Study of Pregabalin Versus Placebo in the Treatment of Nerve Pain Associated With HIV Neuropathy

• Status: Completed
• Trial end date: 2007-11-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Pfizer; Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
• Treatments: Pregabalin

Criteria

Inclusion Criteria:

• Subjects with confirmed diagnosis of HIV infection

• HIV-associated neuropathic pain (nerve pain) for at least 3 months prior to study start

• subjects with moderate to severe pain

• subjects on stable HIV and pain medications (some medications are not allowed to be taken while participating in the study).

Exclusion Criteria:

• Pregnant or breast feeding females

• subjects using street drugs or alcohol abusers during the study

• subject's on anti-diabetic medications

• use of neuroregenerative agents or neurotoxic chemotherapeutic agents 3 months prior to study start and throughout the study

• use of neurotoxic drugs (other than D-drugs) within a month prior to study start and throughout the study.