Minocycline for the Treatment of Decreased Mental Function in HIV-Infected Adults

Exclusion Criteria

• •Plan to stay on current ART regimen between study screening and Week 24
• •AIDS Dementia Scale (ADC) Stage greater than 0
• •Cognitive impairment, as evidenced by neuropsychological tests administered at screening
• •Progressive neurocognitive decline. More information on this criterion can be found in the protocol.
• •Estimated premorbid IQ of 70 or higher indicated by an age-corrected scaled score of 5 or higher on the vocabulary section of the Wechsler Adult Intelligence Scale Revised (WAIS-R) administered at study screening
• •Karnofsky performance score of 60 or higher
• •Ability to sit and stand for at least 2 hours and swallow medications with an 8-ounce glass of water
• •Willing to use acceptable methods of contraception
• •Willing to adhere to study schedule
• •Current cancers. Patients with basal cell carcinoma, in situ carcinoma of the cervix, or Kaposi's sarcoma without evidence of visceral involvement or cancer not requiring systemic chemotherapy are not excluded.
• •Severe premorbid psychiatric illness, including schizophrenia and major depression, which, in the opinion of the investigator, may interfere with the study
• •Active symptomatic AIDS-defining opportunistic infection within 45 days prior to study entry
• •Previous or current confounding neurological disorders. More information on this criterion can be found in the protocol.
• •Central nervous system infections or cancers. More information on this criterion can be found in the protocol.
• •Systemic lupus
• •Thyroid disease diagnosed within 24 weeks of study entry
• •Active drug or alcohol abuse that, in the opinion of the investigator, may interfere with the study
• •Serious illness requiring systemic treatment or hospitalization. Patients who complete therapy or are clinically stable on therapy are not excluded.
• •Investigational agents within 45 days prior to study entry. Patients taking expanded access drugs or drugs used in an ACTG protocol for HIV treatment or for HIV-associated complications that are not prohibited by this protocol are not excluded.
• •History of allergy/sensitivity to minocycline or other tetracyclines and their formulations
• •Any esophageal or other condition that would interfere with a patient's ability to swallow study medication
• •Participation in a previous clinical drug research trial of HIV-associated cognitive impairment. Patients who have had an objective decline in performance as defined by the protocol are not excluded.
• •Any other clinically significant condition or laboratory abnormality that, in the opinion of the investigator, would interfere with the study
• •Certain medications
• •Certain abnormal laboratory values. Patients who test positive on nonreactive rapid plasma reagin tests (RPR)are not excluded.
• •Inability to undergo lumbar punctures
• •Breastfeeding