At a glance
ClinicalIndex Comparison Record- ✓Age ≥16 years
- ✓HIV-1 RNA viral load ≥5,000 copies/mL
- ✓Documented genotypic or phenotypic resistance to ≥3 antiretroviral drug classes, OR extensive experience (≥6 months) with ≥3 drug classes including NRTIs, NNRTIs, PIs, and/or enfuvirtide
- ✓Stable antiretroviral regimen or no antiretrovirals for ≥4 weeks prior to baseline
- ✕X4- or dual/mixed-tropic virus or repeated assay failure
- ✕Prior treatment with maraviroc or another experimental HIV entry inhibitor for >14 days
- ✕Active, untreated HIV-1-related opportunistic infection or condition requiring acute therapy
- ✕Active opportunistic infection treatment or unexplained fever >38.5°C for ≥7 consecutive days
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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
In Brief
A Phase 3 clinical trial evaluating Maraviroc (UK-427,857) and optimized background therapy for HIV Infections. Completed, enrolled 474 participants across 172 sites in 13 countries.
Detailed 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.
Study Details
Timeline
Interventions
maraviroc (UK-427,857) 150 mg taken once daily, OBT + maraviroc (UK-427,857) 150 mg taken twice daily, or OBT alone.
\[OBT (3-6 drugs based on treatment history and resistance testing)\]
maraviroc (UK-427,857) 150 mg taken twice daily
\[OBT (3-6 drugs based on treatment history and resistance testing)\]
\[OBT (3-6 drugs based on treatment history and resistance testing)\]