Status:
TERMINATED
Minocycline for HIV+ Cognitive Impairment in Uganda
Lead Sponsor:
Johns Hopkins University
Collaborating Sponsors:
Makerere University
Conditions:
HIV-associated Cognitive Impairment
HIV Infections
Eligibility:
All Genders
18-65 years
Phase:
PHASE1
PHASE2
Brief Summary
Purpose: The purpose of the study is to assess the safety and effectiveness of minocycline, an antibiotic, in the treatment of Human immunodeficiency virus (HIV)-associated cognitive impairment in Uga...
Eligibility Criteria
Inclusion
- HIV infection prior to study entry
- Naïve to any antiretroviral regimen and ineligible to receive antiretroviral therapy by cluster of differentiation 4 (CD4) criteria in Uganda
- Negative serum or urine pregnancy test for women of childbearing potential
- Willingness to use birth control
- Age 18-65 years
- AIDS Dementia Scale Stage 0.5 OR 1
- Impaired cognitive performance as evidenced by an International HIV Dementia Scale (HDS) as defined by the protocol
- Ability to sit or stand and swallow intact capsules with an 8-ounce glass of water
- Ability and willingness of subject or legal guardian/ representative to give written informed consent
- Resident within a 20km radius of Kampala city
Exclusion
- Current cancers other than basal cell carcinoma, in situ carcinoma of the cervix, or Kaposi's sarcoma without evidence of visceral involvement or which does not require systemic chemotherapy
- Severe premorbid psychiatric illness, including schizophrenia and major depression which, in the in investigator's opinion, is likely to interfere with study compliance
- Active symptomatic AIDS-defining opportunistic infection within 45 days prior to study entry
- Confounding neurological disorders as defined in the protocol
- Central nervous system infections or cancers as defined in the protocol
- Systemic lupus
- Thyroid disease diagnosed within 24 weeks prior to entry
- Breastfeeding
- Active drug or alcohol use or dependence that, in the opinion of the investigator, would interfere with adherence to study requirements
- Serious illness requiring systemic treatment and/or hospitalization until subject either completes therapy or is clinically stable on therapy, in the opinion of the investigator
- History of allergy/sensitivity to minocycline or other tetracyclines and their formulations
- Any other clinically significant condition or laboratory abnormality that, in the opinion of the investigator, would interfere with the subject's ability to participate in the study. This includes an individual found to have an HIV dementia scale stage 3 or 4.
- Any esophageal or other condition that would interfere with the swallowing of the study medication
- Use of excluded drugs as defined by the protocol
Key Trial Info
Start Date :
April 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2009
Estimated Enrollment :
73 Patients enrolled
Trial Details
Trial ID
NCT00855062
Start Date
April 1 2008
End Date
December 1 2009
Last Update
February 25 2011
Active Locations (1)
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1
Infecious Diseas Institute
Kampala, Uganda