Minocycline for HIV+ Cognitive Impairment in Uganda
Information source: Johns Hopkins University
Information obtained from ClinicalTrials.gov on October 19, 2009
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: HIV-associated Cognitive Impairment; HIV Infections
Intervention: minocycline (Drug); minocycline placebo capsule (Drug)
Phase: Phase 1/Phase 2
Status: Recruiting
Sponsored by: Johns Hopkins University Official(s) and/or principal investigator(s):
Ned Sacktor, MD, Principal Investigator, Affiliation: Johns Hopkins School of Medicine
Overall contact:
Noeline Nakasujja, MD, Phone: (011) 256 41 430 7289, Email: drnoeline@yahoo.com
Summary
Purpose: The purpose of the study is to assess the safety and effectiveness of minocycline,
an antibiotic, in the treatment of HIV-associated cognitive impairment in Uganda.
Study Design: Treatment, 24-week Randomized, Placebo-Controlled, Double-Blind Phase with
Optional 24-week Open Label Phase for Subjects with a CD4 Count in the 251-350 Range
- Arm 1: Minocycline 100 mg orally every 12 hours (50 subjects)
- Arm 2: Matching placebo orally every 12 hours (50 subjects)
Primary Outcome Measure:
· To examine whether minocycline treatment will improve cognitive performance after 24 weeks
compared to baseline
Secondary Outcome Measures:
- To examine whether minocycline treatment for 24 weeks is safe and well-tolerated in
individuals with HIV-associated cognitive impairment
- To examine whether minocycline treatment for 48 weeks is safe and well-tolerated in
individuals with HIV-associated cognitive impairment
- To examine whether minocycline treatment for 24 weeks improves functional impairment
Clinical Details
Official title: Minocycline in the Treatment of HIV-Associated Cognitive Impairment in Uganda
Study design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Single Group Assignment, Safety/Efficacy Study
Primary outcome: · To examine whether minocycline treatment will improve cognitive performance after 24 weeks compared to baseline
Secondary outcome: · To examine whether minocycline treatment for 24 weeks is safe and well-tolerated in individuals with HIV-associated cognitive impairment· To examine whether minocycline treatment for 48 weeks is safe and well-tolerated in individuals with HIV-associated cognitive impairment · To examine whether minocycline treatment for 24 weeks improves functional impairment
Detailed description:
Inclusion Criteria
- HIV infection prior to study entry
- Naïve to any antiretroviral regimen and ineligible to receive antiretroviral therapy by
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 Criteria
- 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
Eligibility
Minimum age: 18 Years.
Maximum age: 65 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- · HIV infection prior to study entry
- Naïve to any antiretroviral regimen and ineligible to receive antiretroviral
therapy by 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 Criteria
- 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
Exclusion Criteria:
-
Locations and Contacts
Noeline Nakasujja, MD, Phone: (011) 256 41 430 7289, Email: drnoeline@yahoo.com
Infecious Diseas Institute, Kampala, Uganda; Recruiting
Noeline Nakasuijja, MD, Principal Investigator
Additional Information
Website of NARC, the sponsoring grant for this trial
Starting date: April 2008
Ending date: August 2010
Last updated: September 8, 2009
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