Pregabalin Versus Placebo In The Treatment Of Neuropathic Pain Associated With HIV Neuropathy

Viatris

Status and phase

Terminated

Phase 3

Conditions

Neuropathy

Treatments

Drug: pregabalin

Drug: placebo

Study type

Interventional

Funder types

Industry

Identifiers

NCT01049217

A0081244

Details and patient eligibility

About

The purpose of this study is to evaluate the efficacy of pregabalin compared to placebo in reducing neuropathic pain associated with HIV neuropathy.

Full description

Based on DMC interim efficacy analysis results indicating a low probability for success the study was terminated on April 2, 2012; the termination was unrelated to any safety findings that could impact patient health.

Enrollment

377 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Men and women, ages of 18 or greater
Documented evidence of HIV-1 infection
Documented diagnosis of HIV-associated Distal Symmetrical Polyneuropathy (DSP) with subjective sensory symptom of pain
Pain starts in the feet

Exclusion criteria

Subject has untreated vitamin B12 deficiency (serum B12 level <200 pg/ml) or if treated B12 deficiency -treatment is less than 6 months of B12 supplementation (injection or intranasal B12) prior to screening
Diabetes mellitus requiring regular medical treatment (other than diet and exercise) or HbA1C >6.9
Subjects with peripheral neuropathic pain that is not associated with HIV infection; including subjects with conditions such as: Post Herpetic Neuralgia (PHN), Diabetic Peripheral Neuropathy (DPN), familial neuropathies; compression related neuropathy, radicular pain, other infection related neuropathies (eg, leprosy); neuropathy related to: metabolic abnormalities; nutritional factors; vascular insults; inflammation; autoimmune disease; and malignancy