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
Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
ViiV Healthcare
With
Pfizer
Age
16–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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
You may not be if
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
Clareo Health | 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
