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

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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

302 participants in 2 patient groups, including a placebo group

1
Experimental group
Treatment:
Drug: pregabalin
2
Placebo Comparator group
Treatment:
Drug: Placebo

Trial contacts and locations

44

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Data sourced from clinicaltrials.gov

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