Study Stopped
This study was terminated early due to futility.
Minocycline for the Treatment of Decreased Mental Function in HIV-Infected Adults
Phase II, Randomized, Placebo-Controlled, Double-Blind Study of Minocycline in the Treatment of HIV-Associated Cognitive Impairment
2 other identifiers
interventional
107
1 country
16
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2 hiv-infections
Started Mar 2007
16 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 4, 2006
CompletedFirst Posted
Study publicly available on registry
August 8, 2006
CompletedStudy Start
First participant enrolled
March 1, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2010
CompletedResults Posted
Study results publicly available
July 26, 2011
CompletedFebruary 5, 2016
January 1, 2016
2.8 years
August 4, 2006
January 28, 2011
January 7, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change in Cognitive Performance Compared to Baseline
Th cognitive performance is measured by NPZ-8. NPZ-8 is defined as the average of age and education adjusted z-scores of eight neuropsychological tests subcomponents in the neuropsychological test battery. These eight tests are: 1. Grooved Pegboard Dominant Hand (GPD) 2. Grooved Pegboard Non-dominant hand (GPN) 3. Choice Reaction Time (CRT) 4. Sequential Reaction Time (QRT) 5. Timed Gait (TIG) 6. Trail Making Part A (TMA) 7. Trail Making Part B (TMB) 8. Symbol Digit (SYD) The primary outcome is NPZ-8 score at week24 - NPZ-8 score at baseline.
At baseline and week 24
Secondary Outcomes (23)
Change in Global Deficit Z-Score (GDS)
At baseline and week 24
Change in Investigator's Clinical Global Impression Score (ICGIS)
At week 24
Change in Cognitive Gross Motor Function Domain Z-Score
At baseline and week 24
Change in Fine Motor Function Domain Z-Score
At baseline and week 24
Change in Psychomotor Function Domain Z-Score
At baseline and week 24
- +18 more secondary outcomes
Study Arms (2)
Arm 1: Minocycline
EXPERIMENTAL100 mg orally every 12 hours
Arm 2: Matching placebo
PLACEBO COMPARATORorally every 12 hours
Interventions
Tetracycline antibiotic placebo, orally every 12 hours
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
- +3 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (16)
UCLA-David Geffen School of Medicine
Los Angeles, California, 90035, United States
University of California
San Diego, California, 92103, United States
University of Colorado Health Science Center
Denver, Colorado, 80262-3706, United States
The Ponce de Leon Ctr. CRS
Atlanta, Georgia, 30308, United States
Northwestern University CRS
Chicago, Illinois, 60611, United States
Johns Hopkins School of Medicine
Baltimore, Maryland, 21287-8106, United States
Massachusetts General Hospital, Division of Infectious Diseases
Boston, Massachusetts, 02114, United States
Henry Ford Hosp. CRS
Detroit, Michigan, 48202, United States
Washington University
St Louis, Missouri, 63108-2138, United States
NYU Med Ctr, Dept of Medicine
New York, New York, 10016, United States
1101 University of Rochester Medical Center, Division of Infectious Diseases
Rochester, New York, 14642, United States
University of North Carolina, AIDS Clinical Trials Unit
Chapel Hill, North Carolina, 27514, United States
The Research and Education Group - Portland CRS
Portland, Oregon, 97209, United States
University of Pennsylvania, ACTU
Philadelphia, Pennsylvania, 19104, United States
Virginia Commonwealth Univ. Medical Ctr. CRS
Richmond, Virginia, 23219, United States
Univ of Washington, Harborview Medical Ctr
Seattle, Washington, 98104, United States
Related Publications (5)
Bell JE. An update on the neuropathology of HIV in the HAART era. Histopathology. 2004 Dec;45(6):549-59. doi: 10.1111/j.1365-2559.2004.02004.x.
PMID: 15569045BACKGROUNDFerrari S, Vento S, Monaco S, Cavallaro T, Cainelli F, Rizzuto N, Temesgen Z. Human immunodeficiency virus-associated peripheral neuropathies. Mayo Clin Proc. 2006 Feb;81(2):213-9. doi: 10.4065/81.2.213.
PMID: 16471077BACKGROUNDZink MC, Uhrlaub J, DeWitt J, Voelker T, Bullock B, Mankowski J, Tarwater P, Clements J, Barber S. Neuroprotective and anti-human immunodeficiency virus activity of minocycline. JAMA. 2005 Apr 27;293(16):2003-11. doi: 10.1001/jama.293.16.2003.
PMID: 15855434BACKGROUNDSacktor N, Miyahara S, Deng L, Evans S, Schifitto G, Cohen BA, Paul R, Robertson K, Jarocki B, Scarsi K, Coombs RW, Zink MC, Nath A, Smith E, Ellis RJ, Singer E, Weihe J, McCarthy S, Hosey L, Clifford DB; ACTG A5235 team. Minocycline treatment for HIV-associated cognitive impairment: results from a randomized trial. Neurology. 2011 Sep 20;77(12):1135-42. doi: 10.1212/WNL.0b013e31822f0412. Epub 2011 Sep 7.
PMID: 21900636RESULTSacktor N, Miyahara S, Evans S, Schifitto G, Cohen B, Haughey N, Drewes JL, Graham D, Zink MC, Anderson C, Nath A, Pardo CA, McCarthy S, Hosey L, Clifford D; ACTG A5235 team. Impact of minocycline on cerebrospinal fluid markers of oxidative stress, neuronal injury, and inflammation in HIV-seropositive individuals with cognitive impairment. J Neurovirol. 2014 Dec;20(6):620-6. doi: 10.1007/s13365-014-0292-0. Epub 2014 Nov 7.
PMID: 25377444RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Limitations and Caveats
Originally, 100 participants were expected to enroll. As of the early termination notice, 107 participants were randomized, yet not all subjects could complete the 24 week assessment.
Results Point of Contact
- Title
- ACTG Clinicaltrials.gov Coordinator
- Organization
- ACTG Network Coordinating Center, Social and Scientific Systems, Inc.
Study Officials
- STUDY CHAIR
Ned Sacktor, MD
Department of Neurology, Johns Hopkins Bayview Medical Center
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, CARE PROVIDER
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- NETWORK
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 4, 2006
First Posted
August 8, 2006
Study Start
March 1, 2007
Primary Completion
January 1, 2010
Study Completion
January 1, 2010
Last Updated
February 5, 2016
Results First Posted
July 26, 2011
Record last verified: 2016-01