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

Last updated on February 22, 2019

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Study Location
Southwest Center for HIV/AIDS
Phoenix, Arizona, 85006 United States
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Neuropathy
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18 + years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
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- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
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- Subject has untreated vitamin B12 deficiency (serum B12 level 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

NCT01049217
Pfizer
Terminated
Pregabalin Versus Placebo In The Treatment Of Neuropathic Pain Associated With HIV Neuropathy

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