Status:
COMPLETED
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
Lead Sponsor:
ViiV Healthcare
Collaborating Sponsors:
Pfizer
Conditions:
HIV Infections
Eligibility:
All Genders
16+ years
Phase:
PHASE2
PHASE3
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 cla...
Eligibility Criteria
Inclusion
- 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 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
- 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 judgement, to prevent adherence to study medication and/or follow up
- Lactating women, or planned pregnancy during the trial period
- Significant renal insufficiency
- Previous therapy with a potentially myelosuppressive, neurotoxic, hepatoxic 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
- 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
Key Trial Info
Start Date :
November 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2011
Estimated Enrollment :
601 Patients enrolled
Trial Details
Trial ID
NCT00098306
Start Date
November 1 2004
End Date
April 1 2011
Last Update
April 27 2012
Active Locations (22)
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1
Pfizer Investigational Site
Sacramento, California, United States, 95825
2
Pfizer Investigational Site
San Francisco, California, United States, 94115
3
Pfizer Investigational Site
San Francisco, California, United States, 94118
4
Pfizer Investigational Site
San Francisco, California, United States, 94121