Status:
COMPLETED
Study of Pregabalin Versus Placebo in the Treatment of Nerve Pain Associated With HIV Neuropathy
Lead Sponsor:
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Conditions:
HIV Infections
Peripheral Neuropathy
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
Study to determine if pregabalin is more effective than placebo in treating subjects with nerve pain associated with HIV neuropathy.
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
October 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2007
Estimated Enrollment :
302 Patients enrolled
Trial Details
Trial ID
NCT00232141
Start Date
October 1 2005
End Date
November 1 2007
Last Update
February 9 2021
Active Locations (44)
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1
Pfizer Investigational Site
Birmingham, Alabama, United States, 35294
2
Pfizer Investigational Site
Phoenix, Arizona, United States, 85023
3
Pfizer Investigational Site
Little Rock, Arkansas, United States, 72207
4
Pfizer Investigational Site
Los Angeles, California, United States, 90025