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Minocycline for HIV+ Cognitive Impairment in Uganda

This study has been terminated.
(The Neurologic AIDS Research Consortium Data Safety and Monitoring Board committee recommended to terminate the study early due to futility on 11/6/2009.)
Sponsor:
Collaborator:
Makerere University
Information provided by:
Johns Hopkins University
ClinicalTrials.gov Identifier:
NCT00855062
First received: March 2, 2009
Last updated: January 28, 2011
Last verified: January 2011
History of Changes
Results First Received: December 17, 2010  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Conditions: HIV-associated Cognitive Impairment
HIV Infections
Interventions: Drug: minocycline
Drug: minocycline placebo capsule

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
The recruitment period was from Mar 2008 to Oct 2009 when the study was stopped early (Data and Safety Monitoring Board (DSMB) decision based on futility) on Nov 2009. The study participants were recruited from the Infectious Disease Institute, Makerere University, Kampala, Uganda.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Total of 353 participants were screened; only 73 were randomized and thus 280 were not enrolled: 146 of them did not have cognitive impairment, 55 of them lacked laboratory inclusion criteria, and 79 of them had "others".

Reporting Groups
  Description
Minocycline Minocycline 100 mg orally every 12 hours
Placebo Placebo minocycline capsules every 12 hours

Participant Flow for 2 periods

 Period 1:   Step1
    Minocycline     Placebo  
STARTED     36     37  
COMPLETED     26     26  
NOT COMPLETED     10     11  
Early Study Closure                 5                 7  
Adverse Event                 1                 1  
Protocol Violation                 1                 0  
Pregnancy                 1                 0  
Withdrawal by Subject                 2                 3  

Period 2:   Step2
    Minocycline     Placebo  
STARTED     19 [1]   21 [2]
COMPLETED     13     15  
NOT COMPLETED     6     6  
Early Study Closure                 6                 2  
Adverse Event                 0                 3  
Initiation of antiretroviral therapy/ART                 0                 1  
[1] 26 participants completed STEP1; however, only 19 out of the 26 decided to enroll in STEP2.
[2] 26 participants completed STEP1; however, only 21 out of the 26 decided to enroll in STEP2.



  Baseline Characteristics
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  Outcome Measures
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1.  Primary:   24-week Change of Uganda Neuropsychological Test Battery Summary Measure (U NP Sum)   [ Time Frame: At baseline and week 24 ]
  Show Outcome Measure 1

2.  Secondary:   24-week Change of Memorial Sloan Kettering (MSK) HIV Dementia Stage   [ Time Frame: At baseline and week 24 ]
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3.  Secondary:   24-week Change of Karnofsky Performance Score   [ Time Frame: At baseline and week 24 ]
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4.  Secondary:   Time From Treatment Initiation to the Development of a Grade ≥ 2 Toxicity and/or Sign and Symptoms.   [ Time Frame: Time of initial Grade ≥ 2 toxicity and/or sign and symptom event up to week 24 ]
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5.  Secondary:   Time From Treatment Initiation to the Development of a Grade ≥ 2 Toxicity and/or Sign and Symptoms   [ Time Frame: Time of first Grade ≥ 2 toxicity and/or sign and symptom event up to 48 weeks ]
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6.  Secondary:   24-week Change of CD4 Cell Counts   [ Time Frame: At baseline and week 24 ]
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7.  Secondary:   48-week Change of CD4 Cell Counts   [ Time Frame: At baseline and week 48 ]
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8.  Secondary:   24-week Change of Instrumental Activities of Daily Living   [ Time Frame: At baseline and week 24 ]
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9.  Secondary:   24-week Change of HIV RNA Plasma Viral Loads (Log10 Transformed)   [ Time Frame: At baseline and week 24 ]
  Show Outcome Measure 9

10.  Secondary:   24-week Change of Center for Epidemiologic Studies Depression (CES-D) Score   [ Time Frame: At baseline and week 24 ]
  Show Outcome Measure 10


  Serious Adverse Events
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  Other Adverse Events
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Limitations and Caveats
Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
The estimated sample size was 100; however, due to early termination of the study, the total number of randomized participants was 73.  


Results Point of Contact:  
Name/Title: Sachiko Miyahara
Organization: Harvard School of Public Health
phone: 617-432-2837
e-mail: miyahara@sdac.harvard.edu


No publications provided


Responsible Party: Ned Sacktor, MD, Johns Hopkins School of Medicine
ClinicalTrials.gov Identifier: NCT00855062     History of Changes
Other Study ID Numbers: Uganda minocycline study, Grant Number: 5 UO1 NS32228
Study First Received: March 2, 2009
Results First Received: December 17, 2010
Last Updated: January 28, 2011
Health Authority: United States: Federal Government
United States: NINDS appointed Data Safety Monitoring Committee for the Neurologic AIDS Research Consortium