Trial of Maraviroc (UK-427,857) in Combination With Optimized Background Therapy Versus Optimized Background Therapy Alone for the Treatment of HIV-1 Infected Subjects

NCT00098722

Last updated date
Study Location
Pfizer Investigational Site
Hobson City, Alabama, 36201, United States
Contact
1-800-718-1021

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 Infections
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 yers of age (or minimum age as determined by local regulatory authorities)

- HIV-1 RNA viral load of greater than or equal to 5,000 copies/mL

- Stable pre-study antiretroviral regimen, or on no antiretroviral agents, for at least 4 weeks

- Documented genotypic or phenotypic resistance to three of the four antiretroviral drug classes, OR, Antiretroviral-class experience greater than or equal to 6 months (sequential or cumulative) with at least three of the following: One nucleoside or nucleotide reverse transcriptase inhibitor, one non-nucleoside reverse transcriptase inhibitor, two protease inhibitors (excluding low-dose ritonavir) and/or enfuvirtide

- Be willing to remain on randomized treatment without any changes or additions to the OBT regimen, except for toxicity management or upon meeting criteria for treatment failure

- 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


- Patients requiring treatment with more than 6 antiretroviral agents (excluding
low-dose ritonavir)


- Prior treatment with maraviroc (UK-427,857) or another experimental HIV entry
inhibitor for more than 14 days


- 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


- 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


- Significant renal insufficiency


- Initiating therapy with a potentially myelosuppressive, neurotoxic, hepatotoxic and/or
cytotoxic agent within 60 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


- Certain medications


- Malignancy requiring parenteral chemotherapy that must be continued for the duration
of the trial


- 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]

TRY A NEW SEARCH

Search for Clinical Trials by condition, keyword or trial number. Share your location or enter your city or zip code to find studies near you.

Based on your search, you may also be interested in

HIV InfectionsMaraviroc Intensification and Peripheral Blood Monocyte HIV DNA Levels
NCT00987948
  1. Honolulu, Hawaii
ALL GENDERS
18 Years+
years
MULTIPLE SITES
HIV InfectionsKaletra and Maraviroc in Antiretroviral Therapy (ART)-Naive Patients (KALMAR Study)
NCT01068873
  1. Philadelphia, Pennsylvania
ALL GENDERS
18 Years+
years
MULTIPLE SITES
HIV InfectionsStudy of the Antiviral and Immunological Effects of Intensification of Suppressive Antiretroviral Therapy With Maraviroc
NCT00703586
  1. New York, New York
ALL GENDERS
18 Years+
years
MULTIPLE SITES
HIV InfectionsMaraviroc Immune Recovery Study
NCT00875368
  1. Amsterdam,
  2. Amsterdam,
  3. Amsterdam,
  4. Arnhem,
  5. Haarlem,
  6. Leiden,
  7. Rotterdam,
  8. Rotterdam,
  9. Tilburg,
  10. Utrecht,
ALL GENDERS
18 Years+
years
MULTIPLE SITES
Advanced Information
Descriptive Information
Brief Title  ICMJE Trial of Maraviroc (UK-427,857) in Combination With Optimized Background Therapy Versus Optimized Background Therapy Alone for the Treatment of HIV-1 Infected Subjects
Official Title  ICMJE A Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial of a Novel CCR5 Antagonist, UK-427,857, in Combination With Optimized Background Therapy Versus Optimized Background Therapy Alone for the Treatment of Antiretroviral-Experienced 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 purpose of this study is to evaluate the antiretroviral activity of maraviroc (UK-427,857) in HIV infected, treatment experienced patients who are failing their current antiretroviral regimen and infected with R5-tropic virus exclusively. This study will involve more than 100 centers in Europe and Australia to achieve a total randomized subject population of 500 subjects. Patients will be randomly (2:2:1) assigned to one of three groups: Optimized Background Therapy [OBT (3-6 drugs based on treatment history and resistance testing)] + maraviroc (UK-427,857) 150 mg taken once daily, OBT + maraviroc (UK-427,857) 150 mg taken twice daily, or OBT alone. The study will enroll over approximately a 9 month period with 48 weeks of treatment. This may be extended for an additional year depending on the results at 48 weeks. Physical examinations will be performed at study entry, weeks 4, 8, 12, 16, 20, 24, 32, 40 and 48. Blood samples will also be taken at study entry, weeks 2, 4, 8, 12, 16, 20, 24, 32, 40 and 48. Additionally, blood samples will be drawn twice, at least 30 minutes apart, at weeks 2 and 24 for maraviroc (UK-427,857) pharmacokinetic analysis. As part of this clinical study a blood sample will also be taken for non-anonymized pharmacogenetic analysis. Patients will undergo a 12-lead electrocardiogram at study entry, weeks 24 and 48.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
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 Infections
Intervention  ICMJE
  • Drug: Maraviroc (UK-427,857)
    maraviroc (UK-427,857) 150 mg taken once daily, OBT + maraviroc (UK-427,857) 150 mg taken twice daily, or OBT alone.
  • Drug: optimized background therapy
    [OBT (3-6 drugs based on treatment history and resistance testing)]
    Other Name: Selzentry
  • Drug: Maraviroc (UK-427,857)
    maraviroc (UK-427,857) 150 mg taken twice daily
    Other Name: Selzentry
  • Drug: optimized background therapy
    [OBT (3-6 drugs based on treatment history and resistance testing)]
Study Arms  ICMJE
  • Experimental: 1
    Interventions:
    • Drug: Maraviroc (UK-427,857)
    • Drug: optimized background therapy
  • Placebo Comparator: 2
    Interventions:
    • Drug: Maraviroc (UK-427,857)
    • Drug: optimized background therapy
  • Experimental: 3
    Intervention: Drug: optimized background therapy
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: April 16, 2012)
474
Original Enrollment  ICMJE Not Provided
Actual Study Completion Date  ICMJE April 2011
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 yers of age (or minimum age as determined by local regulatory authorities)
  • HIV-1 RNA viral load of greater than or equal to 5,000 copies/mL
  • Stable pre-study antiretroviral regimen, or on no antiretroviral agents, for at least 4 weeks
  • Documented genotypic or phenotypic resistance to three of the four antiretroviral drug classes, OR, Antiretroviral-class experience greater than or equal to 6 months (sequential or cumulative) with at least three of the following: One nucleoside or nucleotide reverse transcriptase inhibitor, one non-nucleoside reverse transcriptase inhibitor, two protease inhibitors (excluding low-dose ritonavir) and/or enfuvirtide
  • Be willing to remain on randomized treatment without any changes or additions to the OBT regimen, except for toxicity management or upon meeting criteria for treatment failure
  • 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:

  • Patients requiring treatment with more than 6 antiretroviral agents (excluding low-dose ritonavir)
  • Prior treatment with maraviroc (UK-427,857) or another experimental HIV entry inhibitor for more than 14 days
  • 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
  • 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
  • Significant renal insufficiency
  • Initiating therapy with a potentially myelosuppressive, neurotoxic, hepatotoxic and/or cytotoxic agent within 60 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
  • Certain medications
  • Malignancy requiring parenteral chemotherapy that must be continued for the duration of the trial
  • 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 Australia,   Belgium,   Canada,   France,   Germany,   Italy,   Netherlands,   Poland,   Spain,   Sweden,   Switzerland,   United Kingdom,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00098722
Other Study ID Numbers  ICMJE A4001028
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 April 2012

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