Cognitive Behavioral Therapy to Treat Insomnia in Persons With HIV Infection

Inclusion Criteria

• HIV-1 infection, documented by both: (1) any licensed rapid HIV test or HIV enzyme test kit at any time prior to study entry and (2) by at least one detectable HIV-1 antigen or at least one detectable plasma HIV-1 RNA viral load.
• Age equal to or greater than 18 years.
• Ongoing receipt of antiretroviral therapy of any kind for at least 3 months prior to the Entry Visit.
• HIV-1 RNA level 8.0 g/dL.
• Last known clinic-based total cholesterol > 240 mg/dL.
• Therapy for serious medical illnesses within 14 days prior to screening.

Note: Therapy for serious medical illnesses that overlaps with a main study visit will result in postponement of that study visit until the course of therapy is completed; postponement outside of the allowed study visit timeframe will result in study discontinuation.

• Pregnancy or breastfeeding during the course of the study.
• Receipt of investigational agents, cytotoxic chemotherapy, systemic glucocorticoids (of any dose), or anabolic steroids at the Entry Visit.

Note: Physiologic testosterone replacement therapy or topical steroids is not exclusionary. Inhaled/nasal steroids are not exclusionary as long as the participant is not also receiving HIV protease inhibitors.

• Active drug use or dependence that, in the opinion of the investigator, would interfere with adherence to study requirements.
• History of schizophrenia, bipolar disorder, or dementia.

NOTE: Depression is not exclusionary as long as the severity of depression does impede ability to perform the required study procedures.

• Musculoskeletal or neurologic disorders that impede ability to perform the required study procedures.
• History of sleep apnea or restless leg syndrome.