CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 302 enrolled
Drug / intervention
pregabalin +1 moredrug
Likely dose
Pregabalin 75 mg BID, titrated up to 150 mg BID on day 4, and up to 300 mg BID by end of week 2AI-extracted
Key inclusion· 4
  • ✓Confirmed diagnosis of HIV infection
  • ✓HIV-associated neuropathic pain for at least 3 months prior to study start
  • ✓Moderate to severe pain
  • ✓On stable HIV and pain medications (some medications not allowed during study)
Key exclusion· 5
  • ✕Pregnant or breast feeding
  • ✕Street drug use or alcohol abuse during the study
  • ✕Use of antidiabetic medications
  • ✕Neuroregenerative agents or neurotoxic chemotherapy within 3 months prior to study start and throughout study

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00232141
NCT00232141Phase 3Completed
CompareCT.gov

A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multi-Center Trial of Pregabalin Versus Placebo in the Treatment of Neuropathic Pain Associated With HIV Neuropathy.

Pfizer's Upjohn has merged with Mylan to form Viatris Inc.·interventional·Posted Oct 4, 2005·Updated Feb 9, 2021

In Brief

A Phase 3 clinical trial evaluating pregabalin and Placebo for HIV Infections and Peripheral Neuropathy. Completed, enrolled 302 participants across 44 sites in 2 countries.

Detailed Summary

Study to determine if pregabalin is more effective than placebo in treating subjects with nerve pain associated with HIV neuropathy.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHIV Infections, Peripheral Neuropathy
CountriesPuerto Rico, United States
Collaborators--

Timeline

Phase 3CompletedFinished
2006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedOct 4, 2005
Enrollment StartOct 1, 2005
Primary CompletionNov 1, 2007
TodayJul 2, 2026
Enrollment to primary: 2.1 yearsPosted 20.7 years ago

Interventions

pregabalindrug

75mg BID (can be titrated up to 150mg BID on day 4 based on individual response and up to 300mg BID at the end of week 1, visit 3 and end of week 2, visit 4)

Placebodrug

Placebo