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

NCT01599975 | Unknown Phase 3 DMC

• 1 other identifier: Concerta HIV Study
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

HIV Dementia

Keywords

HAND; HIV Associated Neurocognitive Disorder; Methylphenidate; HIV Dementia

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• Number of Subjects with Adverse Events as Measures of Safety and Tolerability of Concerta in HIV infected adults

  10 weeks of drug exposure

Study Arms (2)

Group A: 2 tabs of 18 mg Concerta daily

ACTIVE COMPARATOR

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

Group B: Matched placebo, 2 tabs daily

PLACEBO COMPARATOR

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

Interventions

Long acting methylphenidate DRUG

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

Also known as: Concerta

Group A: 2 tabs of 18 mg Concerta daily

Matched placebo DRUG

2 tablets of matched placebo daily by mouth

Also known as: Matched placebo as supplied by Johnson and Johnson

Group B: Matched placebo, 2 tabs daily

Eligibility Criteria

• Age: 18 Years - 64 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of California, Los Angeles: lead

Study Sites (1)

UCLA CARE Clinic

Los Angeles, California, 90035, United States

RECRUITING

MeSH Terms

Conditions

AIDS Dementia Complex

Interventions

Methylphenidate

Condition Hierarchy (Ancestors)

HIV Infections; Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases; Neurocognitive Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Phenylacetates; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Ardis A Moe, M.D.

  UCLA Center for AIDS Research and Educationi

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Alejandro T. Ponce, M.D.

CONTACT

310 557 9916; aponce@mednet.ucla.edu

Ardis A. Moe, M.D.

CONTACT

310 557 2273; amoe@mednet.ucla.edu

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Medicine

Study Record Dates

• First Submitted: May 7, 2012
• First Posted: May 16, 2012
• Study Start: May 1, 2012
• Primary Completion: May 1, 2014
• Study Completion: September 1, 2014
• Last Updated: May 16, 2012

Record last verified: 2012-05

Locations

US (1)