A Study Comparing Long-acting Methylphenidate (ConcertaTM) vs. Placebo in the Treatment of Memory Loss Due to HIV
Recruitment status was: Recruiting
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.
|HIV Dementia||Drug: Long acting methylphenidate Drug: Matched placebo||Phase 3|
|Study Design:||Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double Blind (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||Phase III, Placebo-Controlled, Double-Blind Crossover Study of Slow-Release Methylphenidate (Concerta ™) for Treatment of HIV Associated Neurocognitive Disorder|
- Change in rate of reaction time as measured by neuropsychological testing [ Time Frame: 10 weeks of study drug exposure ]The Conner's CPT-II at screening, and at weeks 1, 5, and 14.
- 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 ]The number of subjects who develop adverse events while on study medication vs placebo will be used to measure the safety and tolerability of ConcertaTM at 36 mg a day in this population of adult subjects with HIV over both a two week and eight week treatment period. These measures are EKG changes, electrolyte, creatinine, liver function tests, blood pressure, quality of life and sleep quality scales.
|Study Start Date:||May 2012|
|Estimated Study Completion Date:||September 2014|
|Estimated Primary Completion Date:||May 2014 (Final data collection date for primary outcome measure)|
Active Comparator: Group A: 2 tabs of 18 mg Concerta daily
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.
Drug: Long acting methylphenidate
Treatment with long-acting methylphenidate, 36 mg a day as 2 tablets of 18 mg each.
Other Name: ConcertaDrug: Long acting methylphenidate
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.
Placebo Comparator: Group B: Matched placebo, 2 tabs daily
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.
Drug: Matched placebo
2 tablets of matched placebo daily by mouth
Other Name: Matched placebo as supplied by Johnson and Johnson
Show Detailed Description
Please refer to this study by its ClinicalTrials.gov identifier: NCT01599975
|Contact: Alejandro T. Ponce, M.D.||310 557 firstname.lastname@example.org|
|Contact: Ardis A. Moe, M.D.||310 557 email@example.com|
|United States, California|
|UCLA CARE Clinic||Recruiting|
|Los Angeles, California, United States, 90035|
|Contact: Alejandro T. Ponce, M.D. 310-557-9916 firstname.lastname@example.org|
|Contact: Ardis A. Moe, M.D. 310 557 2273 email@example.com|
|Principal Investigator: Ardis A. Moe, M.D.|
|Principal Investigator:||Ardis A Moe, M.D.||UCLA Center for AIDS Research and Educationi|