Clinical Trial: A Study Comparing Long-acting Methylphenidate (ConcertaTM) vs. Placebo in the Treatment of Memory Loss Due to HIV

Study Status: Terminated
Recruit Status: Unknown status
Study Type: Interventional

Official Title: Phase III, Placebo-Controlled, Double-Blind Crossover Study of Slow-Release Methylphenidate (Concerta ™) for Treatment of HIV Associated Neurocognitive Disorder

Brief Summary:

This study is being done to see if a drug called long acting methylphenidate (Concerta) is safe and effective as a treatment for problems with mental function in adults infected with HIV.

A subset of patients with HIV-associated memory loss have a defect in the speed with which they learn and process information. Methylphenidate drugs, such as Ritalin or Concerta, have been shown on tests to improve the ability to rapidly absorb information; these tests are called "reaction time tests". These drugs are already FDA-approved to treat Attention Deficit Disorders: ADD or ADHD.

At baseline, all subjects get tests of memory and brain function; then they are split into two groups. One group on this study will receive Concerta for 2 weeks, and a second group will receive a placebo x 2 weeks. After that period both groups will receive memory and other tests of brain function, and then the groups will switch. The first group will receive placebo and the second will receive Concerta x 2 weeks, followed by more memory and neurological tests. After that all subjects will have the option to receive Concerta for free for 8 more weeks. At the last visit all subjects get memory and brain tests again.

Detailed Summary:

There are 11 study visits in 14 weeks.

In Part I of the study one-half of the subjects will receive ConcertaTM and one-half will receive placebo.

After 2 weeks all subjects will stop their study medication for 2 week (the "washout period"), and then all of the subjects who received placebo will then receive 2 weeks of methylphenidate, and all of the subjects who received long acting methylphenidate will receive placebo for 2 weeks.

The subject will be invited to enter Part II of the study if she/he still qualifies. During this portion of the study, the subject will receive ConcertaTM for 8 weeks. The subject does not have to be on Part II of this study to be on this study.

Screening visit. (4 hours)

There is a screening medical visit. If the subject passes the initial questions for depression and dementia, the subject will undergo the following procedures:

There will be a physical examination including a medical and medication history, which will include telling the study staff about all of the drugs that the subject has taken recently or are currently taking, and measurement of vital signs (blood pressure, temperature, height, weight, pulse,breathing rate).

The subject will have a physical examination including a detailed test of reflexes, muscle strength,gait, balance, and other functions of brain and nerves to see if he/she has any nerve damage and to see how the brain functions. The subject will take a group of tests called neuropsychological tests. The subject will answer questions, do simple tasks with their hands, and see how long it takes her/him to walk a sho
Sponsor: University of California, Los Angeles

Current Primary Outcome: Change in rate of reaction time as measured by neuropsychological testing [ Time Frame: 10 weeks of study drug exposure ]

Original Primary Outcome: Same as current

Current Secondary Outcome: Number of Subjects with Adverse Events as Measures of Safety and Tolerability of Concerta in HIV infected adults [ Time Frame: 10 weeks of drug exposure ]

Original Secondary Outcome: Same as current

Information By: University of California, Los Angeles

Dates:
Date Received: May 7, 2012
Date Started: May 2012
Date Completion: September 2014
Last Updated: May 14, 2012
Last Verified: May 2012