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

Viatris

Status and phase: Completed; Phase 3

Conditions: Peripheral Neuropathy; HIV Infections

Treatments: Drug: Placebo; Drug: pregabalin

Study type: Interventional

Funder types: Industry

Identifiers

NCT00232141

A0081066

Details and patient eligibility

About

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

Enrollment: 302 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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302 participants in 2 patient groups, including a placebo group

1

Experimental group

Treatment:

Drug: pregabalin

2

Placebo Comparator group

Treatment:

Drug: Placebo