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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2012 by University of California, Los Angeles.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
Ardis Ann Moe, M.D., University of California, Los Angeles
ClinicalTrials.gov Identifier:
NCT01599975
First received: May 7, 2012
Last updated: May 14, 2012
Last verified: May 2012
  Purpose

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.


Condition Intervention Phase
HIV Dementia
Drug: Long acting methylphenidate
Drug: Matched placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:


Further study details as provided by University of California, Los Angeles:

Primary Outcome Measures:
  • Change in rate of reaction time as measured by neuropsychological testing [ Time Frame: 10 weeks of study drug exposure ] [ Designated as safety issue: No ]
    The Conner's CPT-II at screening, and at weeks 1, 5, and 14.


Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]
    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.


Estimated Enrollment: 40
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)
Arms Assigned Interventions
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: Concerta
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.
Other Name: Long acting methylphenidate
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

  Eligibility

Ages Eligible for Study:   18 Years to 64 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

Men and women 18 years of age or older and less than 65 years of age.

Able to read and understand English.

HIV infected on stable ART regimen for 5 months or greater, and not likely to change regimen for the duration of the study.

Significant dementia but able to give consent (International HIV Dementia Scale score <10).

Significant cognitive slowing on screening, defined as 1 SD below normal (t-score >60) on the Conner's CPT-II reaction time test.

Beck Depression Inventory score <16.

Documented HIV-1 RNA PCR <50 copies/mL and documented CD4 count >200 within 3 months of entry visit.

Baseline CBC and chemistry panel Grade 1 or normal.

For females of reproductive potential (women who have not been post-menopausal for at least 24 consecutive months, i.e., who have had menses within 24 months prior to study entry), or women who have not undergone surgical sterilization, specifically hysterectomy or bilateral oophorectomy or tubal ligation) will require a negative serum or urine pregnancy test within 48 hours prior to entry.

NOTE: Subject reported history is considered acceptable documentation of hysterectomy, bilateral oophorectomy, tubal ligation, tubal micro-inserts, menopause, and vasectomy/azoospermia.

All subjects must agree not to participate in the conception process (e.g., active attempt to become pregnant or to impregnate, sperm donation, in vitro fertilization), and if participating in sexual activity that could lead to pregnancy, the subject/partner must use at least two reliable methods of contraception, (condoms, without a spermicidal agent; a diaphragm or cervical cap without spermicide; an IUD; or hormone-based contraceptive), for 2 weeks before study treatment, while receiving study treatment, and for 6 weeks after receiving study treatment.

Ability and willingness of subject to provide informed consent.

Exclusion Criteria:

Inability to give informed consent. No proxy consent allowed.

Uncontrolled hypertension (SBP >140 and DBP >90 at screening and baseline).

Untreated hypogonadism, hypothyroidism or hyperthyroidism.

Initiation of antidepressants, thyroid medication or anabolic steroids within 6 weeks of screening visit.

Pregnancy or breast feeding.

Clinically significant EKG abnormalities at screening.

History of coronary artery disease, atherosclerotic disease, left ventricular hypertrophy, cardiomegaly, syncope, congestive heart failure, myocardial infarction, pacemaker, clinically significant arrhythmia, angina, history of treatment for arrhythmia.

Brain related opportunistic infections, stroke, intracranial lesions/disease, or meningitis.

History of epilepsy.

Untreated depression.

Uncontrolled diabetes (glucose <70 or >200 at screening).

Use of interferon or ribavirin during study and for 1 month prior to screening.

History of bipolar disorder, Alzheimer's dementia, ALS, Parkinson's disease or other medical dementias other than HIV-related.

History of schizophrenia, mania or other serious mental illness.

History of methylphenidate allergy.

Other serious concurrent medical illness other than HIV.

History of radiation therapy to the brain or brain injury.

History of crystal methamphetamine, cocaine, LSD use or other recreational substance use other than marijuana within the 12 months prior to screening and for the duration of the study.

Plan to use marijuana or marinol during the entire study duration and one month prior to screening visit.

Plan to drink 7 or more alcoholic drinks per week during the 4 weeks prior to screen visit and for the duration of the study.

History of alcohol dependence, alcohol abuse, cocaine addiction, crystal methamphetamine addiction or other recreational drug addiction or treatment for addiction or dependence within 5 years of screening visit.

If subject is using prescription narcotics, should be on a stable dose for at least 1 month prior to screening and throughout the study.

Previous use of Concerta™, Ritalin™, atomexitine or Adderall™ or other psychostimulants (e.g. modafinil, armodafinil) for 3 months prior to screening visit and for duration of the study.

History of tic disorders in the past 3 months or any history of Tourette's syndrome.

Greater than 10% below ideal body weight (IBW for men = 50 kg + 2.3 kg per inch over 5 feet of height, and IBW for women = 45.5 kg + 2.3 kg per inch over 5 feet of height)

Uncontrolled migraine headaches.

History of short gut syndrome, Meckel's diverticulum, or cystic fibrosis.

Family history of sudden cardiac death in a young relative.

History of fainting with exercise.

History of attention deficit disorder will be excluded, defined as a score greater than 6 on the Childhood ADHD Symptoms Scale.

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  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01599975

Contacts
Contact: Alejandro T. Ponce, M.D. 310 557 9916 aponce@mednet.ucla.edu
Contact: Ardis A. Moe, M.D. 310 557 2273 amoe@mednet.ucla.edu

Locations
United States, California
UCLA CARE Clinic Recruiting
Los Angeles, California, United States, 90035
Contact: Alejandro T. Ponce, M.D.    310-557-9916    aponce@mednet.ucla.edu   
Contact: Ardis A. Moe, M.D.    310 557 2273    amoe@mednet.ucla.edu   
Principal Investigator: Ardis A. Moe, M.D.         
Sponsors and Collaborators
University of California, Los Angeles
Investigators
Principal Investigator: Ardis A Moe, M.D. UCLA Center for AIDS Research and Educationi
  More Information

No publications provided

Responsible Party: Ardis Ann Moe, M.D., Associate Professor of Medicine, University of California, Los Angeles
ClinicalTrials.gov Identifier: NCT01599975     History of Changes
Other Study ID Numbers: Concerta HIV Study
Study First Received: May 7, 2012
Last Updated: May 14, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by University of California, Los Angeles:
HAND
HIV Associated Neurocognitive Disorder
Methylphenidate
HIV Dementia

Additional relevant MeSH terms:
AIDS Dementia Complex
Dementia
Brain Diseases
Central Nervous System Diseases
Delirium, Dementia, Amnestic, Cognitive Disorders
HIV Infections
Immune System Diseases
Immunologic Deficiency Syndromes
Lentivirus Infections
Mental Disorders
Nervous System Diseases
RNA Virus Infections
Retroviridae Infections
Sexually Transmitted Diseases
Sexually Transmitted Diseases, Viral
Virus Diseases
Methylphenidate
Central Nervous System Agents
Central Nervous System Stimulants
Dopamine Agents
Dopamine Uptake Inhibitors
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Neurotransmitter Uptake Inhibitors
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on November 24, 2014