Open Label Safety And Efficacy Study Of Pregabalin In Subjects With Nerve Pain Asociated With Human Immunodeficiency Virus (HIV) Neuropathy

Viatris

Status and phase: Completed; Phase 3

Conditions: Peripheral Neuropathy; HIV Infections

Treatments: Drug: pregabalin

Study type: Interventional

Funder types: Industry

Identifiers

NCT00264875

A0081095

Details and patient eligibility

About

To evaluate the safety and efficacy of pregabalin in reducing neuropathic pain associated with HIV neuropathy

Enrollment: 220 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Participation in the preceding A0081066 double-blind trial met the entry criteria for that trial and completed A0081066 study through visit 7

Exclusion criteria

• Experienced serious adverse event during the A0081066 trial that was considered related or possibly related to study medication by the investigator or sponsor
• non-compliant during A0081066 trial
• clinically significant or unstable medical condition both HIV-related and non-HIV related including but not limited to, cardiac, pulmonary or hepatorenal disease that, in the opinion of the investigator, would compromise participation in the study

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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220 participants in 1 patient group

1

Experimental group

Treatment:

Drug: pregabalin