Minocycline for the Treatment of Decreased Mental Function in HIV-Infected Adults
Condition: HIV Infections
MeSH terms: HIV Infections
Intervention: Minocycline; Placebo (Tetracycline)
Intervention description: Tetracycline antibiotic, 100 mg taken orally every 12 hours; Tetracycline antibiotic placebo, orally every 12 hours
Intervention MeSH terms: Minocycline; Tetracycline
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Enrollment: 107.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: Treatment Experienced

Summary:

      The purpose of this study is to determine the effectiveness of minocycline, an antibiotic, in
      lessening the decreased mental function sometimes caused by anti-HIV drugs.
    

Eligibility criteria:

        Inclusion Criteria:

          -  HIV infected

          -  Currently on a stable ART regimen for at least 16 consecutive weeks prior to study
             entry. Participants whose regimens have changed with respect to dose or formulation
             are eligible, but patients who have changed to different drugs in the same class are
             not eligible. Participants taking atazanavir must also be taking ritonavir or a
             ritonavir-boosted drug to be eligible for this study. More information on this
             criterion can be found in the protocol.

          -  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

        Exclusion Criteria:

          -  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