CC-11050 200mg (2 capsules) BID with food

HIV, Inflammation

Assess the safety of a 12-week course if CC-1150 in HIV-infected adults who have been on ART for greater than or equal to 1 year and have suppressed plasma viremia

Assess Safety

Evaluate the effect of CC-11050 on plasma HIV-1 RNA levels by both conventional and single copy assay at week 12 and over all evaluable time points

Effect of drug on viral load

Evaluate the effect of CC-11050 on CD4+ T cell counts and percentages at week 12 and over all evaluable time points

Effect of drug on T-cell count

Evaluate the effect of CC-11050 on markers of markers of systemic inflammation (TNF, IL-^, CRP, IFNg, sCD14, D-dimer) at week 12 and over all evaluable time points.

Effect of drug on inflammatory biomarkers

National Institutes of Health Clinical Center, 9000 Rockville Pike

CC-11050 in Human Immunodeficiency Virus-1-Infected Adults With Suppressed Plasma Viremia on Antiretroviral Therapy (APHRODITE)

A Phase 1 Study of CC-11050 in Human Immunodeficiency Virus-1-Infected Adults With Suppressed Plasma Viremia on Antiretroviral Therapy

National Institute of Allergy and Infectious Diseases (NIAID)

This group will be CML patients. In this group each participant will be asked to wear a watch "Actigraph" for one week.
He will be asked to fill the appropriate questionnaires, and a daily sleep diary.

The control group will be non-CML patients, also without any known malignancy or known sleep disturbances.
They will be asked to wear the watch "Actigraph" for one week, and to fill the appropriate questionnaires and a daily sleep diary.

Sleep Disorder

Chronic Myeloid Leukemia

The watch will measure sleep parameters like quality of sleep, time to fall asleep, number of awakenings during night, length of deep sleep.

Actigraph

Sleep Assessment in CML

OBJECTIVE AND SUBJECTIVE ASSESSMENT OF SLEEP QUALITY IN PATIENTS WITH CHRONIC MYELOGENOUS LEUKEMIA

The prevalence will be compared to the Control group in the study and to the prevalnce of sleep disturbances reported in other studies.

The investigators will correlate between the subjective and the objective results. the investigators will seek correlation between the anxiety, quality of life and depression questionnaires and the subjective reports of sleep disturbances and whether these reports supported objectively or not

The characteristics that will be used will be: the duration of the disease, the clinical response to therapy, the type of therapy that the patients receive.

iris/fatigue

CC-11050 in Human Immunodeficiency Virus-1-Infected Adults With Suppressed Plasma Viremia on Antiretroviral Therapy (APHRODITE)

Sleep Assessment in CML

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