Status:
COMPLETED
Trial of Maraviroc (UK-427,857) in Combination With Optimized Background Therapy Versus Optimized Background Therapy Alone for the Treatment of Antiretroviral-Experienced NonCCR5-Tropic 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 co-receptor antagonist, has been shown to be active in vitro against a wide range of clinical isolates (including those resistant to existing cl...
Detailed Description
(i) Subjects remained on their assigned therapy for 48 weeks, unless the subject was discontinued early for protocol-defined treatment failure or other reasons such as adverse event, loss to follow-up...
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 two of the four antiretroviral drug classes, OR, Antiretroviral-class experience greater than or equal to 3 months (sequential or cumulative) with at least three of the following: One nucleoside or nucleotide reverse transcriptase inhibitor (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 judgment, 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, 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
- Malignancy requiring parenteral chemotherapy that must be continued for the duration of the trial
- R5 virus phenotype only
- No option to use at least one non-nucleoside reverse transcriptase inhibitor or protease inhibitor, or enfuvirtide, based on resistance testing
- Any other clinical condition that, in the Investigator's judgment, 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 2009
Estimated Enrollment :
190 Patients enrolled
Trial Details
Trial ID
NCT00098748
Start Date
November 1 2004
End Date
April 1 2009
Last Update
December 7 2010
Active Locations (77)
Enter a location and click search to find clinical trials sorted by distance.
1
Pfizer Investigational Site
Birmingham, Alabama, United States, 35294
2
Pfizer Investigational Site
Phoenix, Arizona, United States, 85006
3
Pfizer Investigational Site
Beverly Hills, California, United States, 90211
4
Pfizer Investigational Site
Fountain Valley, California, United States, 92708