MedTrace Logo

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

NCT01599975 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2012-05-16

No results posted yet for this study

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.

Conditions

  • HIV Dementia

Interventions

DRUG

Long acting methylphenidate

Treatment with long-acting methylphenidate, 36 mg a day as 2 tablets of 18 mg each.

DRUG

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.

DRUG

Matched placebo

2 tablets of matched placebo daily by mouth

Sponsors & Collaborators

Principal Investigators

  • Ardis A Moe, M.D. · UCLA Center for AIDS Research and Educationi

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
64 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-05-31
Primary Completion
2014-05-31
Completion
2014-09-30

Countries

  • United States

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01599975 on ClinicalTrials.gov