A Double-Blind, Placebo-Controlled Trial of Maraviroc in Treatment-Experienced Patients Infected with Non-R5 HIV-1

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Abstract

Background

Maraviroc, a CCR5 antagonist, is active against R5 but not X4 or dual- or mixed-tropic strains of human immunodeficiency virus type 1 (HIV-1). A phase 2b study was conducted to determine the safety and efficacy of maraviroc in combination with optimized background therapy in treatment-experienced patients infected with dual- or mixed-tropic HIV-1.

Methods

Treatment-experienced patients with an HIV-1 RNA level ≥5000 copies/mL who had received ≥3 classes of drugs and/or were infected with virus resistant to 2 drug classes and were infected with non-R5 HIV-1 were randomized to receive optimized background therapy plus maraviroc (once or twice daily) or placebo. The primary end point was change in HIV-1 RNA level from baseline to 24 weeks.

Results

Among 167 patients infected with dual- or mixed-tropic HIV-1, baseline mean HIV-1 RNA levels were >5 log10 copies/mL and median CD4+ cell counts were <50 cells/μL. From baseline to 24 weeks, patients who received placebo demonstrated a mean decrease in HIV-1 RNA levels of 0.97 log10 copies/mL, compared with mean decreases of 0.91 and 1.20 log10 copies/mL for those who received maraviroc once (P=.83) or twice (P=.38) daily, respectively. Mean increases in CD4+ cell counts from baseline were 36 cells/μL for patients who received placebo, 60 cells/μL among patients who received maraviroc once daily, and 62 cells/μL among patients who received maraviroc twice daily. The incidences of serious adverse events were similar among groups.

Conclusions

In this exploratory study involving extensively treatment-experienced patients with advanced, non-R5 HIV-1 infection, neither superiority nor noninferiority was statistically demonstrated for either maraviroc dosage compared with placebo at 24 weeks of treatment.

Trial registration

Clinicaltrials.gov identifier NCT00098748.

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