Trial of Maraviroc (UK-427,857) in Combination With Zidovudine/Lamivudine Versus Efavirenz in Combination With Zidovudine/Lamivudine

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NCT00098293

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Study Location
Pfizer Investigational Site
Birmingham, Alabama, 35233, United States
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Contact
1-800-718-1021
[email protected]
Related Links

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting the study website. Please see the references below:

By phone

Pfizer Clinical Trials Contact Center

1-800-718-1021

By email

Contact

[email protected]

Call Now

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
16 + years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Men or women at least 16 years of age (or minimum age as determined by local regulatory authorities)

- HIV-1 RNA viral load of greater than or equal to 2, 000 copies/mL

- A negative urine pregnancy test at the baseline visit for Women of Child Bearing Potential (WOCBP)

- Effective barrier contraception for WOCBP and males

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 opportunistic infection (OI)
or other condition requiring acute therapy


- Treatment for an active opportunistic infection, or unexplained temperature >38.5
degrees Celsius for 7 consecutive days


- Prior treatment with efavirenz, zidovudine or lamivudine or with any other
antiretroviral therapy for more than 14 days at any time


- Active alcohol or substance abuse sufficient, in the Investigator's judgment, to
prevent adherence to study medication and/or follow up


- Lactating women, or planned pregnancy during the trial period


- Suspected primary (acute) HIV-1 infection


- Previous therapy with a potentially myelosuppressive, neurotoxic, hepatotoxic and/or
cytotoxic agent within 30 days prior to randomization or the expected need for such
therapy during the study period


- Documented or suspected acute hepatitis or pancreatitis within 30 days prior to
randomization


- Significantly elevated liver enzymes or cirrhosis


- Significant neutropenia, anemia or thrombocytopenia


- Malabsorption or an inability to tolerate oral medications


- Symptomatic postural hypotension or severe cardiovascular or cerebrovascular disease


- Certain medications


- Genotypic or phenotypic resistance to efavirenz, zidovudine or lamivudine


- X4- or dual/mixed-tropic virus or repeated assay failure


- Any other clinical condition that, in the Investigator's judgement, would potentially
compromise study compliance or the ability to evaluate safety/efficacy

NEED INFO?

Questions about a trial? Call or email to reach a Pfizer Clinical Trial Contact Center Representative

Pfizer Clinical Trials Contact Center

1-800-718-1021

[email protected]

Call Now
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NCT00098293
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Advanced Information
Descriptive Information
Brief Title  ICMJE Trial of Maraviroc (UK-427,857) in Combination With Zidovudine/Lamivudine Versus Efavirenz in Combination With Zidovudine/Lamivudine
Official Title  ICMJE A Multicenter, Randomized, Double-Blind, Comparative Trial Of A Novel CCR5 Antagonist, UK-427,857, In Combination With Zidovudine/Lamivudine Versus Efavirenz In Combination With Zidovudine/Lamivudine For The Treatment Of Antiretroviral-Naive HIV-1 Infected Subjects
Brief Summary Maraviroc (UK-427,857), a selective and reversible CCR5 coreceptor antagonist, has been shown to be active in vitro against a wide range of clinical isolates (including those resistant to existing classes). In HIV-1 infected patients, maraviroc (UK-427,857) given as monotherapy for 10 days reduced HIV-1 viral load by up to 1.6 log, consistent with currently available agents. Safety and toleration have been studied in over 400 subjects for up to 28 days at 300 mg twice daily. No significant effects were seen on the QTc interval. The goal of this study is to compare the safety and efficacy of maraviroc (UK-427,857) versus efavirenz, when each are combined with two other antiretroviral agents, in patients who are previously naive to antiretroviral therapy. This study will involve approximately 200 centers from around the world to achieve a total randomized subject population of 1071 subjects. Patients will be randomly assigned to one of three groups: maraviroc (UK-427,857) 300 mg once daily added to zidovudine/lamivudine (300 mg/150 mg twice daily), Maraviroc (UK-427,857) 300 mg twice daily added to zidovudine/lamivudine (300 mg/150 mg twice daily) or efavirenz (600 mg once daily) added to zidovudine/lamivudine (300 mg/150 mg twice daily). The study will enroll over approximately an 18 month period (5 months Phase 2b run-in, 13 months Phase 3) with 96 weeks of treatment. This may be extended for an additional 3 years depending on the results at 96 weeks. Physical examinations will be performed at study entry, weeks 4, 8, 12, 16, 20, 24, 32, 40, 48, 60, 72, 84 and 96. Blood samples will also be taken at study entry, weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, 60, 72, 84 and 96. Additionally, blood samples will be drawn twice, at least 30 minutes apart, at weeks 2 and 48 for maraviroc (UK-427,857) pharmacokinetic analysis. As part of this clinical study a blood sample will be taken for non-anonymized pharmacogenetic analysis. Patients will undergo a 12-lead electrocardiogram at study entry, weeks 24, 48 and 96. A computerized tomography (CT) scan will also be performed, at selected centers, at study entry and week 96. Patients will be asked to complete a symptom distress questionnaire at study entry, weeks 12, 24, 48 and 96.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE HIV-1
Intervention  ICMJE
  • Drug: Maraviroc + Zidovudine/Lamivudine
    maraviroc (UK-427,857) 300 mg once daily added to zidovudine/lamivudine (300 mg/150 mg twice daily)
  • Drug: Efavirenz + Zidovudine/Lamivudine
    efavirenz (600 mg once daily) added to zidovudine/lamivudine (300 mg/150 mg twice daily)
  • Drug: Maraviroc (UK-427,857) + Zidovudine/Lamivudine
    maraviroc (UK-427,857) 300 mg twice daily added to zidovudine/lamivudine (300 mg/150 mg twice daily)
Study Arms  ICMJE
  • Experimental: 1
    Intervention: Drug: Maraviroc + Zidovudine/Lamivudine
  • Active Comparator: 3
    Intervention: Drug: Efavirenz + Zidovudine/Lamivudine
  • Experimental: 2
    Following a review of the interim analysis data, the DSMB recommended to terminate the UK-427,857 300 mg QD arm based on pre-specified protocol non-inferiority criteria not being met for the QD arm versus efavirenz
    Intervention: Drug: Maraviroc (UK-427,857) + Zidovudine/Lamivudine
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 6, 2013)		916
Original Enrollment  ICMJE Not Provided
Actual Study Completion Date  ICMJE December 2012
Actual Primary Completion Date April 2007   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Men or women at least 16 years of age (or minimum age as determined by local regulatory authorities)
  • HIV-1 RNA viral load of greater than or equal to 2, 000 copies/mL
  • A negative urine pregnancy test at the baseline visit for Women of Child Bearing Potential (WOCBP)
  • Effective barrier contraception for WOCBP and males

Exclusion Criteria:

  • Suspected or documented active, untreated HIV-1 related opportunistic infection (OI) or other condition requiring acute therapy
  • Treatment for an active opportunistic infection, or unexplained temperature >38.5 degrees Celsius for 7 consecutive days
  • Prior treatment with efavirenz, zidovudine or lamivudine or with any other antiretroviral therapy for more than 14 days at any time
  • Active alcohol or substance abuse sufficient, in the Investigator's judgment, to prevent adherence to study medication and/or follow up
  • Lactating women, or planned pregnancy during the trial period
  • Suspected primary (acute) HIV-1 infection
  • Previous therapy with a potentially myelosuppressive, neurotoxic, hepatotoxic and/or cytotoxic agent within 30 days prior to randomization or the expected need for such therapy during the study period
  • Documented or suspected acute hepatitis or pancreatitis within 30 days prior to randomization
  • Significantly elevated liver enzymes or cirrhosis
  • Significant neutropenia, anemia or thrombocytopenia
  • Malabsorption or an inability to tolerate oral medications
  • Symptomatic postural hypotension or severe cardiovascular or cerebrovascular disease
  • Certain medications
  • Genotypic or phenotypic resistance to efavirenz, zidovudine or lamivudine
  • X4- or dual/mixed-tropic virus or repeated assay failure
  • Any other clinical condition that, in the Investigator's judgement, would potentially compromise study compliance or the ability to evaluate safety/efficacy
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 16 Years and older   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Argentina,   Australia,   Belgium,   Brazil,   Canada,   Italy,   Mexico,   Netherlands,   Poland,   Puerto Rico,   South Africa,   Switzerland,   United Kingdom,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00098293
Other Study ID Numbers  ICMJE A4001026
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party ViiV Healthcare
Study Sponsor  ICMJE ViiV Healthcare
Collaborators  ICMJE Pfizer
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS Account ViiV Healthcare
Verification Date August 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP