Dose One
    UK 453,061 Dose One plus Truvada
    Intervention: Drug: UK-453, 061
  • Experimental: UK-453,061 Dose Two
    UK 453,061 Dose Two plus Truvada
    Intervention: Drug: UK-453, 061
  • Active Comparator: Efavirenz + Truvada
    Efavirenz + Truvada
    Intervention: Drug: EFV +TVA
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
195
October 2011
October 2011   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Argentina,   Australia,   Canada,   Italy,   Mexico,   Poland,   South Africa,   Switzerland,   United Kingdom
 
 
NCT00824421
A5271015
Yes
Not Provided
Not Provided
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
November 2011

ICMJE     Data element required by the

International Committee of Medical Journal Editors
and the
World Health Organization ICTRP

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting thte study website. To get updates and notications about this trail, sign up using the form below.

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1-800-718-1021

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