Conditions: Neuropathy
Keywords: neuropathy pain HIV-1 HIV Infections
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 377
Healthy volunteers: no

Brief summary:
The purpose of this study is to evaluate the efficacy of pregabalin compared to placebo in reducing neuropathic pain associated with HIV neuropathy.

Detailed description:
Based on DMC interim efficacy analysis results indicating a low probability for success the study was terminated on April 2, 2012; the termination was unrelated to any safety findings that could impact patient health.

Arms:
arm 1: None arm 2: None

Interventions: intervention 1: pregabalin intervention 2: placebo
Intervention descriptions: intervention 1: Pregabalin 75 mg-300mg twice daily during the course of the study. intervention 2: Subjects may be assigned to placebo during this study. The study duration is approximately 19 weeks.

Protocol document: