Nerve Damage in Patients With HIV Infection Who Have Been Treated With Anti-HIV Drugs

Completed

Conditions studied: HIV Infections, Peripheral Nervous System Disease

In brief

The purpose of this study is to find out what might increase nerve damage in people with HIV who have taken drugs for treatment of HIV disease. Another purpose is to see if nerve exams are done correctly before clinical research sites enroll HIV-infected patients. Nerve damage is common in patients with HIV infection and can cause serious problems. The factors that place patients at risk are not well understood. This study will examine these factors in patients with advanced HIV infection and who have been taking anti-HIV drugs.

Key facts

Study ID

NCT00017771

Run by

National Institute of Allergy and Infectious Diseases (NIAID)

People needed

100

Starts

2001-06-01

Expected to finish

2004-07-01

Last updated by the study team

2013-07-29

Who can join

Age: 13 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Control volunteers will be eligible for this study if they:
• Are HIV negative.
• Are at least 18 years old.
• Patients will be eligible for this study if they:
• Are HIV positive.
• Are at least 13 years old and can provide written consent from parent or guardian if under 18 years of age.
• Have taken anti-HIV drugs for at least 15 straight weeks any time in the past.
• Have a CD4 count of less than 300 cells/mm3.

You may not qualify if…

• Control volunteers will not be eligible for this study if they:
• Have any nerve-related problems.
• Have diabetes and nerve damage related to diabetes.
• Have long-term illness the doctor feels would interfere with the study.
• Patients will not be eligible for this study if they:
• Have had spinal surgery.
• Have taken insulin or oral hypoglycemic products for diabetes mellitus within 30 days prior to study entry. Dietary control for diabetes is allowed.
• Have nerve damage related to diabetes.
• Have a nerve condition unrelated to HIV infection or antiretroviral therapy.
• Have alcohol-related medical complications within 6 months of study entry.
• Have vitamin B12 levels of less than 200 pg/ml or a history of vitamin B12 deficiency.
• This study has been changed to modify the exclusion criteria. Earlier versions did not include some of these exclusion criteria.

Where it is running

• Univ of Alabama at Birmingham — Birmingham, Alabama, United States
• UCLA CARE Ctr — Los Angeles, California, United States
• Univ of Colorado Health Sciences Ctr — Denver, Colorado, United States
• Univ of Hawaii — Honolulu, Hawaii, United States
• The CORE Ctr — Chicago, Illinois, United States
• Indiana Univ Hosp — Indianapolis, Indiana, United States
• Methodist Hosp of Indiana / Life Care Clinic — Indianapolis, Indiana, United States
• Wishard Hosp — Indianapolis, Indiana, United States
• Johns Hopkins Hosp — Baltimore, Maryland, United States
• Washington Univ / St Louis Connect Care — St Louis, Missouri, United States
• Washington Univ School of Medicine — St Louis, Missouri, United States
• Beth Israel Med Ctr — New York, New York, United States
• Cornell Univ Med Ctr — New York, New York, United States
• Univ of Rochester Medical Center — Rochester, New York, United States
• Univ of Pennsylvania — Philadelphia, Pennsylvania, United States
• Mount Sinai Med Ctr — Pittsburgh, Pennsylvania, United States
• Univ of Texas, Southwestern Med Ctr of Dallas — Dallas, Texas, United States
• Univ of Washington — Seattle, Washington, United States

Full record on ClinicalTrials.gov

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