Clinical trial: A Study Comparing Long-acting Methylphenidate (ConcertaTM) vs. Placebo in the Treatment of Memory Loss Due to HIV (NCT01599975)

Eligibility 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.

        -
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
Subject must be at most 64 Years

Patient description (medical language): A 23-year-old man comes to the emergency department following an episode of syncope.  He was working out when he felt dizzy and passed out without head injury.  He has had 3 other episodes of light-headedness over the last year, all happening during physical activity. He never had this experience while resting. He has no other medical conditions.  The patient does not use tobacco, alcohol, or illicit drugs.  His father died suddenly at age 35.  Vital signs are within normal limits.  On physical examination, the patient has a harsh systolic murmur.  The lungs are clear with no peripheral edema. Echocardiography shows asymmetric interventricular septal hypertrophy.

Patient description (patient's own words): I'm 23, and I got admitted to the ER because I fainted all of a sudden. I was in the gym, working out, when all of a sudden, I just got dizzy and passed out. Hopefully, I didn't hit my head. It's not my first time having that kind of dizziness at the gym, never when I'm chilling at home tho. I don't have any special medical conditions and I'm not even smoking, drinking or doing drugs! My dad died suddenly when he was 35, so I'm kind of scared. My vitals were normal while at the ER and they did a physical exam and they told me my heart sounds abnormal. My lungs are ok, but I had to do an echography of my heart, and they told me it is bigger than average.

Does the patient match the trial criteria? Contradiction