Status:
COMPLETED
Trial of Maraviroc (UK-427,857) in Combination With Zidovudine/Lamivudine Versus Efavirenz in Combination With Zidovudine/Lamivudine
Lead Sponsor:
ViiV Healthcare
Collaborating Sponsors:
Pfizer
Conditions:
HIV-1
Eligibility:
All Genders
16+ years
Phase:
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 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
- 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
Key Trial Info
Start Date :
November 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2012
Estimated Enrollment :
916 Patients enrolled
Trial Details
Trial ID
NCT00098293
Start Date
November 1 2004
End Date
December 1 2012
Last Update
October 9 2013
Active Locations (144)
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1
Pfizer Investigational Site
Birmingham, Alabama, United States, 35233
2
Pfizer Investigational Site
Birmingham, Alabama, United States, 35294-2050
3
Pfizer Investigational Site
Beverly Hills, California, United States, 90211
4
Pfizer Investigational Site
Los Angeles, California, United States, 90022