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

Stopped early · Phase 3 · Has a placebo group

Conditions studied: Neuropathy

In brief

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

Key facts

Study ID

NCT01049217

Run by

Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

People needed

377

Starts

2010-04-01

Expected to finish

2012-05-01

Last updated by the study team

2021-01-28

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• SW Center for HIV/AIDS — Phoenix, Arizona, United States
• Arizona Research Center — Phoenix, Arizona, United States
• AIDS Research Alliance of America — Los Angeles, California, United States
• Anthony Mills, MD, Inc. — Los Angeles, California, United States
• David Geffen School of Medicine at UCLA c/o NNAB — Los Angeles, California, United States
• Providence Clinical Research — North Hollywood, California, United States
• Desert Medical Group, Inc. dba Desert Oasis Healthcare Medical Group — Palm Springs, California, United States
• University of California San Diego — San Diego, California, United States
• Stanford University Medical Center — Stanford, California, United States
• Neuroscience Consultants, LLC. — Aventura, Florida, United States
• South Florida Medical Research — Aventura, Florida, United States
• The Kinder Medical Group — Miami, Florida, United States
• Wohlfeiler, Piperato & Associates, LLC — Miami Beach, Florida, United States
• Meridien Research — Tampa, Florida, United States
• AIDS Research Consortium of Atlanta — Atlanta, Georgia, United States
• Midtown Neurology, PC — Atlanta, Georgia, United States
• Neurology Specialists of Decatur Research Center — Decatur, Georgia, United States
• Rehabilitation Institute of Chicago — Chicago, Illinois, United States
• Mount Sinai School of Medicine — New York, New York, United States
• University of Toledo Medical Center — Toledo, Ohio, United States
• University of Toledo — Toledo, Ohio, United States
• University of Texas Physicians — Bellaire, Texas, United States
• Amelia Court HIV Research Clinic — Dallas, Texas, United States
• The University of Texas Medical School at Houston — Houston, Texas, United States
• Southwest Center for HIV/AIDS — Phoenix, Arizona, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.