Phase III, Placebo-Controlled, Double-Blind Crossover Study of Slow-Release Methylphenidate (Concerta ™) for Treatment of HIV Associated Neurocognitive Disorder
Sponsor study identifier
interventional
40
1 country
1
Study Start
May 2012
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
May 2014
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
September 2014
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
September 2014
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
May 2012
Date type not reportedThis date has not been verified as actual or estimated.
May 7, 2012
Actual (reported)May 16, 2012
Actual (reported)May 2014
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
September 2014
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Change in rate of reaction time as measured by neuropsychological testing
The Conner's CPT-II at screening, and at weeks 1, 5, and 14.
10 weeks of study drug exposure
Number of Subjects with Adverse Events as Measures of Safety and Tolerability of Concerta in HIV infected adults
10 weeks of drug exposure
20 subjects to receive active study drug in a blinded fashion x 2 weeks, then washout x 2 weeks, then cross over to receive matched placebo x 2 weeks.
Group B to receive matched placebo x 2 weeks, then washout x 2 weeks, then cross over to receive active drug in a blinded fashion x 2 weeks.
Treatment with long-acting methylphenidate, 36 mg a day as 2 tablets of 18 mg each.
18 mg tablets, 2 tablets daily by mouth x 2 weeks, then washout x 2 weeks, then crossover to 2 tablets of matched placebo x 2 weeks.
These entries preserve how the registry describes the intervention. Their treatment roles are shown separately from molecular identities.
Control intervention
Matched placebo
The registry describes a control or simulated intervention. Active treatment exposure is not inferred.
View registry recordUCLA CARE Clinic
Los Angeles, California, 90035, United States
Ardis A Moe, M.D.
UCLA Center for AIDS Research and Educationi
First Submitted
May 7, 2012
First Posted
May 16, 2012
Study Start
May 2012
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
A Multicenter Placebo-Controlled Double-Blind Trial to Evaluate Azidothymidine (AZT) Treatment of the AIDS Dementia Complex and Central Nervous System (CNS) Human Immunodeficiency Virus (HIV) Infection
2 tablets of matched placebo daily by mouth
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
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May 2014
This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
September 2014
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
May 16, 2012
Record last verified: 2012-05
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Source: ClinicalTrials.gov.
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